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



Status:Completed
Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/16/2016
Start Date:February 1998
End Date:June 2015

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

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.

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.

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
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300 East Locust St., Ste 350
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353 Fairmont Blvd
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509 W. University Avenue
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Wichita, Kansas 67214
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