Vaccine Therapy With or Without Sargramostim in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
Evaluation of GM-CSF-in-Adjuvant and the Number of Vaccine Sites on Immunization With Multiple Synthetic Melanoma Peptides
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 peripheral blood. Combining vaccine therapy with sargramostim may cause a stronger immune response and kill more tumor cells.
PURPOSE: This randomized phase II trial is studying vaccine therapy and sargramostim to see how well they work compared to vaccine therapy alone in treating patients with stage II B, stage IIC, stage III, or stage IV melanoma.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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 (GM-CSF).
- Compare immune response in patients treated with these vaccinations administered at 1 vs 2 sites.
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive vaccination comprising multiple synthetic melanoma peptides and Montanide ISA-51 at 1 injection site.
- Arm II: Patients receive vaccination comprising multiple synthetic melanoma peptides and Montanide ISA-51 at 2 injection sites.
- Arm III: Patients receive vaccination comprising multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF) at 1 injection site.
- Arm IV: Patients receive vaccination comprising multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF at 2 injection sites.
In all arms, treatment repeats once weekly for 6 weeks. Patients return for booster vaccinations at weeks 12, 26, 39, and 52.
PROJECTED ACCRUAL: A maximum of 124 patients will be accrued for this study.
Studietype
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
District of Columbia
-
Washington, District of Columbia, Forente stater, 20010
- Washington Cancer Institute at Washington Hospital Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forente stater, 19111-2497
- Fox Chase Cancer Center
-
Pittsburgh, Pennsylvania, Forente stater, 15232
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
-
-
Texas
-
Houston, Texas, Forente stater, 77030-4009
- MD Anderson Cancer Center at University of Texas
-
-
Virginia
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Charlottesville, Virginia, Forente stater, 22908
- Cancer Center at the University of Virginia
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Masking: Ingen (Open Label)
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 10524
- UVACC-MEL-43
- FCCC-03045
- MDA-2003-0720
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