Back to resultsSafety and Efficacy Trial of Imexon Plus DTIC in Advanced Malignant Melanoma
Primary Purpose
Malignant Melanoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
imexon
DTIC
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Melanoma
Eligibility 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
Sites / Locations
- Investigational Site 009
- Investigational Site 002
- University of CO Anschutz Cancer Pavilion
- US Oncology Orlando, Cancer Centers of FL
- US Oncology Albany, New York Oncology
- US Oncology Kettering
- US Oncology Greenville, Cancer Centers of the Carolinas
- US Oncology, Tyler Cancer Center
- Investigational Site 012
- US Oncology, Virginia Oncology Assoc
- US Oncology Spokane, Cancer Care Northwest
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
imexon + DTIC
Arm Description
Outcomes
Primary Outcome Measures
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
Determine effects of the drug combination on plasma thiol levels and other biomarkers
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00327600
Brief Title
Safety and Efficacy Trial of Imexon Plus DTIC in Advanced Malignant Melanoma
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 Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AmpliMed Corporation
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
imexon + DTIC
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
imexon
Intervention Type
Drug
Intervention Name(s)
DTIC
Primary Outcome Measure Information:
Title
Determine the maximally tolerated dose of imexon plus DTIC
Title
determine the toxicity and tolerability of the combination
Title
determine response rate and progression free survival
Secondary Outcome Measure Information:
Title
Determine effects of the drug combination on plasma thiol levels and other biomarkers
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evan Hersh, MD
Organizational Affiliation
AmpliMed Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site 009
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Investigational Site 002
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
University of CO Anschutz Cancer Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
US Oncology Orlando, Cancer Centers of FL
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
US Oncology Albany, New York Oncology
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
US Oncology Kettering
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
US Oncology Greenville, Cancer Centers of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
US Oncology, Tyler Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Investigational Site 012
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
US Oncology, Virginia Oncology Assoc
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
US Oncology Spokane, Cancer Care Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20564083
Citation
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.25119.
Results Reference
result
Learn more about this trial
Safety and Efficacy Trial of Imexon Plus DTIC in Advanced Malignant Melanoma
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