Overview

Irinotecan in Treating Patients With Solid Tumors or Lymphoma Who Have Abnormal Liver or Kidney Function or Who Have Received Radiation Therapy to the Pelvis

Status:
Completed
Trial end date:
2006-07-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Irinotecan may be effective in treating patients with abnormal liver or kidney function or who have received radiation therapy. PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating patients with solid tumors or lymphoma who have abnormal liver or kidney function or who have had previous radiation therapy to the pelvis.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute (NCI)
Collaborator:
Alliance for Clinical Trials in Oncology
Treatments:
Camptothecin
Irinotecan
Criteria
DISEASE CHARACTERISTICS: Histologically proven solid tumors or lymphoma refractory to
standard therapy or for which no standard therapy exists Brain metastases allowed if
following criteria met: Asymptomatic Received prior therapy for brain metastases Stable for
at least 2 months No concurrent steroid therapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CALGB 0-2 Life expectancy:
Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hepatic and Renal: Albumin at least 2.5 g/dL Prothrombin time less than 1.6 For
patients without prior pelvic radiotherapy: AST at least 3 times upper limit of normal
(ULN) OR Bilirubin 1.0 - 7.0 mg/dL with any AST OR Creatinine 1.6 - 5.0 mg/dL For patients
with prior pelvic radiotherapy: AST less than 3 times ULN AND Bilirubin less than 1.0 mg/dL
AND Creatinine less than 1.6 mg/dL Other: Not pregnant or nursing

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factors
Chemotherapy: At least 4 weeks since prior chemotherapy (at least 6 weeks since melphalan
or mitomycin) At least 3 months since suramin No prior nitrosoureas or irinotecan Endocrine
therapy: No concurrent steroids (except as antiemetic for chemotherapy) Radiotherapy: At
least 4 weeks since prior radiotherapy Surgery: At least 4 weeks since major surgery Other:
No concurrent medications known to affect hepatic or renal function (e.g., antiseizure
medication or nonsteroidal antiinflammatory drugs)