Melanoma, Neoplasm
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of Karenitecin (BNP1350) as a treatment for Malignant Melanoma.
Interventions
Karenitecn (1.0 mg/m2) administered as a single daily 60-minute intravenous infusion for 5 consecutive days repeated every 21 days (1 treatment cycle). Patients who respond (CR\< PR, SD) can continue treatment for 6 cycles, unless unacceptable toxicity develops. Treatment will be discontinued if progressive disease or unacceptable toxicity develops.
Sponsors
Crown Bioscience
BioNumerik Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response | start of treatment until progressive disease |
Secondary
| Measure | Time frame |
|---|---|
| Objective Tumor Response Rate | Start of treatment to date of response |
| Duration of Response | Date of response to date of progressive disease |
| Overall Survival | Randomization to date of death from any cause |
| Progression Free Survival | Randomization to disease progression |
Countries
United States
Outcome results
None listed