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Phase I Study of Peptide 946 Melanoma Vaccine (Peptide 946), Peptide 946 Combined with Tetanus Peptide Melanoma Vaccine, or Peptide 946-Tetanus Peptide Conjugate in Patients with High Risk Melanoma (Summary Last Modified 05/2000)
Alternate Title Vaccine Therapy in Treating Patients With Metastatic Melanoma
Objectives I. Compare the safety and immunogenicity of peptide 946 melanoma vaccine (peptide 946), peptide 946 combined with tetanus peptide melanoma vaccine, or peptide 946-tetanus peptide conjugate in patients with high risk melanoma. Entry Criteria Disease Characteristics: Histologically confirmed unresectable metastatic melanoma (AJCC stage III or IV) OR resected melanoma with high risk of recurrence or mortality (stage IIB and above) No multiple visceral metastases greater than 3 cm in diameter Solitary brain metastases allowed if less than 2 cm in diameter and successfully treated with surgical excision or gamma knife radiation therapy HLA-A2 positive Prior/Concurrent Therapy: Biologic therapy: At least 3 months since prior interferons At least 3 months since prior growth factors No prior melanoma vaccinations No concurrent interferons No concurrent growth factors Chemotherapy: At least 3 months since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 3 months since prior agents with putative immunomodulating activity (except nonsteroidal antiinflammatory drugs) At least 3 months since prior corticosteroids No concurrent agents with putative immunomodulating activity (except nonsteroidal antiinflammatory drugs) No concurrent corticosteroids Radiotherapy: Prior radiotherapy allowed See Disease Characteristics No concurrent radiotherapy Surgery: Prior surgery allowed See Disease Characteristics Other: At least 3 months since prior allergy desensitization injections At least 3 months since other prior investigational drugs or therapy At least 14 days since acute treatment for serious infection No concurrent allergy desensitization injections No concurrent investigational drugs or therapy Patient Characteristics: Age: 18 to 79 Performance status: ECOG 0-2 Life expectancy: Greater than 12 months Hematopoietic: Absolute neutrophil count greater than 1,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL Hepatic: AST and ALT no greater than 2.5 times upper limit of normal (ULN) Bilirubin no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: No known or suspected allergies to any component of the treatment vaccine Not pregnant Negative pregnancy test Fertile patients must use effective contraception Expected Enrollment 36A maximum of 36 patients will be accrued for this study. Outline This is a randomized, open-label study. Patients are randomized to 1 of 6 treatment arms: Arm I: Patients receive peptide 946 melanoma vaccine (peptide 946) emulsified with QS21 subcutaneously (SQ). Arm II: Patients receive peptide 946 emulsified with Montanide ISA-51 (ISA-51) SQ. Arm III: Patients receive peptide 946 combined with tetanus peptide melanoma vaccine (tetanus peptide) emulsified with QS21 SQ. Arm IV: Patients receive peptide 946 combined with tetanus peptide emulsified with ISA-51 SQ. Arm V: Patients receive peptide 946-tetanus peptide conjugate emulsified with QS21 SQ. Arm VI: Patients receive peptide 946-tetanus peptide conjugate emulsified with ISA-51 SQ. Initially, 4 patients are randomized to Arm I and 4 patients are randomized to Arm II. If no dose limiting toxicities are observed in these patients, then additional patients are randomized to arms III-VI. Patients in each arm receive vaccine on day 0 and at months 1, 2, 3, 6, 9, and 12. Patients are followed at 6 and 12 months. Trial Lead Organizations University of Virginia Cancer Center
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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