Study of Karenitecin (BNP1350) to Treat Malignant Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00062491
Recruitment Status : Completed
First Posted : June 12, 2003
Last Update Posted : October 23, 2018
Information provided by (Responsible Party):
BioNumerik Pharmaceuticals, Inc.

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 Type : Interventional  (Clinical Trial)
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 2002
Actual Primary Completion Date : June 2003
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

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.

Primary Outcome Measures :
  1. Overall Response [ Time Frame: start of treatment until progressive disease ]

Secondary Outcome Measures :
  1. Objective Tumor Response Rate [ Time Frame: Start of treatment to date of response ]
  2. Duration of Response [ Time Frame: Date of response to date of progressive disease ]
  3. Overall Survival [ Time Frame: Randomization to date of death from any cause ]
  4. Progression Free Survival [ Time Frame: Randomization to disease progression ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00062491

United States, Florida
For Information call 210-614-1701 for a site near you
Tampa, Florida, United States, 33612
Sponsors and Collaborators
BioNumerik Pharmaceuticals, Inc.

Responsible Party: BioNumerik Pharmaceuticals, Inc. Identifier: NCT00062491     History of Changes
Other Study ID Numbers: KTN23106
First Posted: June 12, 2003    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action