Study of Karenitecin (BNP1350) to Treat Malignant Melanoma

This study has been completed.
Sponsor:
Information provided by:
BioNumerik Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00062491
First received: June 6, 2003
Last updated: April 1, 2009
Last verified: April 2009
  Purpose

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


Condition Intervention Phase
Melanoma
Neoplasm
Drug: Karenitecin (BNP1350)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Trial of Karenitecin (BNP1350) in Patients With Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by BioNumerik Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Overall Response [ Time Frame: start of treatment until progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective Tumor Response Rate [ Time Frame: Start of treatment to date of response ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: Date of response to date of progressive disease ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Randomization to date of death from any cause ] [ Designated as safety issue: No ]
  • Progression Free Survival [ Time Frame: Randomization to disease progression ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: May 2002
Study Completion Date: November 2005
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062491

Locations
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.
  More Information

No publications provided

Responsible Party: BioNumerik (Chief Executive Officer), BioNumerik
ClinicalTrials.gov Identifier: NCT00062491     History of Changes
Other Study ID Numbers: KTN23106
Study First Received: June 6, 2003
Last Updated: April 1, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 22, 2014