## Protocol Section
### Identification Module
**NCT ID:** NCT00045279

**Brief Title:** PEG-Interferon Alfa-2b in Treating Patients With Metastatic Kidney Cancer

**Official Title:** Phase II Trial of PEG-Intron in Patients With Advanced Renal Cell Carcinoma

#### Organization Study ID Info
**ID:** 01-143
#### Organization
**Class:** OTHER
**Full Name:** Memorial Sloan Kettering Cancer Center
#### Secondary ID Infos
**Domain:** PDQ (Physician Data Query)
**ID:** CDR0000256464
**Type:** REGISTRY
**ID:** NCI-G-02-2102
### Status Module
#### Completion Date
**Date:** 2005-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-06-05

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-06-04

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2005-09

**Type:** ACTUAL

#### Start Date
**Date:** 2002-04

**Status Verified Date:** 2013-06

#### Study First Post Date
**Date:** 2003-01-27
**Type:** ESTIMATED
**Study First Submit Date:** 2002-09-06
**Study First Submit QC Date:** 2003-01-26
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Lead Sponsor

**Class:** OTHER

**Name:** Memorial Sloan Kettering Cancer Center

### Description Module

**Brief Summary:** RATIONALE: PEG-interferon alfa-2b may stop the growth of kidney cancer by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating patients who have metastatic kidney cancer.

**Detailed Description:** OBJECTIVES:

* Determine the efficacy of PEG-interferon alfa-2b in patients with metastatic renal cell carcinoma.
* Determine the time to disease progression in patients treated with this drug.
* Determine the safety of this drug in these patients.
* Determine the quality of life of patients treated with this drug.
* Determine the effect of this drug on biological surrogates of antitumor activity (basic fibroblast growth factor, vascular endothelial growth factor, and interleukin-6 serum levels) in these patients.

OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at 2 weeks and at 2, 4, 8, and 12 months after initiation of study therapy, and then at completion of study therapy.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 15 months.

### Conditions Module

**Conditions:**

- Kidney Cancer

**Keywords:**

- stage IV renal cell cancer

### Design Module

#### Design Info

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** PEG-interferon alfa-2b

**Type:** BIOLOGICAL

### Eligibility Module

**Eligibility Criteria:** DISEASE CHARACTERISTICS:

* Histologically confirmed renal cell carcinoma

  * Metastatic disease
  * No prior therapy for advanced disease
* Tumor sample available for molecular analysis with prior registration on MSKCC IRB # 89-076
* Bidimensionally measurable disease
* No brain metastases unless completely resected and without evidence of recurrence for at least six months

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Karnofsky 70-100%

Life expectancy

* Not specified

Hematopoietic

* WBC at least 3,000/mm3
* Platelet count at least 100,000/mm3

Hepatic

* Bilirubin no greater than 1.5 mg/dL
* SGOT no greater than 2.5 times upper limit of normal (unless due to hepatic metastases)
* Hepatitis B surface antigen negative
* Hepatitis C negative

Renal

* Creatinine no greater than 2 mg/dL

Cardiovascular

* No severe cardiac disease
* No New York Heart Association class III or IV cardiac disease
* No myocardial infarction within the past 12 months
* No ventricular tachyarrhythmias requiring ongoing treatment
* No unstable angina

Pulmonary

* No severe asthma requiring chronic systemic steroids

Other

* HIV negative
* Negative pregnancy test
* Fertile patients must use effective contraception
* No malignancy within the past 2 years except basal cell or squamous cell skin cancer, superficial bladder cancer, or localized prostate cancer

  * Patients who have undergone potentially curative therapy and have been deemed to be at low risk for recurrence are eligible
* No medically significant psychiatric disease (e.g., endogenous depression, psychosis, or bipolar disease) requiring hospitalization
* No prior or active autoimmune disease
* Medically controlled diabetes or thyroid dysfunction allowed
* No clinically significant acute viral or bacterial infection that requires specific therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No prior interleukin-2
* No prior interferon alfa
* No concurrent cytokines or biological response modifiers except epoetin alfa in the case of hematologic compromise
* No concurrent tumor vaccines
* No concurrent monoclonal antibodies
* No concurrent bone marrow/stem cell transplantation

Chemotherapy

* No concurrent cytotoxic agents

Endocrine therapy

* No concurrent high-dose systemic steroids
* Concurrent low-dose corticosteroids (e.g., asthma inhalers, topical creams, or intra-articular injections) allowed
* No concurrent hormonal therapy (including megestrol)
* Concurrent hormone replacement therapy or oral contraceptives allowed

Radiotherapy

* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy

Surgery

* See Disease Characteristics
* At least 4 weeks since prior major surgery
* Concurrent nephrectomy allowed

Other

* At least 14 days since prior anti-infectious therapy
* No other concurrent investigational drugs

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New York

**Country:** United States

**Facility:** Memorial Sloan-Kettering Cancer Center

**State:** New York

**Zip:** 10021

#### Overall Officials

**Official 1:**

**Affiliation:** Memorial Sloan Kettering Cancer Center

**Name:** Robert J. Motzer, MD

**Role:** STUDY_CHAIR

### References Module

#### References

**Citation:** Feldman DR, Kondagunta GV, Schwartz L, Patil S, Ishill N, DeLuca J, Russo P, Motzer RJ. Phase II trial of pegylated interferon-alpha 2b in patients with advanced renal cell carcinoma. Clin Genitourin Cancer. 2008 Mar;6(1):25-30. doi: 10.3816/cgc.2008.n.004.

**PMID:** 18501079

**Citation:** Motzer RJ, Rakhit A, Thompson J, Gurney H, Selby P, Figlin R, Negrier S, Ernst S, Siebels M, Ginsberg M, Rittweger K, Hooftman L. Phase II trial of branched peginterferon-alpha 2a (40 kDa) for patients with advanced renal cell carcinoma. Ann Oncol. 2002 Nov;13(11):1799-805. doi: 10.1093/annonc/mdf288.

**PMID:** 12419754

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014571

- Term: Urologic Neoplasms

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000000230

- Term: Adenocarcinoma

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M5548

- Name: Carcinoma, Renal Cell

- Relevance: HIGH

- As Found: Kidney Cancer

- ID: M10703

- Name: Kidney Neoplasms

- Relevance: HIGH

- As Found: Kidney Cancer

- ID: M17320

- Name: Urologic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: T4906

- Name: Renal Cell Carcinoma

- Relevance: HIGH

- As Found: Kidney Cancer

- ID: T1341

- Name: Clear Cell Renal Cell Carcinoma

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007680

- Term: Kidney Neoplasms

- ID: D000002292

- Term: Carcinoma, Renal Cell

### Intervention Browse Module - Ancestors

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000000998

- Term: Antiviral Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M10407

- Name: Interferons

- Relevance: HIGH

- As Found: Recurrent

- ID: M254669

- Name: Peginterferon alfa-2b

- Relevance: HIGH

- As Found: IDP-

- ID: M19243

- Name: Interferon-alpha

- Relevance: HIGH

- As Found: Status

- ID: M1685

- Name: Interferon alpha-2

- Relevance: HIGH

- As Found: Observation

- ID: M4314

- Name: Antiviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000007372

- Term: Interferons

- ID: D000016898

- Term: Interferon-alpha

- ID: D000077190

- Term: Interferon alpha-2

- ID: C000417083

- Term: Peginterferon alfa-2b

### Misc Info Module

- Version Holder: 2024-05-24
