Clinical trial · Interventional
Vaccine Therapy Plus Interleukin-2 in Treating Women With Stage IV, Recurrent, or Progressive Breast or Ovarian Cancer
Vaccine Therapy With Tumor Specific p53 Peptides in Adult Patients With Adenocarcinoma of the Breast or Ovary
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| in vitro-treated peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| p53 peptide vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Cellular immunity as measured by Elipsot assay and 51 Cr-release assay at baseline, and every 3 weeks
Secondary outcomes (2)
- measure
- Toxicity as measured by CTC v2.0 at baseline, and every 3 weeks
- measure
- Tumor response as measured by CT scan at baseline, and every 3 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 * p53-positive tumor by immunohistochemical analysis * HLA-A2.1 positive * No prior CNS metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * ECOG 0 or 1 Life expectancy: * More than 3 months Hematopoietic: * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 2.0 mg/dL * SGOT or SGPT no greater than 4 times normal * Hepatitis B surface antigen negative * Hepatitis C antibody negative Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No New York Heart Association class III or IV heart disease * No myocardial infarction within past 6 months * No prior congestive heart failure * No prior ventricular arrhythmias or other arrhythmias requiring therapy Immunologic: * Must have positive intradermal delayed hypersensitivity test for 1 of the following: * Mumps * Trichophyton * Tetanus * Candida * PPD * No underlying immune deficiency * No prior autoimmune disease including, but not limited to, the following: * Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia * Systemic lupus erythematosus, Sjögren's syndrome, or scleroderma * Myasthenia gravis * Goodpasture's syndrome * Addison's disease * Hashimoto's thyroiditis * Active Graves' disease * No active infection requiring antibiotics * HIV negative Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other active malignancy within the past 2 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy and recovered * At least 1 year since prior bone marrow transplantation Chemotherapy: * At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: * Prior anticancer hormonal therapy allowed * At least 4 weeks since prior systemic steroids and recovered Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered Surgery: * Not specified Other: * Chronic suppressive antibiotics allowed
References
Publications (0)
Data not yet available