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Sponsors and Collaborators: |
NCI - Center for Cancer Research-Medical Oncology National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00019903 |
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: This phase I/II trial is studying the side effects of p53 vaccine therapy and to see how well it works in treating patients with adenocarcinoma of the ovary with either no evidence of disease or elevated biomarkers.
Condition | Intervention | Phase |
Ovarian Cancer |
Drug: aldesleukin Drug: incomplete Freund's adjuvant Drug: p53 peptide vaccine Drug: sargramostim Drug: therapeutic autologous dendritic cells Procedure: in vitro-treated peripheral blood stem cell transplantation |
Phase I Phase II |
MedlinePlus related topics: | Cancer Ovarian Cancer |
Drug Information available for: | Aldesleukin Sargramostim Granulocyte-macrophage colony-stimulating factor Freund's adjuvant Montanide ISA 51 |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Vaccine Therapy With Tumor Specific p53 Peptides in Adult Patients With Low BurdenAdenocarcinoma of the Ovary |
Estimated Enrollment: | 45 |
Study Start Date: | June 2000 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: All patients undergo apheresis prior to therapy, prior to every other course, and 1 month after the last course.
Patients are assigned to one of two treatment arms.
Patients are followed at 1 month. Patients who are off therapy are followed every 2-4 months for 2 years.
PROJECTED ACCRUAL: A total of 45 patients (9-16 per treatment arm) will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven adenocarcinoma of the ovary
Tumor tissue available for determination of p53 protein expression and genetic mutation
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Immunologic:
No prior autoimmune disease including, but not limited to, the following:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Maryland | |||||
NCI - Center for Cancer Research | |||||
Bethesda, Maryland, United States, 20892 | |||||
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |||||
Bethesda, Maryland, United States, 20892-1182 |
NCI - Center for Cancer Research-Medical Oncology |
National Cancer Institute (NCI) |
Principal Investigator: | Samir N. Khleif, MD | NCI - Center for Cancer Research-Medical Oncology |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000067278, NCI-99-C-0137, NCI-NMOB-9903, NCI-T99-0074 |
First Received: | July 11, 2001 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00019903 |
Health Authority: | United States: Federal Government |
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