Clinical trial NCT00002779: Fludarabine Plus Octreotide in Treating Patients With Relapsed Low-Grade Non-Hodgkin's Lymphoma
Official title: PHASE II TRIAL OF FLUDARABINE AND SANDOSTATIN FOR RELAPSED LOW-GRADE NON-HODGKIN'S LYMPHOMA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: Waldenström macroglobulinemia
recurrent small lymphocytic lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-07-29
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

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

Primary outcomes:
measure: response rate
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: CCOP - Scottsdale Oncology Program
state: Arizona
city: Peoria
country: United States
facility: CCOP - Illinois Oncology Research Association
state: Illinois
city: Urbana
country: United States
facility: CCOP - Carle Cancer Center
state: Illinois
city: Cedar Rapids
country: United States
facility: CCOP - Cedar Rapids Oncology Project
state: Iowa
city: Des Moines
country: United States
facility: CCOP - Iowa Oncology Research Association
state: Iowa
city: Sioux City
country: United States
facility: Siouxland Hematology-Oncology
state: Iowa
city: Wichita
country: United States
facility: CCOP - Wichita
state: Kansas
city: New Orleans
country: United States
facility: CCOP - Ochsner
state: Louisiana
city: Duluth
country: United States
facility: CCOP - Duluth
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Saint Louis Park
country: United States
facility: CCOP - Metro-Minnesota
state: Minnesota
city: Omaha
country: United States
facility: CCOP - Missouri Valley Cancer Consortium
state: Nebraska
city: Bismarck
country: United States
facility: Quain & Ramstad Clinic, P.C.
state: North Dakota
city: Fargo
country: United States
facility: CCOP - Merit Care Hospital
state: North Dakota
city: Grand Forks
country: United States
facility: Altru Health Systems
state: North Dakota
city: Toledo
country: United States
facility: CCOP - Toledo Community Hospital Oncology Program
state: Ohio
city: Danville
country: United States
facility: CCOP - Geisinger Clinical and Medical Center
state: Pennsylvania
city: Rapid City
country: United States
facility: Rapid City Regional Hospital
state: South Dakota
city: Sioux Falls
country: United States
facility: CCOP - Sioux Community Cancer Consortium
state: South Dakota
city: Regina
country: Canada
facility: Saskatchewan Cancer Agency
state: Saskatchewan
Study officials:
affiliation: Mayo Clinic
name: Thomas E. Witzig, MD
role: STUDY_CHAIR
References: