Clinical trial · Interventional
Fludarabine Plus Octreotide in Treating Patients With Relapsed Low-Grade Non-Hodgkin's Lymphoma
PHASE II TRIAL OF FLUDARABINE AND SANDOSTATIN FOR RELAPSED LOW-GRADE NON-HODGKIN'S LYMPHOMA
NCT00002779CI-TRIAL-00025185completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| octreotide acetate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- fludarabine + octreotide
- description
- 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.
- interventionNames
- Drug: fludarabine phosphate
- Drug: octreotide acetate
Primary outcomes (1)
- measure
- response rate
- timeFrame
- Up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.