Study of Karenitecin (BNP1350) to Treat Malignant Melanoma - Full Text View

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Karenitecin

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

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

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on November 27, 2009