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
Phase 1/Phase 2
N/A
N/A
N/A
N/A
Not Enrolling
Both
Malignant Melanoma
Both
Malignant Melanoma
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine the maximally tolerated dose of imexon plus DTIC
Safety Issue:
Yes
Principal Investigator
Evan Hersh, MD
Investigator Role:
Study Director
Investigator Affiliation:
AmpliMed Corporation
Authority:
United States: Food and Drug Administration
Study ID:
AMP-005
NCT ID:
NCT00327600
Start Date:
July 2005
Completion Date:
December 2007
Related Keywords:
- Malignant Melanoma
- Melanoma
Name | Location |
|---|---|
| US Oncology Albany, New York Oncology | Albany, New York 12208 |
| US Oncology, Tyler Cancer Center | Tyler, Texas 75702 |
| US Oncology Orlando, Cancer Centers of FL | Ocoee, Florida 34761 |
| US Oncology Kettering | Kettering, Ohio 45409 |
| US Oncology, Virginia Oncology Assoc | Norfolk, Virginia 23502 |
| Investigational Site 009 | Los Angeles, California 90033 |
| Investigational Site 002 | Santa Monica, California 90404 |
| University of CO Anschutz Cancer Pavilion | Aurora, Colorado 80010 |
| US Oncology Greenville, Cancer Centers of the Carolinas | Greenville, South Carolina 29615 |
| Investigational Site 012 | Salt Lake City, Utah 84112 |
| US Oncology Spokane, Cancer Care Northwest | Spokane, Washington 99218 |
