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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00085397
First Posted: June 11, 2004
Last Update Posted: February 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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:


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

Primary Outcome Measures:
  • Immune response

Estimated Enrollment: 40
Study Start Date: March 2004
Arms Assigned Interventions
Experimental: 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.
Biological: autologous dendritic cell-tumor fusion vaccine
Given subcutaneously
Experimental: 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.
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00085397


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

ClinicalTrials.gov Identifier: NCT00085397     History of Changes
Other Study ID Numbers: CDR0000369699
DFCI-03123
First Submitted: June 10, 2004
First Posted: June 11, 2004
Last Update Posted: February 9, 2009
Last Verified: April 2008

Keywords provided by National Cancer Institute (NCI):
recurrent melanoma
stage III melanoma
stage IV melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Vaccines
Immunologic Factors
Physiological Effects of Drugs