Study of Karenitecin (BNP1350) to Treat Malignant Melanoma

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of Karenitecin (BNP1350) as a treatment for Malignant Melanoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioNumerik Pharmaceuticals, Inc.
• Collaborator: Crown Bioscience
• Treatments: Camptothecin

Criteria

• Confirmed diagnosis of malignant melanoma

• Measurable disease

• Granulocytes ≥1,500/µl, Platelets ≥100,000/µl, Creatinine ≤ULN, Bilirubin ≤1.5 mg/dl, AST ≤2.5 x ULN

• No prior treatment with other camptothecin drug.

• ≥ 21 days since completion of prior chemotherapy, ≥6 weeks since prior Mitomycin-C

• ECOG Performance Status 0-1

• Negative pregnancy test for female patients