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Completed

NCT Number: NCT00002779

Fludarabine Plus Octreotide in Treating Patients With 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fludarabine phosphate

Drug

octreotide acetate

Drug

Primary outcomes

  1. response rate

    Time frame: Up to 5 years

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
1998
Primary completion
2000
Study completion
2015
First posted
Jul 29, 2004
Registry last updated
Dec 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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