Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma

NCT ID: NCT00104845

Last Updated: 2013-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2011-09-30

Brief Summary

RATIONALE: Vaccines made from DNA may make the body build an effective immune response to kill tumor cells.

PURPOSE: This randomized phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage IIB, stage IIC, stage III, or stage IV melanoma.

Detailed Description

OBJECTIVES:

Primary

• Determine the safety and feasibility of vaccination with human and mouse gp100 DNA in patients with stage IIB, IIC, III, or IV melanoma.
• Determine the maximum tolerated dose of this regimen in these patients.
• Compare the antibody and T-cell response in patients treated with two different vaccination schedules.

Secondary

• Assess antitumor response in patients treated with this regimen.

OUTLINE: This is a randomized, crossover, dose-escalation study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive human gp100 DNA vaccine intramuscularly (IM) once in weeks 1, 4, and 7. Patients then receive mouse gp100 DNA vaccine IM once in weeks 10, 13, and 16.
• Arm II: Patients receive mouse gp100 DNA vaccine IM once in weeks 1, 4, and 7. Patients then receive human gp100 DNA vaccine IM once in weeks 10, 13, and 16.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 6-9 patients (at least 3 per treatment arm) receive escalating doses of human and mouse gp100 DNA vaccines until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 9 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed at 3 weeks and then annually for 15 years.

PROJECTED ACCRUAL: Approximately 18-27 patients will be accrued for this study within 6-9 months.

Conditions

Melanoma (Skin)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

human gp100 DNA vaccine

Patients receive human gp100 DNA vaccine intramuscularly (IM) once in weeks 1, 4, and 7. Patients then receive mouse gp100 DNA vaccine IM once in weeks 10, 13, and 16.

Group Type: EXPERIMENTAL

human gp100 plasmid DNA vaccine

Intervention Type: BIOLOGICAL

mouse gp100 plasmid DNA vaccine

Intervention Type: BIOLOGICAL

mouse gp100 DNA vaccine

Patients receive mouse gp100 DNA vaccine IM once in weeks 1, 4, and 7. Patients then receive human gp100 DNA vaccine IM once in weeks 10, 13, and 16

Group Type: EXPERIMENTAL

human gp100 plasmid DNA vaccine

Intervention Type: BIOLOGICAL

mouse gp100 plasmid DNA vaccine

Intervention Type: BIOLOGICAL

Interventions

human gp100 plasmid DNA vaccine

Intervention Type: BIOLOGICAL

mouse gp100 plasmid DNA vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Patients free of disease after surgical resection* must have refused high-dose interferon alfa OR experienced recurrent disease during prior treatment with interferon alfa NOTE: *Patients who underwent surgical resection must have had the surgery within the past year
• HLA-A0201 positive
• No detectable brain metastases

PATIENT CHARACTERISTICS:

Age

• Any age

Performance status

• Karnofsky 80-100%

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 3,000/mm^3
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 10 g/dL
• No active bleeding

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Albumin ≥ 3.5 g/dL
• AST and ALT ≤ 2.5 times ULN
• Lactate dehydrogenase ≤ 2 times ULN
• No clinical history of hepatitis B or C

Renal

• Creatinine ≤ 2.0 mg/dL

Immunologic

• No clinical history of HIV
• No clinical history of HTLV-1
• No active infection requiring antibiotics within the past 72 hours
• No history of collagen vascular, rheumatologic, or other autoimmune disorder
• No grade 1 fever within the past 72 hours

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Weight ≥ 25 kg
• No serious underlying medical condition that would preclude study participation
• No preexisting uveal or choroidal eye disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics
• More than 4 weeks since prior immunotherapy
• No prior immunization with any class of vaccine containing gp100, including whole cell, shed antigen, or cell lysate vaccines

Chemotherapy

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

Endocrine therapy

• No concurrent corticosteroids that would preclude study participation

Radiotherapy

• More than 4 weeks since prior radiotherapy
• No concurrent radiotherapy

Surgery

• See Disease Characteristics

Other

• Recovered from all prior therapy
• No other concurrent medication that would preclude study participation
• No other concurrent investigational agents
• No other concurrent systemic therapy

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jedd D. Wolchok, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

P30CA008748

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MSKCC-IRB-03007

Identifier Type: -

Identifier Source: secondary_id

03-007

Identifier Type: -

Identifier Source: org_study_id