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Study of Karenitecin (BNP1350) to Treat Malignant Melanoma

This study has been completed.

Sponsored by: BioNumerik Pharmaceuticals, Inc.
Information provided by: BioNumerik Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00062491
  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 II

MedlinePlus related topics:   Cancer    Melanoma   

Drug Information available for:   Karenitecin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Phase 2 Trial of Karenitecin (BNP1350) in Patients With Malignant Melanoma

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
1: Experimental
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


Responsible Party:   BioNumerik ( BioNumerik (Chief Executive Officer) )
Study ID Numbers:   KTN23106
First Received:   June 6, 2003
Last Updated:   May 6, 2008
ClinicalTrials.gov Identifier:   NCT00062491
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 30, 2008




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