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| Sponsors and Collaborators: |
Norris Comprehensive Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005841 |
Purpose
RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to kill tumor cells. Vaccine therapy plus filgrastim combined with a specific protein may be a more effective treatment for melanoma.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage III or stage IV melanoma that has been completely removed during surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Intraocular Melanoma Melanoma (Skin) |
Drug: MART-1 antigen Drug: gp100 antigen Drug: incomplete Freund's adjuvant Drug: progenipoietin Drug: tyrosinase peptide |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Trial of a Vaccine Combining Tyrosinase/GP100/Mart-1 Peptides Emulsified With Montanide ISA 51 With ProGP for Patients With Resected Stages III and IV Melanoma |
| Study Start Date: | June 2000 |
OBJECTIVES: I. Determine the maximum tolerated dose of filgrastim (G-CSF)-fetal liver tyrosine kinase-3 (Flt3K) fusion protein when combined with melanoma peptide vaccine comprising tyrosinase:368-376 peptide, gp100:209-217 antigen, and MART-1:26-35 antigen emulsified in Montanide ISA-51 in patients with completely resected stage III or IV melanoma. II. Determine the toxicity and safety of this regimen in these patients. III. Determine the immune responses to tyrosinase, MART-1, and gp100 antigens in patients before, during, and after receiving these vaccinations.
OUTLINE: This is a dose escalation, multicenter study of filgrastim (G-CSF)-fetal liver tyrosine kinase-3 (Flt3K) (G-CSF-Flt3K) fusion protein. Patients receive melanoma peptide vaccine comprising tyrosinase:368-376 peptide, gp100:209-217 antigen, and MART-1:26-35 antigen emulsified in Montanide ISA-51 subcutaneously (SQ) monthly for 6 months, and then at 9 and 12 months for a total of 8 vaccinations. Patients receive G-CSF-Flt3K fusion protein SQ daily for 3 days before, immediately after, and then daily for 6 days after each vaccination. Cohorts of 6-10 patients receive escalating doses of G-CSF-Flt3K fusion protein until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6-10 patients experience dose limiting toxicity. Patients are followed every 3 months through year 2 after resection, every 6 months for 3 years, and then annually thereafter until disease progression.
PROJECTED ACCRUAL: A total of 30-50 patients will be accrued for this study within 12-18 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven completely resected stage III or IV cutaneous, mucosal, or ocular melanoma Disease free, but at high risk of relapse Must meet 1 of the following criteria: Failed interferon alfa (IFN-A) therapy Ineligible for IFN-A therapy Refused IFN-A therapy HLA-A2.1 positive Availability of tumor tissue for analysis of gp100 antigen staining with antibody HMB-45, and for expression of tyrosinase and MART-1 antigens by immunohistochemistry Tumor cells must be positive for at least 1 antigen
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Hemoglobin at least 9.0 g/dL Platelet count at least 100,000/mm3 No coagulation or bleeding disorders Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT and SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No concurrent major medical illness of the cardiovascular system Pulmonary: No concurrent major medical illness of the respiratory system Immunologic: Hepatitis B surface antigen negative and hepatitis C antibody negative HIV negative No history of uveitis or other autoimmune inflammatory eye disease No other active autoimmune disease No known allergic reaction to Montanide ISA-51 Other: No concurrent major systemic infection including pneumonia or sepsis No concurrent major medical illness of the gastrointestinal system Not pregnant or nursing Negative pregnancy test No other malignancy within the past 5 years except curatively treated squamous cell skin cancer or carcinoma in situ of the cervix allowed 30 days after treatment
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior tyrosinase:368-376 peptide, gp100:209-217 antigen, or MART-1:26-35 antigen Chemotherapy: Not specified Endocrine therapy: No concurrent steroids Radiotherapy: At least 1 month since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics Other: At least 1 month since other prior therapy, including adjuvant therapy, for melanoma No other concurrent anticancer therapy
Contacts and Locations| United States, California | |
| City of Hope National Medical Center | |
| Los Angeles, California, United States, 91010 | |
| USC/Norris Comprehensive Cancer Center | |
| Los Angeles, California, United States, 90033-0800 | |
| Study Chair: | Jeffrey S. Weber, MD, PhD | Norris Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000067857, LAC-USC-10M993, LAC-USC-IRB-99B028, NCI-470 |
| Study First Received: | June 2, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005841 |
| Health Authority: | United States: Federal Government |
|
iris melanoma ciliary body and choroid melanoma, small size ciliary body and choroid melanoma, medium/large size extraocular extension melanoma |
recurrent intraocular melanoma stage III melanoma stage IV melanoma recurrent melanoma |
|
Eye Neoplasms Eye Diseases Recurrence Melanoma Neuroendocrine Tumors Melanoma of the choroid Neuroectodermal Tumors |
Uveal melanoma Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Intraocular melanoma Neuroepithelioma Freund's Adjuvant Nevus |
|
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Immunologic Factors Physiological Effects of Drugs |
Neoplasms, Nerve Tissue Adjuvants, Immunologic Nevi and Melanomas Pharmacologic Actions |
