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Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006385
First received: October 4, 2000
Last updated: November 5, 2011
Last verified: December 2002

October 4, 2000
November 5, 2011
September 2000
October 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00006385 on ClinicalTrials.gov Archive Site
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Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma
Phase II Evaluation of Immunization With an HLA-A2 Multi-Epitope Peptide Vaccine Containing MART-1 (NSC #672643), gp100 (NSC #683472), and Tyrosinase (NSC #699048) Peptides Alone or in Combination With GM-CSF, IFN Alpha-2b, or GM-CSF + IFN Alpha-2b in Patients With Metastatic Melanoma

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Biological therapies such as sargramostim and interferon alfa use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known if vaccine therapy if more effective with or without biological therapy for melanoma.

PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy with or without biological therapy in treating patients who have metastatic melanoma.

OBJECTIVES:

  • Determine immune response of vaccination with melanoma associated antigens (MART-1:27-35, gp100:209-217 (210M), and tyrosinase:368-376 (370D)) on the number of peptide specific CD8+ T-cell precursors in HLA-A2 positive patients with metastatic melanoma.
  • Determine the influence of sargramostim (GM-CSF) and/or interferon alfa-2b (IFN-A) on the immune responses of these patients and toxicity of this melanoma peptide vaccine.
  • Determine any antitumor and anti-pigmentary response that may result from immunization against MART-1, gp100 and tyrosinase peptides, and determine the relationship between such clinical observations and immune responses against lineage antigens with or without GM-CSF and/or IFN-A.
  • Compare the relapse free survival and overall survival of patients treated with melanoma peptide vaccine alone or in combination with GM-CSF and/or IFN-A.

OUTLINE: This is a randomized, multicenter study.

Patients are randomized to 1 of 4 treatment arms.

  • Arm I: Patients receive multiepitope peptide (MEP) vaccine comprising MART-1:27-35, gp100:209-217 (210M), and tyrosinase:368-376 (370D) peptides. Each peptide is separately emulsified in Montanide ISA-51 and administered subcutaneously (SC) (for a total of 2 injections per peptide) on days 1 and 15.
  • Arm II: Patients receive MEP vaccine as in arm I and sargramostim (GM-CSF) subcutaneously (SC) daily on days 1-14.
  • Arm III: Patients receive MEP vaccine as in arm I and interferon alfa-2b SC three times a week.
  • Arm IV: Patients receive MEP vaccine as in arm I, GM-CSF as in arm II, and interferon alfa-2b as in arm III.

Treatment continues every 4 weeks for a maximum of 13 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 92 patients (23 per arm) will be accrued for this study within 13-16 months.

Interventional
Phase 2
Allocation: Randomized
Primary Purpose: Treatment
Melanoma (Skin)
  • Biological: MART-1 antigen
  • Biological: gp100 antigen
  • Biological: incomplete Freund's adjuvant
  • Biological: recombinant interferon alfa
  • Biological: sargramostim
  • Biological: tyrosinase peptide
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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October 2006   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically proven stage IV melanoma
  • Measurable disease

    • At least 1 lesion must be a minimum of 1.0 cm in diameter
    • Bone metastases are not considered to be measurable disease
    • No prior radiotherapy to area of measurable disease unless there is clearly progressive disease in this site or measurable disease exists outside the area of prior radiotherapy
  • HLA-A2 positive
  • No brain disease by MRI or CT scan within 4 weeks prior to randomization

    • Prior brain disease allowed if no evidence of active disease by 2 successive MRI evaluations completed at least 3 months apart

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Lymphocyte count greater than 700/mm ^3

Hepatic:

  • SGOT no greater than 2 times upper limit of normal (ULN)
  • Bilirubin no greater than 2 times ULN
  • Alkaline phosphatase and lactic dehydrogenase no greater than 2 times ULN

Renal:

  • Creatinine no greater than 1.8 mg/dL

Other:

  • No significant detectable infection
  • HIV negative
  • No other malignancy within the past 5 years except:

    • Any carcinoma in situ
    • Lobular carcinoma in situ of the breast
    • Carcinoma in situ of the cervix
    • Atypical melanocytic hyperplasia
    • Melanoma in situ
    • Basal cell or squamous cell skin cancer
  • No autoimmune disorders or conditions of immunosuppression
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior MART-1:27-35, gp100:209-217 (210M), or tyrosinase:368-376 (370D) peptide
  • Greater than 4 weeks since prior adjuvant immunotherapy, including sargramostim (GM-CSF) or interferon alfa-2b

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy:

  • At least 2 weeks since prior and no concurrent systemic corticosteroids, including oral steroids (i.e., prednisone, dexamethasone); continuous use of topical steroid creams or ointments; or any inhalers containing steroids

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy for local control or palliation and recovered

Surgery:

  • Recovered from any prior major surgery
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006385
CDR0000068263, E-1696
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Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: John M. Kirkwood, MD University of Pittsburgh
National Cancer Institute (NCI)
December 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP