## Protocol Section
### Identification Module
**NCT ID:** NCT00003479

**Brief Title:** Antineoplaston Therapy in Treating Patients With Ependymoma

**Official Title:** Phase II Study of Antineoplastons A10 and AS2-1 Infusions in Patients With Ependymoma

#### Organization Study ID Info
**ID:** CDR0000066516
#### Organization
**Class:** OTHER
**Full Name:** Burzynski Research Institute
#### Secondary ID Infos
**Domain:** Burzynski Research Institute, Inc.
**ID:** BC-BT-24
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2000-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-02-23

**Type:** ACTUAL

**Last Update Submit Date:** 2022-02-18

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2000-10

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2017-02-17

**Type:** ACTUAL

**Results First Submit Date:** 2016-12-28

**Results First Submit QC Date:** 2016-12-28

#### Start Date
**Date:** 1966-07

**Status Verified Date:** 2022-02

#### Study First Post Date
**Date:** 2003-01-27
**Type:** ESTIMATED
**Study First Submit Date:** 1999-11-01
**Study First Submit QC Date:** 2003-01-26
**Why Stopped:** Slow accrual
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Burzynski Research Institute

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** RATIONALE: Current therapies for patients with ependymoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of patients with ependymoma .

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with ependymoma.

**Detailed Description:** OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in patients with ependymoma as measured by an objective response to therapy (complete response, partial response) or stable disease.
* To determine the safety and tolerance of Antineoplaston therapy in patients with ependymoma

OVERVIEW: This is a single arm, open-label study in which patients with ependymoma receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with a complete or partial response or with stable disease may continue treatment.

To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study

### Conditions Module

**Conditions:**

- Ependymoma

**Keywords:**

- Ependymoma

- Anaplastic Ependymoma

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 9

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.

**Intervention Names:**

- Drug: Antineoplaston therapy (Atengenal + Astugenal)

**Label:** Antineoplaston therapy

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Antineoplaston therapy

**Description:** Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal).

**Name:** Antineoplaston therapy (Atengenal + Astugenal)

**Other Names:**

- A10 (Atengenal); AS2-1 (Astugenal)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), \>=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), \<50% decrease and \<25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), \>=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.

**Measure:** Number of Participants With Objective Response

**Time Frame:** 12 months

#### Secondary Outcomes

**Description:** 6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival

**Measure:** Percentage of Participants Who Survived

**Time Frame:** 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

### Eligibility Module

**Eligibility Criteria:** DISEASE CHARACTERISTICS:

* Histologically confirmed ependymoma that is unlikely to respond to existing therapy and for which no curative therapy exists
* Evidence of residual tumor (\>= 5mm) by MRI scan performed within two weeks prior to study entry
* No brain stem tumors

PATIENT CHARACTERISTICS:

Age:

* 6 months and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* At least 2 months

Hematopoietic:

* WBC at least 2,000/mm3
* Platelet count greater than 50,000/mm3

Hepatic:

* Bilirubin no greater than 2.5 mg/dL
* SGOT/SGPT no greater than 5 times upper limit of normal
* No hepatic failure

Renal:

* Creatinine no greater than 2.5 mg/dL
* No renal failure
* No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

* No severe heart disease
* No uncontrolled hypertension
* No history of congestive heart failure
* No history of other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

* No severe lung disease

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 4 weeks after study
* No serious active infections or fever
* No other serious concurrent disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior immunotherapy and recovered
* No concurrent immunomodulating agents

Chemotherapy:

* At least 4 weeks since prior chemotherapy and recovered (6 weeks for nitrosoureas)
* No concurrent antineoplastic agents

Endocrine therapy:

* Concurrent corticosteroids for cerebral edema allowed (must be on stable dose for at least 1 week prior to study)

Radiotherapy:

* At least 8 weeks since prior radiotherapy and recovered

Surgery:

* Not specified

Other:

* No prior antineoplaston therapy

**Maximum Age:** 99 Years

**Minimum Age:** 6 Months

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Houston

**Country:** United States

**Facility:** Burzynski Clinic

**State:** Texas

**Zip:** 77055-6330

#### Overall Officials

**Official 1:**

**Affiliation:** Burzynski Research Institute

**Name:** Stanislaw R. Burzynski, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### See Also Links

**Label:** Burzynski Research Institute

**URL:** http://www.burzynskiresearch.com

**Label:** Burzynski Clinic

**URL:** http://www.burzynskiclinic.com

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005910

- Term: Glioma

- ID: D000018302

- Term: Neoplasms, Neuroepithelial

- ID: D000017599

- Term: Neuroectodermal Tumors

- ID: D000009373

- Term: Neoplasms, Germ Cell and Embryonal

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009380

- Term: Neoplasms, Nerve Tissue

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M7965

- Name: Ependymoma

- Relevance: HIGH

- As Found: Ependymoma

- ID: M9020

- Name: Glioma

- Relevance: LOW

- As Found: Unknown

- ID: M20446

- Name: Neoplasms, Neuroepithelial

- Relevance: LOW

- As Found: Unknown

- ID: M19845

- Name: Neuroectodermal Tumors

- Relevance: LOW

- As Found: Unknown

- ID: M20388

- Name: Neuroectodermal Tumors, Primitive

- Relevance: LOW

- As Found: Unknown

- ID: M12318

- Name: Neoplasms, Germ Cell and Embryonal

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12325

- Name: Neoplasms, Nerve Tissue

- Relevance: LOW

- As Found: Unknown

- ID: T2093

- Name: Ependymoma

- Relevance: HIGH

- As Found: Ependymoma

- ID: T365

- Name: Anaplastic Ependymoma

- Relevance: LOW

- As Found: Unknown

- ID: T2519

- Name: Glioma

- Relevance: LOW

- As Found: Unknown

- ID: T4092

- Name: Neuroepithelioma

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004806

- Term: Ependymoma

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Nine patients were recruited between July 1996 and March 2000. All study subjects were seen at the Burzynski Clinic in Houston TX

#### Event Groups

**Group ID:** EG000

**Title:** Antineoplaston Therapy

**Description:** Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.

Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal).

**ID:** EG000

**Other Num Affected:** 9

**Other Num at Risk:** 9

**Serious Number Affected:** 5

**Serious Number At Risk:** 9

**Title:** Antineoplaston Therapy

**Frequency Threshold:** 5

#### Other Events

**Term:** Allergic reaction/hypersensitivity (including drug fever)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Hemoglobin

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Leukocytes (total WBC)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Lymphopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Neutrophils/granulocytes (ANC/AGC)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Central venous catheter infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** Institutional

**Term:** Non-functional central venous catheter

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** Institutional

**Term:** Fatigue (asthenia, lethargy, malaise)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Fever

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Rigors/chills

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Weight gain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Pruritus/itching

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Rash: erythema multiforme

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Edema/Fluid retention

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** Institutional

**Term:** Diarrhea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Hemorrhage, GU: Bladder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Pancreatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Infection (documented clinically): Bladder (urinary)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Infection (documented clinically): Blood

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Infection (documented clinically): Mucosa

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Infection (documented clinically): Pharynx

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Infection (documented clinically): Sinus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Infection (documented clinically): Soft tissue NOS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Infection (documented clinically): Urinary tract NOS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Middle ear (otitis media)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Skin

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Upper airway

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Hyperglycemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Hypernatremia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Hyperuricemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Hypocalcemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Hypochloremia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Hypoglycemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Hypokalemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Metabolic/Laboratory - Other

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Proteinuria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

**Term:** SGOT

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

**Term:** SGPT

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Apnea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Ataxia (incoordination)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Confusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Neuropathy: cranial: CN VIII Hearing and balance

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Neuropathy: sensory

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Seizure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Somnolence/depressed level of consciousness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Speech impairment

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Syncope (fainting)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Pain: Dental/teeth/peridontal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Pain: Head/headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Pain: Joint

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Pain: Stomach

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Dyspnea (shortness of breath)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** CTCAE (3.0)

#### Serious Events

**Term:** Hemoglobin

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** The Hemoglobin was not related to Antineoplaston therapy.

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** CTCAE (Version 3

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 9

**Term:** Central venous catheter infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** The Central venous catheter infection was not related to Antineoplaston therapy.

**Organ System:** Infections and infestations

**Source Vocabulary:** Institutional

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 9

**Term:** Rash: erythema multiforme

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** The Rash: erythema multiforme was possibly related to Antineoplaston therapy.

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 9

**Term:** Pancreatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** The Pancreatitis was not related to Antineoplaston therapy.

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 9

**Term:** Infection (documented clinically): Blood

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** The Infection (documented clinically): Blood was not related to Antineoplaston therapy.

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 9

**Term:** Hypokalemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** The Hypokalemia was possibly related to Antineoplaston therapy.

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 9

**Term:** Confusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** The Confusion was possibly related to Antineoplaston therapy.

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 9

**Term:** Seizure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** The Seizure was not related to Antineoplaston therapy.

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 9

**Term:** Somnolence/depressed level of consciousness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** The Somnolence/depressed level of consciousness was not related to Antineoplaston therapy.

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 9

**Term:** Pain: Joint

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** The Pain: Joint was possibly related to Antineoplaston therapy.

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 9

**Term:** Pain: Stomach

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** The Pain: Stomach was not related to Antineoplaston therapy.

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 9

**Time Frame:** 4 years, 2 months

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 9

**Units:** Participants

### Group

**ID:** BG000

**Title:** Antineoplaston Therapy

**Description:** Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.

Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal).

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 1.6

**Upper Limit:** 35.7

**Value:** 7.3

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 5

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 4

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEDIAN
**Title:** Age, Continuous
**Unit of Measure:** Years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** srb@burzynskiclinic.com
**Organization:** Burzynski Research Institute, Inc.
**Phone:** 713-335-5664
**Title:** S. R. Burzynski, MD, PhD
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 66.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 44.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 33.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 22.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 22.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11.1
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), \>=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), \<50% decrease and \<25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), \>=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 12 months
**Title:** Number of Participants With Objective Response
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.

Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal).
**ID:** OG000
**Title:** Antineoplaston Therapy
#### Outcome Measure 2
**Description:** 6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival
**Parameter Type:** NUMBER
**Population Description:** All study subjects receiving any Antineoplaston therapy
**Reporting Status:** POSTED
**Time Frame:** 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
**Title:** Percentage of Participants Who Survived
**Type:** SECONDARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.

Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal).
**ID:** OG000
**Title:** Antineoplaston Therapy
### Participant Flow Module
#### Group
**Description:** Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.

Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal).
**ID:** FG000
**Title:** Antineoplaston Therapy
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Not evaluable
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 9
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 6
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 3
**Recruitment Details:** Nine patients were recruited between July 1996 and October 2000. All study subjects were seen at the Burzynski Clinic in Houston TX.
**Has Results:** True