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Safety and Efficacy Trial of Imexon Plus DTIC in Advanced Malignant Melanoma

This study has been completed.
Sponsor:
Information provided by:
AmpliMed Corporation
ClinicalTrials.gov Identifier:
NCT00327600
First received: May 17, 2006
Last updated: September 14, 2010
Last verified: September 2010
History of Changes
  Purpose

AMP-005 is a Phase 1b/2 clinical trial designed to evaluate whether the new drug, imexon, can be administered in combination with the approved drug, dacarbazine (DTIC), for the treatment of patients with stage III or IV inoperable melanoma. The Phase 1b part of the study is designed to determine whether the two drugs can be safely combined together, and the Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether adding imexon to DTIC can improve the outcome for melanoma patients versus the findings from prior clinical studies of DTIC alone.


Condition Intervention Phase
Malignant Melanoma
 Drug: imexon
Drug: DTIC
 Phase 1
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: A Phase 1/2 Trial of Amplimexon® (Imexon, Inj.) Plus Dacarbazine (DTIC) in Chemotherapy Naive Patients With Unresectable Stage III or Stage IV Malignant Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Melanoma
Drug Information available for: Dacarbazine
U.S. FDA Resources

Further study details as provided by AmpliMed Corporation:

Primary Outcome Measures:
  • Determine the maximally tolerated dose of imexon plus DTIC [ Designated as safety issue: Yes ]
  • determine the toxicity and tolerability of the combination [ Designated as safety issue: Yes ]
  • determine response rate and progression free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine effects of the drug combination on plasma thiol levels and other biomarkers [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: July 2005
Study Completion Date: December 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: imexon + DTIC Drug: imexon Drug: DTIC

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Malignant melanoma; inoperable stage III or IV disease.
  • Able to perform the activities of daily living.
  • A projected life expectancy of at least 4 months.
  • If female, neither pregnant nor nursing.
  • Willing to use contraceptives to prevent pregnancy.
  • Blood cell counts and blood chemistries in or near normal range.
  • Prior radiation is permitted.
  • No other serious illnesses.
  • No other active malignancy.
  • No serious infections.
  • No other current drug therapy for the cancer or steroid therapy.

Exclusion Criteria:

  • No prior chemotherapy for the stage III or IV disease.
  • Brain metastases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00327600

Locations
United States, California
Investigational Site 009
Los Angeles, California, United States, 90033
Investigational Site 002
Santa Monica, California, United States, 90404
United States, Colorado
University of CO Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80010
United States, Florida
US Oncology Orlando, Cancer Centers of FL
Ocoee, Florida, United States, 34761
United States, New York
US Oncology Albany, New York Oncology
Albany, New York, United States, 12208
United States, Ohio
US Oncology Kettering
Kettering, Ohio, United States, 45409
United States, South Carolina
US Oncology Greenville, Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29615
United States, Texas
US Oncology, Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Utah
Investigational Site 012
Salt Lake City, Utah, United States, 84112
United States, Virginia
US Oncology, Virginia Oncology Assoc
Norfolk, Virginia, United States, 23502
United States, Washington
US Oncology Spokane, Cancer Care Northwest
Spokane, Washington, United States, 99218
Sponsors and Collaborators
AmpliMed Corporation
Investigators
Study Director: Evan Hersh, MD AmpliMed Corporation
  More Information

Publications:

Responsible Party: Evan Hersh, VP Medical Affairs, AmpliMed Corporation
ClinicalTrials.gov Identifier: NCT00327600     History of Changes
Obsolete Identifiers: NCT00301132
Other Study ID Numbers: AMP-005
Study First Received: May 17, 2006
Last Updated: September 14, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 17, 2013