Phase II Study of Irinotecan for the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
irinotecan hydrochloride
Blood Protein Disorders+36
+ Cardiovascular Diseases
+ Chronic Disease
Treatment Study
Summary
Study start date: February 18, 1998
Actual date on which the first participant was enrolled.OBJECTIVES: Determine the objective response rate and toxicity of irinotecan when administered to patients with recurrent or refractory non-Hodgkin's lymphoma. 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 15 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 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/mm^3 Absolute granulocyte count at least 1,500/mm^3 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 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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Texas - MD Anderson Cancer Center
Houston, United StatesOpen University of Texas - MD Anderson Cancer Center in Google Maps