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| Sponsors and Collaborators: |
University of Virginia National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003224 |
Purpose
RATIONALE: Vaccines made from peptide 946 may make the body build an immune response to kill tumor cells. Combining these vaccines with proteins from the tetanus vaccine, and/or with either QS21 or Montanide ISA-51 may be an effective treatment for metastatic melanoma.
PURPOSE: Randomized phase I trial to study the effectiveness of vaccines made from peptide 946 with or without tetanus peptide, QS21, or Montanide ISA-51 in treating patients with metastatic melanoma that cannot be surgically removed or with melanoma that is likely to recur.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Drug: QS21 Drug: incomplete Freund's adjuvant Drug: peptide 946 melanoma vaccine Drug: peptide 946-tetanus peptide conjugate melanoma vaccine Drug: tetanus peptide melanoma vaccine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Protocol for the Evaluation of the Safety and Immunogenicity of Vaccination With a Synthetic Melanoma Peptide in Patients With High Risk Melanoma |
| Estimated Enrollment: | 36 |
| Study Start Date: | February 1996 |
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.
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.
PROJECTED ACCRUAL: A maximum of 36 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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
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
Contacts and Locations| United States, Virginia | |
| Cancer Center, University of Virginia HSC | |
| Charlottesville, Virginia, United States, 22908 | |
| Study Chair: | Craig L. Slingluff, MD | University of Virginia |
More Information
| Study ID Numbers: | CDR0000066086, UVACC-HIC-6346, UVA-HIC-6346, NCI-H98-0010 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003224 |
| Health Authority: | United States: Federal Government |
|
stage II melanoma stage III melanoma stage IV melanoma recurrent melanoma |
|
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma Freund's Adjuvant |
Nevus QS 21 Recurrence Neuroendocrine Tumors Melanoma |
|
Neoplasms Neoplasms by Histologic Type Immunologic Factors Physiological Effects of Drugs |
Neoplasms, Nerve Tissue Adjuvants, Immunologic Nevi and Melanomas Pharmacologic Actions |
