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Status:

COMPLETED

Vaccine Therapy With or Without Sargramostim in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma

Lead Sponsor:

Craig L Slingluff, Jr

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Melanoma (Skin)

Eligibility:

All Genders

12+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peri...

Detailed Description

OBJECTIVES: * Compare immune response in patients with stage IIB-IV melanoma treated with vaccination comprising multiple synthetic melanoma peptides and Montanide ISA-51 with vs without sargramostim...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of melanoma
  • Stage IIB, IIC, III, or IV disease
  • Must express HLA-A1, -A2, or -A3
  • No ocular melanoma
  • PATIENT CHARACTERISTICS:
  • Age
  • 12 and over
  • Performance status
  • ECOG 0-1
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count \> 1,000/mm\^3
  • Platelet count \> 100,000/mm\^3
  • Hemoglobin \> 9 g/dL
  • Hepatic
  • Liver function tests ≤ 2.5 times upper limit of normal (ULN)
  • Renal
  • Creatinine ≤ 1.5 times ULN
  • Cardiovascular
  • No New York Heart Association class III or IV heart disease
  • Other
  • Not pregnant or nursing
  • No other malignancy within the past 5 years except basal cell or squamous cell skin cancer without brain metastasis, carcinoma in situ of the breast, or carcinoma in situ of the cervix
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • More than 4 weeks since prior immunotherapy
  • More than 4 weeks since prior growth factors
  • More than 4 weeks since prior allergy shots
  • No prior vaccine therapy for melanoma or any other cancer with any of the peptides used in this study
  • More than 12 weeks since prior melanoma vaccine therapy\* NOTE: \*Prior melanoma vaccine allowed only for patients with disease progression during or after administration of the vaccine
  • Chemotherapy
  • More than 4 weeks since prior chemotherapy
  • Endocrine therapy
  • More than 4 weeks since prior steroids
  • Radiotherapy
  • More than 4 weeks since prior radiotherapy
  • Surgery
  • Not specified

Exclusion

    Key Trial Info

    Start Date :

    September 1 2003

    Trial Type :

    INTERVENTIONAL

    End Date :

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00089193

    Start Date

    September 1 2003

    Last Update

    December 23 2014

    Active Locations (5)

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

    Page 1 of 2 (5 locations)

    1

    Washington Cancer Institute at Washington Hospital Center

    Washington D.C., District of Columbia, United States, 20010

    2

    Fox Chase Cancer Center

    Philadelphia, Pennsylvania, United States, 19111-2497

    3

    Hillman Cancer Center at University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, United States, 15232

    4

    MD Anderson Cancer Center at University of Texas

    Houston, Texas, United States, 77030-4009