## Protocol Section
### Identification Module
**NCT ID:** NCT00002779

**Brief Title:** Fludarabine Plus Octreotide in Treating Patients With Relapsed Low-Grade Non-Hodgkin's Lymphoma

**Official Title:** PHASE II TRIAL OF FLUDARABINE AND SANDOSTATIN FOR RELAPSED LOW-GRADE NON-HODGKIN'S LYMPHOMA

#### Organization Study ID Info
**ID:** NCCTG-947851
#### Organization
**Class:** OTHER
**Full Name:** Alliance for Clinical Trials in Oncology
#### Secondary ID Infos
**ID:** NCCTG-947851
**Domain:** NCI Physician Data Query
**ID:** CDR0000064787
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2015-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-12-15

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-12-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2000-07

**Type:** ACTUAL

#### Start Date
**Date:** 1998-02

**Status Verified Date:** 2016-12

#### Study First Post Date
**Date:** 2004-07-29
**Type:** ESTIMATED
**Study First Submit Date:** 1999-11-01
**Study First Submit QC Date:** 2004-07-28
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

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

#### Lead Sponsor

**Class:** OTHER

**Name:** Alliance for Clinical Trials in Oncology

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** RATIONALE: Drugs used in chemotherapy and hormone therapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of fludarabine plus octreotide in treating patients who have relapsed low-grade non-Hodgkin's lymphoma.

**Detailed Description:** OBJECTIVES: I. Determine the response rate and duration of response to fludarabine combined with octreotide and to octreotide alone in patients with relapsed indolent non-Hodgkin's lymphoma. II. Determine serum insulin-like growth factor-1 (IGF-1) and IGF-1 binding protein levels before and after treatment in this patient population. III. Determine somatostatin receptor subtypes in lymphoma biopsy samples from selected patients.

OUTLINE: Patients receive fludarabine IV over 10-30 minutes on days 1-5. Patients not currently receiving octreotide, receive a test dose of octreotide subcutaneously on day 1 during course 1 only and then receive octreotide intramuscularly monthly on day 1. Treatment repeats every 28 days for 4-6 courses. Patients then receive octreotide alone for 6-8 courses. Some patients may then receive another 12 courses of octreotide alone, for a total of 2 years of treatment. Patients are followed every 3 months for 5 years or until disease progression.

### Conditions Module

**Conditions:**

- Lymphoma

**Keywords:**

- Waldenström macroglobulinemia

- recurrent small lymphocytic lymphoma

- recurrent grade 1 follicular lymphoma

- recurrent grade 2 follicular lymphoma

- recurrent mantle cell lymphoma

- recurrent marginal zone lymphoma

- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue

- nodal marginal zone B-cell lymphoma

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 34

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients receive fludarabine IV over 10-30 minutes on days 1-5. Patients not currently receiving octreotide, receive a test dose of octreotide subcutaneously on day 1 during course 1 only and then receive octreotide intramuscularly monthly on day 1. Treatment repeats every 28 days for 4-6 courses. Patients then receive octreotide alone for 6-8 courses. Some patients may then receive another 12 courses of octreotide alone, for a total of 2 years of treatment. Patients are followed every 3 months for 5 years or until disease progression.

**Intervention Names:**

- Drug: fludarabine phosphate

- Drug: octreotide acetate

**Label:** fludarabine + octreotide

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- fludarabine + octreotide

**Name:** fludarabine phosphate

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- fludarabine + octreotide

**Name:** octreotide acetate

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** response rate

**Time Frame:** Up to 5 years

### Eligibility Module

**Eligibility Criteria:** DISEASE CHARACTERISTICS: Histologically diagnosed indolent non-Hodgkin's lymphoma (NHL) of 1 of the following types: Diffuse small lymphocytic cell Follicular small cleaved cell Follicular mixed small and large cleaved cell Mantle cell lymphoma/leukemia (intermediate differentiated lymphoma) Preferentially treated on protocol NCCTG-958053 when available Monocytoid B-cell Mucosa-associated lymphoid tissue (MALT) Lymphoplasmacytic lymphoma (Waldenstrom's macroglobulinemia) Histology documented by lymph node (or other mass) or bone marrow biopsy within 6 months prior to entry Relapsed after cytotoxic chemotherapy regimens At least 1 measurable lesion by palpation, chest x-ray, CT, or MRI, e.g.: Lymph node at least 1.5 x 1.5 cm by palpation Spleen at least 3 cm below left costal margin The following exclude: CNS involvement by positive CSF cytology or CT/MRI B- or T-cell chronic lymphocytic leukemia Hairy cell leukemia Mycosis fungoides Aggressive lymphoma

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Total bilirubin no greater than 2 times normal OR Direct bilirubin no greater than 1.0 mg/dL above normal Renal: Creatinine no greater than 2.0 times normal Cardiovascular: No uncontrolled congestive heart failure No uncontrolled hypertension No uncontrolled angina pectoris Other: No uncontrolled or active infection No AIDS or HIV antibody No second malignancy within 5 years except: Carcinoma in situ of the cervix Resected nonmelanomatous skin cancer Prostate cancer in remission following radical retropubic prostatectomy or radiotherapy Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Recovered from toxic effects of prior therapy Biologic therapy: See Disease Characteristics No concurrent interferon Chemotherapy: See Disease Characteristics No prior purine nucleoside analogues (e.g., fludarabine, pentostatin, or 2- chlorodeoxyadenosine) At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas) No other concurrent cytotoxic chemotherapy Endocrine therapy: No prior octreotide for lymphoma No concurrent corticosteriods except for Addison's disease Radiotherapy: Not specified Surgery: Not specified Other: No other concurrent investigational drugs

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Scottsdale

**Country:** United States

**Facility:** CCOP - Scottsdale Oncology Program

**State:** Arizona

**Zip:** 85259-5404

**Location 2:**

**City:** Peoria

**Country:** United States

**Facility:** CCOP - Illinois Oncology Research Association

**State:** Illinois

**Zip:** 61602

**Location 3:**

**City:** Urbana

**Country:** United States

**Facility:** CCOP - Carle Cancer Center

**State:** Illinois

**Zip:** 61801

**Location 4:**

**City:** Cedar Rapids

**Country:** United States

**Facility:** CCOP - Cedar Rapids Oncology Project

**State:** Iowa

**Zip:** 52403-1206

**Location 5:**

**City:** Des Moines

**Country:** United States

**Facility:** CCOP - Iowa Oncology Research Association

**State:** Iowa

**Zip:** 10309-1016

**Location 6:**

**City:** Sioux City

**Country:** United States

**Facility:** Siouxland Hematology-Oncology

**State:** Iowa

**Zip:** 51101-1733

**Location 7:**

**City:** Wichita

**Country:** United States

**Facility:** CCOP - Wichita

**State:** Kansas

**Zip:** 67214-3882

**Location 8:**

**City:** New Orleans

**Country:** United States

**Facility:** CCOP - Ochsner

**State:** Louisiana

**Zip:** 70121

**Location 9:**

**City:** Duluth

**Country:** United States

**Facility:** CCOP - Duluth

**State:** Minnesota

**Zip:** 55805

**Location 10:**

**City:** Rochester

**Country:** United States

**Facility:** Mayo Clinic Cancer Center

**State:** Minnesota

**Zip:** 55905

**Location 11:**

**City:** Saint Louis Park

**Country:** United States

**Facility:** CCOP - Metro-Minnesota

**State:** Minnesota

**Zip:** 55416

**Location 12:**

**City:** Omaha

**Country:** United States

**Facility:** CCOP - Missouri Valley Cancer Consortium

**State:** Nebraska

**Zip:** 68131

**Location 13:**

**City:** Bismarck

**Country:** United States

**Facility:** Quain & Ramstad Clinic, P.C.

**State:** North Dakota

**Zip:** 58501

**Location 14:**

**City:** Fargo

**Country:** United States

**Facility:** CCOP - Merit Care Hospital

**State:** North Dakota

**Zip:** 58122

**Location 15:**

**City:** Grand Forks

**Country:** United States

**Facility:** Altru Health Systems

**State:** North Dakota

**Zip:** 58201

**Location 16:**

**City:** Toledo

**Country:** United States

**Facility:** CCOP - Toledo Community Hospital Oncology Program

**State:** Ohio

**Zip:** 43623-3456

**Location 17:**

**City:** Danville

**Country:** United States

**Facility:** CCOP - Geisinger Clinical and Medical Center

**State:** Pennsylvania

**Zip:** 17822-2001

**Location 18:**

**City:** Rapid City

**Country:** United States

**Facility:** Rapid City Regional Hospital

**State:** South Dakota

**Zip:** 57709

**Location 19:**

**City:** Sioux Falls

**Country:** United States

**Facility:** CCOP - Sioux Community Cancer Consortium

**State:** South Dakota

**Zip:** 57105-1080

**Location 20:**

**City:** Regina

**Country:** Canada

**Facility:** Saskatchewan Cancer Agency

**State:** Saskatchewan

**Zip:** S4S 6X3

#### Overall Officials

**Official 1:**

**Affiliation:** Mayo Clinic

**Name:** Thomas E. Witzig, MD

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M18116

- Name: Leukemia, Lymphocytic, Chronic, B-Cell

- Relevance: LOW

- As Found: Unknown

- ID: M11220

- Name: Lymphoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: M22307

- Name: Lymphoma, Mantle-Cell

- Relevance: LOW

- As Found: Unknown

- ID: M11221

- Name: Lymphoma, Follicular

- Relevance: LOW

- As Found: Unknown

- ID: M20554

- Name: Lymphoma, B-Cell, Marginal Zone

- Relevance: LOW

- As Found: Unknown

- ID: M14850

- Name: Recurrence

- Relevance: LOW

- As Found: Unknown

- ID: M18828

- Name: Lymphoma, B-Cell

- Relevance: LOW

- As Found: Unknown

- ID: M11251

- Name: Waldenstrom Macroglobulinemia

- Relevance: LOW

- As Found: Unknown

- ID: M11222

- Name: Lymphoma, Non-Hodgkin

- Relevance: HIGH

- As Found: Non-Hodgkin Lymphoma

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10206

- Name: Immunoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1308

- Name: Chronic Lymphocytic Leukemia

- Relevance: LOW

- As Found: Unknown

- ID: T3543

- Name: Lymphosarcoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: T3601

- Name: Mantle Cell Lymphoma

- Relevance: LOW

- As Found: Unknown

- ID: T2361

- Name: Follicular Lymphoma

- Relevance: LOW

- As Found: Unknown

- ID: T640

- Name: B-cell Lymphoma

- Relevance: LOW

- As Found: Unknown

- ID: T3612

- Name: Marginal Zone Lymphoma

- Relevance: LOW

- As Found: Unknown

- ID: T5887

- Name: Waldenstrom Macroglobulinemia

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008223

- Term: Lymphoma

- ID: D000008228

- Term: Lymphoma, Non-Hodgkin

### Intervention Browse Module - Ancestors

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000000964

- Term: Antimetabolites, Antineoplastic

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000007166

- Term: Immunosuppressive Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000018931

- Term: Antineoplastic Agents, Hormonal

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M283230

- Name: Fludarabine

- Relevance: HIGH

- As Found: Comparison

- ID: M225513

- Name: Fludarabine phosphate

- Relevance: HIGH

- As Found: Intubation

- ID: M17982

- Name: Octreotide

- Relevance: HIGH

- As Found: Poorly

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20966

- Name: Antineoplastic Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000024352

- Term: Fludarabine

- ID: C000042382

- Term: Fludarabine phosphate

- ID: D000015282

- Term: Octreotide

### Misc Info Module

- Version Holder: 2024-05-24
