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Home > "I" Clinical Trials Conditions > Irinotecan in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma  Irinotecan in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma
Irinotecan in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma
For Condition: Lymphocytic Lymphoma,Myeloid Leukemia,Burkitt's Lymphoma,Plasma Cell Tumors
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , M.D. Anderson Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients with recurrent or refractory non-Hodgkin's lymphoma.
Details: OBJECTIVES: I. Determine the objective response rate and toxicity of irinotecan when administered to patients with recurrent or refractory non-Hodgkin's lymphoma. PROTOCOL OUTLINE: Patients are stratified by disease category (aggressive vs indolent vs mantle cell lymphoma). Patients with aggressive and indolent lymphoma are further stratified as to being refractory (no complete response (CR) or partial response (PR) to initial therapy) vs recurrent (CR or PR to initial therapy); i.e, the following subcategories are used: Stratum I: refractory aggressive non-Hodgkin's lymphoma (NHL) Stratum II: recurrent aggressive NHL Stratum III: refractory indolent NHL Stratum IV: recurrent indolent NHL Stratum V: mantle cell NHL All patients receive irinotecan intravenously every 21 days. Patients achieving CR or PR receive 6 courses. Patients may receive bone marrow transplantation after at least 2 courses. Patients are followed every 3 months for survival. PROJECTED ACCRUAL: This study will accrue 18 patients per stratum; if at least three patients respond, an additional 25 patients will be accrued for a total of 43 evaluable patients per stratum. The total number accrued will be 90-215 over a period of approximately 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/75 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed recurrent or refractory non-Hodgkin's lymphoma; First relapse requires histologic confirmation of relapse - No CNS metastases - No lymphomatous meningitis - Measurable disease --Prior/Concurrent Therapy-- - Biologic therapy: No prior bone marrow transplantation - Chemotherapy: No more than 2 prior chemotherapy regimens for treatment of lymphoma; No prior irinotecan, topotecan or aminocamptothecin; At least 3 weeks since prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: At least 3 weeks since prior radiotherapy; Radiotherapy that is not a part of a combined-modality therapy is counted as a regimen (see Chemotherapy) - Surgery: Not specified - Other: No phenytoin, phenobarbital, or other antiepileptic prophylaxis --Patient Characteristics-- - Age: 15-75 - Performance status: Zubrod 0-2 - Life expectancy: At least 12 weeks - Hematopoietic: Unless due to lymphoma: Platelet count at least 100,000/mm3; Absolute granulocyte count at least 1,500/mm3; Hemoglobin at least 9 g/dL - Hepatic: Bilirubin no greater than 1.5 mg/dL; SGOT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if liver involvement) - Renal: Creatinine no greater than 2.0 mg/dL; Baseline calcium less than 12 mg/dL - Cardiovascular: No myocardial infarction within 6 months; No congestive heart failure requiring therapy - Other: No history of seizures; No uncontrolled diabetes mellitus (i.e., random blood sugar of at least 250 mg); No other concurrent severe disease; No uncontrolled infection; HIV negative; No psychoses; No prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cancer of the cervix unless surgically treated and disease free for at least 5 years; Not pregnant or lactating; Effective contraception required of fertile patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AndreGoy, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Additional Information:
Study ID Numbers: CDR0000066124; MDA-DM-97182,NCI-T97-0103
Study Start Date: February 1998
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003245
Other Lymphocytic Lymphoma Studies:
1. HLA-Mismatched Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Hematological Malignancies
2. Irinotecan and Cytarabine in Treating Patients With Refractory or Recurrent Acute Myeloid Leukemia or Chronic Myelogenous Leukemia
3. Tipifarnib in Treating Patients With Advanced Hematologic Cancer
4. Comparison of Three Treatment Regimens in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia
5. Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults
Related Studies:
Other Lymphocytic Lymphoma Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Irinotecan in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma
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