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.

Condition	Treatment or Intervention	Phase
Lymphoma Lymphoma, Small Lymphocytic Lymphoma, Mantle-Cell Waldenstrom's Macroglobulinemia Lymphoma, Mucosa-Associated Lymphoid Tissue	Drug: fludarabine  Drug: octreotide	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

Arizona
      CCOP - Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61602,  United States
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  10309-1016,  United States
      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
Louisiana
      CCOP - Ochsner, New Orleans,  Louisiana,  70121,  United States
Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68131,  United States
North Dakota
      Altru Health Systems, Grand Forks,  North Dakota,  58201,  United States
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States
      Quain & Ramstad Clinic, P.C., Bismarck,  North Dakota,  58501,  United States
Ohio
      CCOP - Toledo Community Hospital Oncology Program, Toledo,  Ohio,  43623-3456,  United States
Pennsylvania
      CCOP - Geisinger Clinical and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57105-1080,  United States
      Rapid City Regional Hospital, Rapid City,  South Dakota,  57709,  United States
Canada, Saskatchewan
      Saskatchewan Cancer Agency, Regina,  Saskatchewan,  S4S 6X3,  Canada

Study chairs or principal investigators

Thomas E. Witzig,  Study Chair,  North Central Cancer Treatment Group   

Study ID Numbers:  CDR0000064787; NCCTG-947851
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002779
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08