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Vaccine Therapy in Treating Patients With Melanoma



Vaccine Therapy in Treating Patients With Melanoma

For Condition: stage 3 melanoma,stage 1 melanoma,stage 2 melanoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Earle A. Chiles Research Institute
Synopsis: 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.
Details: OBJECTIVES: I. 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. II. Determine the T-cell response to modified self-gp100:209-217 (210M) peptide and unmodified parental gp100 peptide in these patients. III. 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. IV. 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). V. Compare induction of primary peptide-specific T-cell immune responses to self gp100 peptide versus foreign E7 peptide in these patients. VI. 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. PROTOCOL OUTLINE: This is a randomized study. Patients are randomized to one of two 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:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY 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-A2.1 positive No ascites or pleural effusions No clinically detectable distant metastases --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 --Patient Characteristics-- Age: Over 16 Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: - WBC at least 3,500/mm3 - Platelet count at least 100,000/mm3 - 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JohnSmith,  Study Chair,  Earle A. Chiles Research Institute

Earle A. Chiles Research Institute at Providence Portland Medical Center
Portland,  Oregon,  97213-2967
United States
 


Additional Information:
Study ID Numbers:  CDR0000067065;  PPMC-IRB-99-9,NCI-T98-0081
Study Start Date: April 1999
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003895

Other Stage 3 Melanoma Studies:
1. Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma

2. Vaccine Therapy in Treating Patients With Melanoma

3. Vaccine Therapy in Treating Patients With Melanoma

4. Vaccine Therapy in Treating Patients With Stage II or Stage III Melanoma That Has Been Surgically Removed

5. Vaccine Therapy in Treating Patients With Primary Stage II Melanoma

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