Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 15 to 75 UARIZ-1718H NCI-V84-0058

Objectives

I.  Evaluate whether treatment with therapy selected on the basis of in-vitro 
sensitivity results (DTIC, actinomycin-D, vinblastine, BCNU, 
4'-deoxydoxorubicin, vindesine, recombinant leukocyte A interferon) yields 
different response rates and survival when compared to standard treatment with 
DTIC for metastatic melanoma.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients between 15 and 75 years of 
age with a pathologic diagnosis of melanoma who have objectively measurable 
disease.  Prior treatment with DTIC is not allowed.  Patients must have a life 
expectancy of at least three months, an ECOG performance status of 3 or less, 
adequate pretreatment WBC and platelet counts, and adequate renal (serum 
creatinine less than 2.0 mg/ml) and hepatic function (serum bilirubin less 
than 2.0 mg/dl).  If their tumor was not cultured at the time of diagnostic 
biopsy, patients must undergo tumor biopsy for clonogenic assay.

Expected Enrollment

224 patients (52 patients per year) will be accrued; 5 years will be required 
to complete the study (4 years for accrual and a minimal period of 1 year for 
followup).

Outline

Partially randomized study.  Patients whose tumor grows in culture are 
randomized to Arms I and II.  Patients whose tumor fails to grow in culture 
are assigned to Arm I.
Arm I:  Single-agent Chemotherapy.  Dacarbazine, DTIC, NSC-45388.
Arm II:  Single-agent Therapy.  Treatment with the most active agent in 
clonogenic assay:  DTIC; Actinomycin-D, ACT-D, NSC-3053; BCNU, NSC-409962; 
Vinblastine, VBL, NSC-49842; 4'-Deoxydoxorubicin, DxDx, NSC-267469; Vindesine, 
DAVA, NSC-245467; or Recombinant Leukocyte A Interferon, rIFN-alpha-A, 
IFN-alpha.

Trial Contact Information

Trial Lead Organizations

Arizona Cancer Center at University of Arizona Health Sciences Center

Frank Meyskens, MD, FACP, Protocol chair		Ph: 714-456-6310 Email: flmeyske@uci.edu