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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00019916 |
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. It is not yet known whether combining vaccine therapy with interleukin-2 is effective in treating breast and ovarian cancer.
PURPOSE: This randomized phase I/II trial is studying the side effects of vaccine therapy and interleukin-2 and to see how well they work in treating women with stage IV, recurrent, or progressive breast or ovarian cancer.
Condition | Intervention | Phase |
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Breast Cancer Ovarian Cancer |
Biological: aldesleukin Biological: p53 peptide vaccine Procedure: in vitro-treated peripheral blood stem cell transplantation |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Vaccine Therapy With Tumor Specific p53 Peptides in Adult Patients With Adenocarcinoma of the Breast or Ovary |
Study Start Date: | June 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, pilot study. Patients are randomized to 1 of 2 treatment arms.
All patients undergo apheresis of autologous peripheral blood mononuclear cells, which are harvested and selected for monocytes on day -6. The monocyte fraction is cultured with sargramostim (GM-CSF) and interleukin-4 for 7 days and then pulsed with p53 peptide vaccine.
Patients are followed at 1 month and then every 2-4 months for 2 years.
PROJECTED ACCRUAL: A maximum of 34 patients 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:
Tumor tissue available for determination of p53 protein expression and genetic mutation
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Immunologic:
Must have positive intradermal delayed hypersensitivity test for 1 of the following:
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, 20889 | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 |
Principal Investigator: | Samir N. Khleif, MD | National Cancer Institute (NCI) |
Study ID Numbers: | CDR0000067279, NCI-99-C-0138, NCI-NMOB-9902, NCI-T99-0075 |
Study First Received: | July 11, 2001 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00019916 History of Changes |
Health Authority: | United States: Federal Government |
stage IV breast cancer recurrent breast cancer recurrent ovarian epithelial cancer stage IV ovarian epithelial cancer |
Anti-Infective Agents Anti-HIV Agents Ovarian Neoplasms Skin Diseases Gonadal Disorders Genital Neoplasms, Female Breast Neoplasms Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian Epithelial Cancer |
Antiviral Agents Recurrence Genital Diseases, Female Aldesleukin Anti-Retroviral Agents Interleukin-2 Ovarian Cancer Endocrinopathy Adenocarcinoma Breast Diseases Endocrine Gland Neoplasms |
Anti-Infective Agents Anti-HIV Agents Ovarian Neoplasms Skin Diseases Antineoplastic Agents Gonadal Disorders Genital Neoplasms, Female Breast Neoplasms Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases |
Antiviral Agents Pharmacologic Actions Adnexal Diseases Genital Diseases, Female Neoplasms Aldesleukin Neoplasms by Site Anti-Retroviral Agents Therapeutic Uses Breast Diseases Endocrine Gland Neoplasms |