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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00019916 |
Purpose
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 |
|---|---|---|
|
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: | Allocation: Randomized Primary Purpose: Treatment |
| 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.
Eligibility| 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:
Contacts and Locations| 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) |
More Information
| ClinicalTrials.gov Identifier: | NCT00019916 History of Changes |
| Obsolete Identifiers: | NCT00001828 |
| Other 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 |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer recurrent breast cancer recurrent ovarian epithelial cancer stage IV ovarian epithelial cancer |
|
Breast Neoplasms Ovarian Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female |
Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Aldesleukin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |