Overview

Nitrocamptothecin in Treating Patients With Metastatic Melanoma

Status:
Completed
Trial end date:
2004-04-01
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. PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have metastatic melanoma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Astex Pharmaceuticals
Astex Pharmaceuticals, Inc.
Treatments:
Rubitecan
Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic melanoma
Choroidal (no prior chemotherapy required) OR Nonchoroidal No more than 3 chemotherapy
regimens Bidimensionally measurable disease No symptomatic uncontrolled CNS involvement
including extensive brain metastases, spinal cord compression, or meningeal carcinomatosis
Not eligible for treatment protocol of higher priority

PATIENT CHARACTERISTICS: Age: Over 16 Performance status: Zubrod 0-2 Life expectancy:
Greater than 8 weeks Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet
count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of
normal (ULN) Transaminase no greater than 3 times ULN Renal: Creatinine no greater than 2.0
mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception during and for 1 year after study No serious concurrent illness

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics At least 3 weeks since prior chemotherapy and recovered Endocrine therapy:
Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered
Surgery: Not specified