Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma

NCT ID: NCT00085397

Last Updated: 2009-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31

Brief Summary

RATIONALE: Vaccines made from a patient's dendritic cells may make the body build an immune response to kill tumor cells. It is not yet known whether combining vaccine therapy with either gp100 antigen or the patient's tumor cells will cause a stronger immune response and kill more tumor cells.

PURPOSE: This randomized phase II trial is studying vaccine therapy and gp100 antigen to see how well they work compared to vaccine therapy and patient's tumor cells in treating patients with stage III or stage IV melanoma.

Detailed Description

OBJECTIVES:

Primary

• Compare the tumor-specific immune response, in terms of the number of gp100-specific cytotoxic T-lymphocytes, T-cell production of interferon gamma, or T-cell proliferation in response to in vitro exposure to gp100 and tumor lysate, in patients with stage III or IV melanoma treated with autologous dendritic cells (DC) pulsed with gp100 antigen vs autologous DC fused with autologous tumor cells.

Secondary

• Compare the safety and toxicity of these regimens in these patients.
• Compare the therapeutic effect of these regimens in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

All patients undergo leukapheresis. Peripheral blood mononuclear cells are cultured to generate dendritic cells (DC).

• Arm I: Patients undergo surgical harvesting of tumor cells for subsequent fusion. Patients receive vaccination comprising DC fused with autologous tumor cells subcutaneously on day 1. Treatment repeats every 21 days for 3 courses. Patients who achieve a partial (PR) or complete response (CR) may receive an additional 3 courses.
• Arm II: Patients receive vaccination comprising DC pulsed with gp100 antigen IV on day 1. Treatment repeats every 21 days for 6 courses. Patients who achieve a PR or CR may receive an additional 6 courses.

In both arms, patients are followed monthly for 6 months.

PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this study.

Conditions

Melanoma (Skin)

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Study Groups

Arm I

Patients undergo surgical harvesting of tumor cells for subsequent fusion. Patients receive vaccination comprising dendritic cells (DC) fused with autologous tumor cells subcutaneously on day 1. Treatment repeats every 21 days for 3 courses. Patients who achieve a partial (PR) or complete response (CR) may receive an additional 3 courses.

Group Type: EXPERIMENTAL

autologous dendritic cell-tumor fusion vaccine

Intervention Type: BIOLOGICAL

Given subcutaneously

Arm II

Patients receive vaccination comprising DC pulsed with gp100 antigen IV on day 1. Treatment repeats every 21 days for 6 courses. Patients who achieve a PR or CR may receive an additional 6 courses.

Group Type: EXPERIMENTAL

gp100 antigen

Intervention Type: BIOLOGICAL

Given IV

therapeutic autologous dendritic cells

Intervention Type: BIOLOGICAL

Given IV

Interventions

autologous dendritic cell-tumor fusion vaccine

Given subcutaneously

Intervention Type: BIOLOGICAL

gp100 antigen

Given IV

Intervention Type: BIOLOGICAL

therapeutic autologous dendritic cells

Given IV

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed cutaneous melanoma

• Stage III or IV disease
• Recurrent or de novo stage III disease allowed if disease is unresectable and no definitive treatment is available
• gp100- and HLA-A201-positive
• Surgically accessible tumor, defined by 1 of the following:

• Pulmonary lesions approachable by thoracoscopic procedure
• Skin or superficial soft tissue or lymph node lesions amenable to resection under local anesthesia
• Malignant ascites or pleural effusion
• Measurable disease in addition to surgically accessible tumor > 2.0 cm
• No CNS metastases
• No mucosal or ocular melanoma

PATIENT CHARACTERISTICS:

Age

• Any age

Performance status

• ECOG 0-1

Life expectancy

• More than 3 months

Hematopoietic

• WBC > 3,000/mm^3
• Platelet count > 75,000/mm^3

Hepatic

• Bilirubin < 2.0 mg/dL

Renal

• Creatinine < 2.0 mg/dL

Immunologic

• No active infection requiring treatment
• No clinically significant autoimmune disorder
• No immune deficiency disorder
• HIV negative

Other

• Antecubital vein accessible for leukapheresis
• No other malignancy within the past 5 years except nonmelanoma skin cancer or squamous cell carcinoma in situ of the cervix
• No pre-existing comorbid disease that would preclude study compliance
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior melanoma vaccine therapy
• More than 6 weeks since prior immunotherapy

Chemotherapy

• No prior chemotherapy for metastatic melanoma

Endocrine therapy

• No concurrent corticosteroids

Radiotherapy

• More than 6 weeks since prior radiotherapy

Surgery

• Not specified

Other

• No concurrent systemic immunosuppressive therapy

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Principal Investigators

Frank Haluska, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

David Avigan, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Clinical Trials Office - Massachusetts General Hospital

Role: primary

877-726-5130

F. Stephen Hodi, MD

Role: primary

617-632-5053

Clinical Trials Office - Beth Israel Deaconess Medical Center

Role: primary

617-667-9925

Other Identifiers

DFCI-03123

Identifier Type: -

Identifier Source: secondary_id

CDR0000369699

Identifier Type: -

Identifier Source: org_study_id