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Status:

UNKNOWN

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

Lead Sponsor:

Dana-Farber Cancer Institute

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Melanoma (Skin)

Eligibility:

All Genders

Phase:

PHASE2

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 antige...

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 ...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    40 Patients enrolled

    Trial Details

    Trial ID

    NCT00085397

    Start Date

    March 1 2004

    Last Update

    February 9 2009

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    Massachusetts General Hospital

    Boston, Massachusetts, United States, 02114

    2

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

    Boston, Massachusetts, United States, 02115

    3

    Beth Israel Deaconess Medical Center

    Boston, Massachusetts, United States, 02215