Fludarabine Plus Octreotide in Treating Patients With Relapsed Low-Grade Non-Hodgkin's Lymphoma
- Registration Number
- NCT00002779
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description fludarabine + octreotide octreotide acetate 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. fludarabine + octreotide fludarabine phosphate 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.
- Primary Outcome Measures
Name Time Method response rate Up to 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
Siouxland Hematology-Oncology
🇺🇸Sioux City, Iowa, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Quain & Ramstad Clinic, P.C.
🇺🇸Bismarck, North Dakota, United States
Saskatchewan Cancer Agency
🇨🇦Regina, Saskatchewan, Canada
CCOP - Geisinger Clinical and Medical Center
🇺🇸Danville, Pennsylvania, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
Altru Health Systems
🇺🇸Grand Forks, North Dakota, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States