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

Sponsor
AmpliMed Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00327600
Collaborator
(none)
68
Enrollment
11
Locations
1
Arm
29
Duration (Months)
6.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1/Phase 2

Study Design

Study Type:
Interventional
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 :
Jul 1, 2005
Actual Primary Completion Date :
Jan 1, 2007
Actual Study Completion Date :
Dec 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: imexon + DTIC

Drug: imexon

Drug: DTIC

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Investigational Site 009 Los Angeles California United States 90033
2 Investigational Site 002 Santa Monica California United States 90404
3 University of CO Anschutz Cancer Pavilion Aurora Colorado United States 80010
4 US Oncology Orlando, Cancer Centers of FL Ocoee Florida United States 34761
5 US Oncology Albany, New York Oncology Albany New York United States 12208
6 US Oncology Kettering Kettering Ohio United States 45409
7 US Oncology Greenville, Cancer Centers of the Carolinas Greenville South Carolina United States 29615
8 US Oncology, Tyler Cancer Center Tyler Texas United States 75702
9 Investigational Site 012 Salt Lake City Utah United States 84112
10 US Oncology, Virginia Oncology Assoc Norfolk Virginia United States 23502
11 US Oncology Spokane, Cancer Care Northwest Spokane Washington United States 99218

Sponsors and Collaborators

  • AmpliMed Corporation

Investigators

  • Study Director: Evan Hersh, MD, AmpliMed Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00327600
Other Study ID Numbers:
  • AMP-005
  • NCT00301132
First Posted:
May 18, 2006
Last Update Posted:
Sep 15, 2010
Last Verified:
Sep 1, 2010
Additional relevant MeSH terms:
Melanoma

Study Results

No Results Posted as of Sep 15, 2010