Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Intraocular Melanoma Melanoma (Skin) |
Biological: incomplete Freund's adjuvant Biological: multi-epitope melanoma peptide vaccine Biological: sargramostim |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Vaccination With Synthetic Melanoma Peptides Administered With GM-CSF-in-Adjuvant in Patients With Advanced Melanoma |
| Study Start Date: | August 2002 |
OBJECTIVES:
- Determine the antitumor immune response in patients with unresectable stage III or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, sargramostim (GM-CSF), and Montanide ISA-51.
OUTLINE: Patients receive vaccine comprising multiple synthetic melanoma peptides, sargramostim (GM-CSF), and Montanide ISA-51 on days 1, 8, 15, 29, 36, and 43. Patients undergo removal of the lymph node draining the vaccination site on day 22 to assess immune response.
PROJECTED ACCRUAL: A maximum of 29 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of melanoma
- Unresectable stage III or IV disease
- Mucosal or ocular disease allowed
- Positive HLA-A1, -A2, or -A3 expression
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
- Weight ≥ 100 pounds
- Not pregnant or nursing
- No other malignancy within the past 5 years except squamous cell or basal cell skin cancer without known metastasis, carcinoma in situ of the breast, or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior vaccination with any of the peptides used in this protocol
- More than 1 year since prior melanoma vaccine therapy
- More than 4 weeks since prior immunotherapy
- More than 4 weeks since prior growth factors
- More than 4 weeks since prior allergy shots
Chemotherapy
- More than 4 weeks since prior chemotherapy
Endocrine therapy
- More than 4 weeks since prior steroid therapy
Radiotherapy
- More than 4 weeks since prior radiotherapy
Surgery
- Prior tumor resection allowed
Contacts and Locations| United States, Virginia | |
| Cancer Center at the University of Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
| Study Chair: | Craig L. Slingluff, MD | University of Virginia |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00089206 History of Changes |
| Other Study ID Numbers: | CDR0000378170, UVACC-MEL-42, UVACC-24802, UVACC-HIC-10049 |
| 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 recurrent intraocular melanoma |
iris melanoma extraocular extension melanoma ciliary body and choroid melanoma, medium/large size |
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 Adjuvants, Immunologic Freund's Adjuvant Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013