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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00327600
Recruitment Status : Completed
First Posted : May 18, 2006
Last Update Posted : September 15, 2010
Information provided by:
AmpliMed Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Malignant Melanoma Drug: imexon Drug: DTIC Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: imexon + DTIC Drug: imexon
Drug: DTIC

Primary Outcome Measures :
  1. Determine the maximally tolerated dose of imexon plus DTIC
  2. determine the toxicity and tolerability of the combination
  3. determine response rate and progression free survival

Secondary Outcome Measures :
  1. Determine effects of the drug combination on plasma thiol levels and other biomarkers

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00327600

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
Study Director: Evan Hersh, MD AmpliMed Corporation

Publications of Results:
Responsible Party: Evan Hersh, VP Medical Affairs, AmpliMed Corporation Identifier: NCT00327600     History of Changes
Obsolete Identifiers: NCT00301132
Other Study ID Numbers: AMP-005
First Posted: May 18, 2006    Key Record Dates
Last Update Posted: September 15, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas