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Portland, Oregon 97213


RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer. PURPOSE: Phase I trial to study the effectiveness of booster vaccinations in preventing cancer recurrence in patients who have melanoma.

Study summary:

OBJECTIVES: - Determine the toxicity of booster vaccination with gp100:209-217 (210M) peptide and HPV-16 E7 (12-20) peptide vaccine emulsified in Montanide ISA-51 administered at least 12 months after prior vaccination in patients with melanoma. - Determine T-cell response to modified gp100: 209-217 (210M) peptide and unmodified native gp100 peptide in these patients. - Determine T-cell response to the control HLA-A2-restricted CD8 epitope of HPV-16 E7 (12-20) peptide vaccine in these patients. OUTLINE: Patients undergo leukapheresis on day 0. Patients receive vaccination comprising gp100:209-217 (210M) and HPV-16 E7 (12-20) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on day 1 and between days 25-30 in the absence of disease progression or unacceptable toxicity. Patients undergo a second leukapheresis 2-4 weeks after the second vaccination. Patients who remain disease free for 6 months after the second vaccination may receive additional booster vaccinations SC every 6 months for 3 years. Patients are followed at 3 and 6 months after the second vaccination and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1.5 years.


DISEASE CHARACTERISTICS: - Completed treatment on PPMC-IRB-99-9* - At least 12 months since last vaccination NOTE: *Patients are not required to have received every planned vaccine as long as the reason for stopping was not disease progression or dose-limiting toxicity - No current evidence of melanoma, as defined by one of the following: - Disease-free since completion of PPMC-IRB-99-9 - Recurrence occurred but was completely resected 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 mg/dL Renal - Creatinine no greater than 2 mg/dL Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 6 months after study participation - No other concurrent medical or psychiatric illness that would preclude study participation - No concurrent significant systemic infection - No other concurrent cancer or at low risk for recurrence of prior cancers PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics Chemotherapy - Not specified Endocrine therapy - No concurrent systemic corticosteroids for intercurrent illness Radiotherapy - Not specified Surgery - Recovered from prior major surgery



Primary Contact:

Study Chair
Walter J. Urba, MD, PhD
Providence Cancer Center, Earle A. Chiles Research Institute

Backup Contact:


Location Contact:

Portland, Oregon 97213
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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