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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-99-C-0138 | |||
| NCI-NMOB-9902 | |||
| NCI-T99-0075 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aldesleukin | Biological | |||
| p53 peptide vaccine | Biological | |||
| in vitro-treated peripheral blood stem cell transplantation | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Cellular immunity as measured by Elipsot assay and 51 Cr-release assay at baseline, and every 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity as measured by CTC v2.0 at baseline, and every 3 weeks | ||
| Tumor response as measured by CT scan at baseline, and every 3 months |
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DISEASE CHARACTERISTICS:
Histologically proven adenocarcinoma of the breast or ovary
Stage IV, recurrent, or progressive disease with no chemotherapy or radiotherapy options available that would increase survival
Tumor tissue available for determination of p53 protein expression and genetic mutation
HLA-A2.1 positive
No prior CNS metastases
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 underlying immune deficiency
No prior autoimmune disease including, but not limited to, the following:
No active infection requiring antibiotics
HIV negative
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Samir N. Khleif, MD | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NCI - Center for Cancer Research | Bethesda | Maryland | 20889 | United States | ||
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support |
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| Bethesda |
| Maryland |
| 20892-1182 |
| United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C082598 | aldesleukin |
| C000609547 | p53 synthetic long peptide vaccine |
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