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NCT00327600 Clinical Trial

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

Malignant Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00327600
Other study ID # AMP-005
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received May 17, 2006
Last updated September 14, 2010
Start date July 2005
Est. completion date December 2007

Study information
Verified date September 2010
Source AmpliMed Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Other known NCT identifiers
  • NCT00301132

Recruitment information / eligibility
Status Completed
Enrollment 68
Est. completion date December 2007
Est. primary completion date January 2007
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• imexon

• DTIC

Locations
Country Name City State
United States US Oncology Albany, New York Oncology Albany New York
United States University of CO Anschutz Cancer Pavilion Aurora Colorado
United States US Oncology Greenville, Cancer Centers of the Carolinas Greenville South Carolina
United States US Oncology Kettering Kettering Ohio
United States Investigational Site 009 Los Angeles California
United States US Oncology, Virginia Oncology Assoc Norfolk Virginia
United States US Oncology Orlando, Cancer Centers of FL Ocoee Florida
United States Investigational Site 012 Salt Lake City Utah
United States Investigational Site 002 Santa Monica California
United States US Oncology Spokane, Cancer Care Northwest Spokane Washington
United States US Oncology, Tyler Cancer Center Tyler Texas

Sponsors (1)
Lead Sponsor Collaborator
AmpliMed Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Weber JS, Samlowski WE, Gonzalez R, Ribas A, Stephenson J, O'Day S, Sato T, Dorr R, Grenier K, Hersh E. A phase 1-2 study of imexon plus dacarbazine in patients with unresectable metastatic melanoma. Cancer. 2010 Aug 1;116(15):3683-91. doi: 10.1002/cncr.2 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Determine the maximally tolerated dose of imexon plus DTIC Yes
Primary determine the toxicity and tolerability of the combination Yes
Primary determine response rate and progression free survival No
Secondary Determine effects of the drug combination on plasma thiol levels and other biomarkers No
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