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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
Not Enrolling
Both
Malignant Melanoma

Thank you

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 OncologyAlbany, New York  12208
US Oncology, Tyler Cancer CenterTyler, Texas  75702
US Oncology Orlando, Cancer Centers of FLOcoee, Florida  34761
US Oncology KetteringKettering, Ohio  45409
US Oncology, Virginia Oncology AssocNorfolk, Virginia  23502
Investigational Site 009Los Angeles, California  90033
Investigational Site 002Santa Monica, California  90404
University of CO Anschutz Cancer PavilionAurora, Colorado  80010
US Oncology Greenville, Cancer Centers of the CarolinasGreenville, South Carolina  29615
Investigational Site 012Salt Lake City, Utah  84112
US Oncology Spokane, Cancer Care NorthwestSpokane, Washington  99218