Vaccine Therapy in Treating Patients With Melanoma
This study has been completed.
Sponsor:
Providence Cancer Center, Earle A. Chiles Research Institute
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003895
First received: November 1, 1999
Last updated: April 2, 2013
Last verified: December 2002
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of melanoma vaccine in treating patients who have melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Biological: HPV 16 E7:12-20 peptide vaccine Biological: gp100 antigen Biological: incomplete Freund's adjuvant Procedure: conventional surgery |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Randomized Phase II Trial to Determine the Immune Response to a Mutated gp100 Mela |
Resource links provided by NLM:
Genetics Home Reference related topics:
mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | April 1999 |
| Study Completion Date: | July 2003 |
OBJECTIVES:
- Determine the toxic effects of gp100:209-217 (210M) and human papilloma virus (HPV)-16 E7(12-20) peptide vaccine in patients with primary melanoma at least 1 mm thick.
- Determine the T-cell response to modified self-gp100:209-217 (210M) peptide and unmodified parental gp100 peptide in these patients.
- Determine the T-cell response to the control HLA-A2.1-restricted cytotoxic T-lymphocyte epitope of HPV-16 E7(12-20) in these patients.
- Determine whether analysis of antigen-specific T cells using specific HLA-A2/peptide tetramers is an effective method for monitoring the immune response in patients undergoing peptide vaccination compared to ELISPOT, LDA, and measurement of intracellular cytokine production (fastimmune).
- Compare induction of primary peptide-specific T-cell immune responses to self gp100 peptide versus foreign E7 peptide in these patients.
- Compare immune response induced by vaccinating every 2 weeks for 6 months (13 vaccinations) vs every 3 weeks for 6 months (9 vaccinations) in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gp100:209-217 (210M) and HPV-16 E7(12-20) peptides mixed with Montanide ISA-51 subcutaneously at the site of the primary melanoma and in the extremities and abdomen. Vaccinations continue every 2 weeks for 6 months (13 total injections).
- Arm II: Patients receive vaccinations as in arm I every 3 weeks for 6 months (9 total injections).
Patients undergo sentinel lymph node biopsy and possible wide local excision approximately 10 days after the second vaccination.
Patients are followed every 3 months for 6 months, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter until recurrence.
PROJECTED ACCRUAL: A total of 36 patients (18 per arm) will be accrued for this study within 14 months.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically proven primary melanoma of Breslow thickness at least 1.0 mm
- Prior wide local excision allowed if within past 3 months
- No prior lymph node dissection
- HLA-A2 positive
- No ascites or pleural effusions
- No clinically detectable distant metastases
PATIENT CHARACTERISTICS:
Age:
- Over 16
Performance status:
- Karnofsky 80-100%
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9 g/dL
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
Renal:
- Creatinine no greater than 2 mg/dL
Pulmonary:
- No chronic obstructive pulmonary disease
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No significant systemic infection
- HIV negative
- No history of major psychiatric illness that would preclude study compliance
- No concurrent illness requiring systemic corticosteroids
- No other significant medical illness that would increase risk of immunotherapy
- No other cancers or deemed at low risk of recurrence
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- No concurrent systemic corticosteroids
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
- Recovered from prior major surgery
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003895
Locations
| United States, Oregon | |
| Earle A. Chiles Research Institute at Providence Portland Medical Center | |
| Portland, Oregon, United States, 97213-2967 | |
Sponsors and Collaborators
Providence Cancer Center, Earle A. Chiles Research Institute
Investigators
| Study Chair: | John W. Smith, MD | Providence Cancer Center, Earle A. Chiles Research Institute |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00003895 History of Changes |
| Other Study ID Numbers: | CDR0000067065, PPMC-IRB-99-9, NCI-T98-0081 |
| Study First Received: | November 1, 1999 |
| Last Updated: | April 2, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I melanoma stage II melanoma stage III melanoma |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue |
Nevi and Melanomas Freund's Adjuvant Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013