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

September 14, 2010 updated by: AmpliMed Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Investigational Site 009
      • Santa Monica, California, United States, 90404
        • Investigational Site 002
    • Colorado
      • Aurora, Colorado, United States, 80010
        • University of CO Anschutz Cancer Pavilion
    • Florida
      • Ocoee, Florida, United States, 34761
        • US Oncology Orlando, Cancer Centers of FL
    • New York
      • Albany, New York, United States, 12208
        • US Oncology Albany, New York Oncology
    • Ohio
      • Kettering, Ohio, United States, 45409
        • US Oncology Kettering
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • US Oncology Greenville, Cancer Centers of the Carolinas
    • Texas
      • Tyler, Texas, United States, 75702
        • US Oncology, Tyler Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Investigational site 012
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • US Oncology, Virginia Oncology Assoc
    • Washington
      • Spokane, Washington, United States, 99218
        • US Oncology Spokane, Cancer Care Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: imexon + DTIC
Drug: imexon
Drug: DTIC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Determine the maximally tolerated dose of imexon plus DTIC
determine the toxicity and tolerability of the combination
determine response rate and progression free survival

Secondary Outcome Measures

Outcome Measure
Determine effects of the drug combination on plasma thiol levels and other biomarkers

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AmpliMed Corporation

Investigators

  • Study Director: Evan Hersh, MD, AmpliMed Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

May 17, 2006

First Submitted That Met QC Criteria

May 17, 2006

First Posted (Estimate)

May 18, 2006

Study Record Updates

Last Update Posted (Estimate)

September 15, 2010

Last Update Submitted That Met QC Criteria

September 14, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMP-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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