Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Vaccine Therapy in Treating Patients Who Have Stage II, Stage III, or Stage IV Melanoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed 18 and over Pharmaceutical / Industry GENZ-ADVMEL-001-99 DFCI-00069, GENZ-2000-P-000380/1, NCT00010309

Objectives

I. Determine the safety and the maximum tolerated dose of vaccines containing 
two adenoviral vectors encoding the melanoma antigens Melan-A/MART-1 and gp100 
in patients with stage II-IV melanoma.

II. Assess the dose-response changes in the frequency of MART-1 and gp100 
reactive T cells (CD4+ and CD8+) in patients receiving one of three different 
vaccine regimens.

III. Assess the T-cell response to one melanoma antigen following three 
treatments with the other antigen in these patients.

IV. Assess the effect of concomitant vaccination with both antigens on T-cell 
response in these patients.

Entry Criteria

Disease Characteristics:

Histologically confirmed stage II, III, or IV cutaneous malignant melanoma

No evidence of disease at time of entry to protocol

Definitive complete surgical resection within past 12 months

HLA-A2 positive

Prior/Concurrent Therapy:

Biologic therapy:
 No prior or concurrent immunotherapy
 At least 3 months since prior interferon therapy

Chemotherapy:
 No prior or concurrent chemotherapy

Endocrine therapy:
 No prior or concurrent immunosuppressants

Radiotherapy:
 At least 4 weeks since prior radiotherapy

Surgery:
 At least 4 weeks since prior surgery

Other:
 No other prior or concurrent experimental anticancer therapy

Patient Characteristics:

Age:
 18 or over

Performance status:
 ECOG 0-1

Life expectancy:
 Not specified

Hematopoietic:
 WBC at least 3,000 cells/mm3
 Platelet count at least 100,000 cells/mm3
 No clinically significant hematologic disease that would preclude study

Hepatic:
 SGOT and SGPT less than 2 times upper limit of normal
 Bilirubin less than 2 mg/dL
 No clinically significant hepatic disease that would preclude study

Renal:
 Creatinine less than 2 mg/dL
 No clinically significant renal disease that would preclude study

Cardiovascular:
 No clinically significant cardiac disease that would preclude study

Other:
 No clinically significant underlying condition that would preclude study
 No significant autoimmune disease or other major immune system disorder
 HIV negative
 HTLV negative
 Hepatitis B and C negative
 No active infection requiring parenteral antibiotics
 No psychiatric disorder that could hinder protocol compliance
 Not pregnant or nursing
 Fertile patients must use effective contraception

Expected Enrollment

A total of 24-36 patients will be accrued over 1 year.

Outline

This is a dose escalation study.  Patients are sequentially enrolled on 1 of 3 
treatment arms.  Each treatment arm has 3 groups.

Arm I: Patients receive Ad2/MART-1v2 vaccine and Ad2/gp100v2 vaccine 
intradermally (ID) at the lowest dose level once every three weeks for either 
6 or 15 weeks depending on assignment.

Arm II: Patients receive Ad2/gp100v2 vaccine and Ad2/MART-1v2 vaccine ID at 
the mid-range dose level once every three weeks for either 6 or 15 weeks 
depending on assignment.

Arm III: Patients receive Ad2/MART-1v2 vaccine and Ad2/gp100v2 vaccine ID at 
the highest dose level once every three weeks for either 6 or 15 weeks 
depending on assignment.

Cohorts of 3-6 patients receive escalating doses of Ad2/MART-1v2 and/or 
Ad2/gp100v2 vaccines in each arm until the maximum tolerated dose (MTD) is 
reached.  The MTD is defined as the dose preceding that at which 2 of 6 
patients experience dose-limiting toxicity.

Patients are followed at 3 months, 6 months, and 1 year after completion of 
treatment.

Trial Contact Information

Trial Lead Organizations

Genzyme Corporation

Amy E. Bock, Protocol chair		Ph: 617-252-7608

Registry Information
Official Title		Phase I/II Trial Investigating The Safety And Immunogenicity Of Adenoviruses Encoding The Melan-A/MART-1 And gp 100 Melanoma Antigens Administered Intradermally To Patients With Stage II-IV Melanoma
Trial Start Date		2000-11-01
Registered in ClinicalTrials.gov		NCT00010309
Date Submitted to PDQ		2001-01-09
Information Last Verified		2002-07-01