PHASE II TRIAL OF FLUDARABINE AND SANDOSTATIN FOR RELAPSED LOW-GRADE NON-HODGKIN'S LYMPHOMA
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.
PROJECTED ACCRUAL: A total of 23-34 patients will be accrued for this study within 1.5
years.
Interventional
Primary Purpose: Treatment
Thomas E. Witzig, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000064787
NCT00002779
February 1998
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
CCOP - Duluth | Duluth, Minnesota 55805 |
CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
Quain & Ramstad Clinic, P.C. | Bismarck, North Dakota 58501 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
Altru Health Systems | Grand Forks, North Dakota 58201 |
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
CCOP - Geisinger Clinical and Medical Center | Danville, Pennsylvania 17822-2001 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |