Vaccine Therapy in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Virginia
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00089219
First received: August 4, 2004
Last updated: February 6, 2009
Last verified: April 2006
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Purpose
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: This randomized phase I/II trial is studying three different doses of a vaccine and comparing them to see how well they work in treating patients with stage IIIB, stage IIIC, or stage IV melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Intraocular Melanoma Melanoma (Skin) |
Biological: incomplete Freund's adjuvant Biological: multi-epitope melanoma peptide vaccine Biological: sargramostim |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Vaccination With Multiple Synthetic Melanoma Peptides Recognized by Helper T-Cells in Patients With Advanced Melanoma |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Safety if less than 33% of patients experience a dose-limiting toxicity at day 22 [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Immune response by Proliferation Assay at day 22 [ Designated as safety issue: No ]
| Study Start Date: | July 2003 |
OBJECTIVES:
- Determine the immune response in patients with stage IIIB, IIIC, or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF).
OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive vaccine comprising low-dose multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF) on days 1, 8, 15, 29, 36, and 43.
- Arm II: Patients receive vaccine comprising medium-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I.
- Arm III: Patients receive vaccine comprising high-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I.
On day 22, the lymph node draining the vaccination site is removed to determine whether the immune system is responding to the vaccine.
PROJECTED ACCRUAL: A maximum of 38 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of stage IIIB, IIIC, or IV melanoma
- HLA-DR1, -DR4, -DR11, -DR13, or -DR15 positive
- Brain metastases allowed at the discretion of the principle investigator
PATIENT CHARACTERISTICS:
Age
- 18 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
- Prior diagnosis of other cancer allowed
- Not pregnant or nursing
- Weight ≥ 110 pounds
- No uncontrolled diabetes
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 4 weeks since prior growth factors
- More than 4 weeks since prior allergy shots
- 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
- No prior vaccination with any of the peptides used in this study
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
Other
- More than 1 month since prior investigational drugs or therapies
- No other concurrent investigational drugs or therapies
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00089219
Locations
| United States, Virginia | |
| University of Virginia Cancer Center | |
| Charlottesville, Virginia, United States, 22908 | |
Sponsors and Collaborators
University of Virginia
Investigators
| Study Chair: | Craig L. Slingluff, MD | University of Virginia |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00089219 History of Changes |
| Other Study ID Numbers: | CDR0000378171, UVACC-MEL-41, UVACC-28502, UVACC-HIC-10464 |
| Study First Received: | August 4, 2004 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage III melanoma stage IV melanoma recurrent melanoma ciliary body and choroid melanoma, medium/large size |
extraocular extension melanoma iris melanoma recurrent intraocular melanoma |
Additional relevant MeSH terms:
|
Melanoma Uveal Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
Eye Neoplasms Neoplasms by Site Eye Diseases Uveal Diseases Freund's Adjuvant Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013