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Completed

NCT Number: NCT00062491

Study of Karenitecin (BNP1350) to Treat Malignant Melanoma

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

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Key information

Conditions

Melanoma Neoplasm Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

For Information call 210-614-1701 for a site near you

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Karenitecin (BNP1350)

Drug

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 outcomes

  1. Overall Response

    Time frame: start of treatment until progressive disease

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

BioNumerik Pharmaceuticals, Inc.

Industry

Collaborators

  • Crown Bioscience

Registry information

Official study title

Phase 2 Trial of Karenitecin (BNP1350) in Patients With Malignant Melanoma

Important dates

Study start
2002
Primary completion
2003
Study completion
2005
First posted
Jun 12, 2003
Registry last updated
Mar 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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