Vaccine Therapy and Sargramostim in Treating Patients With Stage IV Malignant Melanoma
NCT ID: NCT00006243
Last Updated: 2013-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2000-10-31
Brief Summary
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Detailed Description
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I. Determine the immunological effects of immunization protocols utilizing MART-1:27-35 (MART-1:27-35 peptide vaccine), tyrosinase (tyrosinase peptide) or gp-100 (gp100 antigen) peptides suspended in incomplete Freund's adjuvant (IFA) in the presence of two different concentrations of sargramostim (GM-CSF).
II. Define the safety and toxicity profile of an immunization protocol utilizing varying concentrations of MART-1:27-35, tyrosinase and gp-100 peptides suspended in IFA in the presence of two different concentrations of GM-CSF.
III. Collect preliminary data on therapeutic efficacy as it relates to parameters of immune function in patients with stage IV malignant melanoma.
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
ARM I: Patients receive tyrosinase peptide, MART-1:27-35 peptide vaccine, and gp100 antigen admixed in incomplete Freund's adjuvant subcutaneously (SC) on day 1 of weeks 0, 3, 6, 9, 12, and 24.
ARM II: Patients receive tyrosinase peptide, MART-1:27-35 peptide vaccine, and gp100 antigen admixed in incomplete Freund's adjuvant SC and lower-dose sargramostim SC on day 1 of weeks 0, 3, 6, 9, 12, and 24.
ARM III: Patients receive tyrosinase peptide, MART-1:27-35 peptide vaccine, and gp100 antigen admixed in incomplete Freund's adjuvant SC and higher-dose sargramostim SC on day 1 of weeks 0, 3, 6, 9, 12, and 24.
In all arms, treatment may repeat every 3 months for up to 18 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 3 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I (vaccine therapy)
Patients receive tyrosinase peptide, MART-1:27-35 peptide vaccine, and gp100 antigen admixed in incomplete Freund's adjuvant SC on day 1 of weeks 0, 3, 6, 9, 12, and 24.
tyrosinase peptide
Given SC
MART-1:27-35 peptide vaccine
Given SC
gp100 antigen
Given SC
incomplete Freund's adjuvant
Given SC
laboratory biomarker analysis
Correlative studies
Arm II (vaccine therapy and lower-dose sargramostim)
Patients receive tyrosinase peptide, MART-1:27-35 peptide vaccine, and gp100 antigen admixed in incomplete Freund's adjuvant SC and lower-dose sargramostim SC on day 1 of weeks 0, 3, 6, 9, 12, and 24.
tyrosinase peptide
Given SC
MART-1:27-35 peptide vaccine
Given SC
gp100 antigen
Given SC
incomplete Freund's adjuvant
Given SC
sargramostim
Given SC
laboratory biomarker analysis
Correlative studies
Arm III (vaccine therapy and higher-dose sargramostim)
Patients receive tyrosinase peptide, MART-1:27-35 peptide vaccine, and gp100 antigen admixed in incomplete Freund's adjuvant SC and higher-dose sargramostim SC on day 1 of weeks 0, 3, 6, 9, 12, and 24.
tyrosinase peptide
Given SC
MART-1:27-35 peptide vaccine
Given SC
gp100 antigen
Given SC
incomplete Freund's adjuvant
Given SC
sargramostim
Given SC
laboratory biomarker analysis
Correlative studies
Interventions
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tyrosinase peptide
Given SC
MART-1:27-35 peptide vaccine
Given SC
gp100 antigen
Given SC
incomplete Freund's adjuvant
Given SC
sargramostim
Given SC
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologic proof of stage IV malignant melanoma with measurable disease
* Absolute neutrophil count (ANC) \>= 1500
* Platelets (PLT) \>= 100,000
* Alkaline phosphatase (Alk phos) =\< 3 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) =\< 3 x ULN
* Creatinine (Creat) =\< 1.5 x ULN
* Hemoglobin (Hgb) \> 9.0
* Ability to provide informed consent
* Willingness to return to a Mayo Clinic institution for follow-up
* Life expectancy \>= 12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
Exclusion Criteria
* Prior immunization with differentiation antigen peptides
* Known standard therapy for the patient's disease that is potentially curative or proven capable of extending life expectancy
* Any of the following prior therapies:
* Chemotherapy =\< 4 weeks
* Mitomycin C/nitrosoureas =\< 6 weeks
* Immunotherapy =\<4 weeks
* Biologic therapy =\< 4 weeks
* Radiation therapy =\< 4 weeks
* Radiation to \> 25% of bone marrow
* Failure to fully recover from effects of prior chemotherapy regardless of interval since last treatment
* New York Heart Association classification III or IV
* Seizure disorder
* Any of the following:
* Pregnant women
* Nursing women
* Women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], surgical sterilization, subcutaneous implants, or abstinence, etc.)
* Other concurrent chemotherapy, immunotherapy, or radiotherapy
* Active psychiatric disorder requiring medications (anti-psychotics)
* Known central nervous system metastases or carcinomatous meningitis
* History of other malignancy in last 5 years with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only (it is impossible to predict the effect of study treatment on other, potentially dormant malignant diseases)
* Known immune deficiency (patients with known immune deficiencies will likely not be able to mount an immune response to the study vaccine)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Svetomir Markovic
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Other Identifiers
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MC9973
Identifier Type: -
Identifier Source: secondary_id
CDR0000068171
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2012-02359
Identifier Type: -
Identifier Source: org_study_id
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