Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients
Completed · Phase 1
Conditions studied: Breast Cancer, Ovarian Cancer
In brief
This is a single-center, randomized, single-blinded, three-arm phase Ib study of the folate binding protein vaccines E39 and J65. The study target population are patients with breast or ovarian cancer diagnosis who have been treated and are without evidence of disease. Disease-free subjects after standard of care multi-modality therapy will be screened and HLA typed. E39 and J65 are cytotoxic T-lymphocyte-eliciting peptide vaccines that are restricted to HLA-A2+ patients (approximately 50% of the U.S. population).
Key facts
- Study ID
- NCT02019524
- Run by
- COL George Peoples, MD, FACS
- People needed
- 39
- Starts
- 2013-09-30
- Expected to finish
- 2016-12-06
- Last updated by the study team
- 2020-03-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have breast or ovarian cancer
- Patients must have completed primary breast or ovarian cancer therapy (i.e., surgery, chemotherapy, immunotherapy and/or radiation therapy as appropriate per standard of care for patient's specific cancer)
- Patients must be without evidence of residual disease as assessed by their treatment team
- Patients must be either post-menopausal or surgically post-menopausal
- Patients must be HLA-A2 positive
- Patients must have a good performance status (ECOG<2)
You may not qualify if…
- HLA-A2 negative patients
- Currently receiving immunosuppressive therapy to include chemotherapy, steroids, or methotrexate
- In poor health (Karnofsky <60%, ECOG >2)
- Total bilirubin >1.5, creatinine >2, hemoglobin <10, platelets <50,000, WBC <2,000
- Active pulmonary disease requiring medication to include multiple inhalers
- Of child-bearing age with intact reproductive organs
- Involved in other experimental protocols (except with permission of the other study PI)
- History of autoimmune disease
Where it is running
- University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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