Vaccine Therapy in Treating Patients With Melanoma
Recruitment status was Active, not recruiting
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.
Biological: HPV 16 E7:12-20 peptide vaccine
Biological: gp100 antigen
Biological: incomplete Freund's adjuvant
Procedure: adjuvant therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study To Access The Immunologic Response To Booster Vaccination With A Modified gp100 Melanoma Peptide (209-2M) Vaccine In Previously Vaccinated HLA-A2.1+ Patients With Melanoma|
|Study Start Date:||October 2002|
- 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.
|United States, Oregon|
|Earle A. Chiles Research Institute at Providence Portland Medical Center|
|Portland, Oregon, United States, 97213-2967|
|Study Chair:||Walter J. Urba, MD, PhD||Providence Cancer Center, Earle A. Chiles Research Institute|