Overview
Irinotecan in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma
Status:
Completed
Completed
Trial end date:
2004-07-30
2004-07-30
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
M.D. Anderson Cancer CenterCollaborator:
National Cancer Institute (NCI)Treatments:
Camptothecin
Irinotecan
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