Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma - Full Text View

Sponsor:	Dana-Farber Cancer Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00085397

Purpose

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.

Condition	Intervention	Phase
Melanoma (Skin)	Biological: autologous dendritic cell-tumor fusion vaccine Biological: gp100 antigen Biological: therapeutic autologous dendritic cells	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Randomized Phase II Study of Immunization Against Melanoma Comparing Autologous Dendritic Cells Pulsed With gp100 Peptide to Autologous Dendritic Cells Fused With Autologous Tumor Cells

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Immune response [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	March 2004

Arms	Assigned Interventions
Arm I: Experimental 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.	Biological: autologous dendritic cell-tumor fusion vaccine Given subcutaneously
Arm II: Experimental 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.	Biological: gp100 antigen Given IV Biological: therapeutic autologous dendritic cells Given IV

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085397

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Clinical Trials Office - Beth Israel Deaconess Medical Center 617-667-9925
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Contact: F. Stephen Hodi, MD 617-632-5053
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130

Sponsors and Collaborators

Dana-Farber Cancer Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Frank Haluska, MD, PhD	Massachusetts General Hospital
Principal Investigator:	David Avigan, MD	Beth Israel Deaconess Medical Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000369699, DFCI-03123
Study First Received:	June 10, 2004
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00085397 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent melanoma
stage III melanoma
stage IV melanoma

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on November 30, 2009