NCT00002779

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Lymphoma

Interventions

Type	Name	Description
DRUG	fludarabine phosphate
DRUG	octreotide acetate

Timeline

• Start date: 1998-02-01
• Primary completion: 2000-07-01
• Completion: 2015-06-01
• First posted: 2004-07-29
• Last updated: 2016-12-15

Locations

20 sites across 2 countries: United States, Canada