Study of Karenitecin (BNP1350) to Treat Malignant Melanoma

• Sponsor: BioNumerik Pharmaceuticals, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00062491
• Collaborator: Crown Bioscience (Industry)
• Enrollment: 46
• Location: 1
• Arm: 1
• Duration (Months): 42.1
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Melanoma; Neoplasm	Drug: Karenitecin (BNP1350)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 2 Trial of Karenitecin (BNP1350) in Patients With Malignant Melanoma
• Study Start Date: May 1, 2002
• Actual Primary Completion Date: Jun 1, 2003
• Actual Study Completion Date: Nov 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Karenitecin (BNP1350)	Drug: Karenitecin (BNP1350); 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.

Outcome Measures

Primary Outcome Measures

1. Overall Response [start of treatment until progressive disease]

Secondary Outcome Measures

1. Objective Tumor Response Rate [Start of treatment to date of response]

2. Duration of Response [Date of response to date of progressive disease]

3. Overall Survival [Randomization to date of death from any cause]

4. Progression Free Survival [Randomization to disease progression]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	For Information call 210-614-1701 for a site near you	Tampa	Florida	United States	33612

Sponsors and Collaborators

• BioNumerik Pharmaceuticals, Inc.
• Crown Bioscience

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: BioNumerik Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT00062491
• Other Study ID Numbers: KTN23106
• First Posted: Jun 12, 2003
• Last Update Posted: Mar 12, 2020
• Last Verified: Mar 1, 2020

• Additional relevant MeSH terms: Melanoma

Study Results

No Results Posted as of Mar 12, 2020