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Sponsors and Collaborators: |
Providence Cancer Center, Earle A. Chiles Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00052988 |
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.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Biological: HPV 16 E7:12-20 peptide vaccine Biological: gp100 antigen Biological: incomplete Freund's adjuvant Procedure: adjuvant therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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 |
OBJECTIVES:
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.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Completed treatment on PPMC-IRB-99-9*
No current evidence of melanoma, as defined by one of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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 |
Study ID Numbers: | CDR0000258479, PPMC-IRB-02-63, NCI-5925 |
Study First Received: | January 27, 2003 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00052988 History of Changes |
Health Authority: | United States: Federal Government |
stage I melanoma stage II melanoma stage III melanoma |
Neuroectodermal Tumors Immunologic Factors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Adjuvants, Immunologic |
Neuroepithelioma Freund's Adjuvant Nevus Neuroendocrine Tumors Melanoma |
Neoplasms by Histologic Type Immunologic Factors Neoplasms, Nerve Tissue Physiological Effects of Drugs Adjuvants, Immunologic Pharmacologic Actions Melanoma |
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Neoplasms, Germ Cell and Embryonal Nevi and Melanomas Freund's Adjuvant |