- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001440
Autologous T-Cell Transplantation and the Immunotherapy of Residual Disease in Breast Cancer: Pilot Study of Vaccine-Driven T-Cell Expansion in Patients Treated With Dose-Intensive Chemotherapy
Pilot Study of Autologous T Cells and/or IL-2 for the Enhancement of Immune Reconstitution After Dose-Intensive Chemotherapy for Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Cancer Institute (NCI)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
PRE-CHEMOTHERAPY ELIGIBILITY:
Patients must have a histologically confirmed diagnosis of stage II, III, or IV infiltrating breast cancer; stage II patients must be considered high risk with greater than four positive axillary lymph nodes at primary surgery. Patients with metastatic disease must have their relapse confirmed pathologically. All pathological material must be reviewed and the diagnosis confirmed by the Department of Pathology at the NIH Clinical Center prior to acceptance on the protocol.
Patients enrolled on this protocol may receive chemotherapy by one of the following mechanisms: (1) Any dose intensive chemotherapy regimen given as part of a separate NCI breast cancer protocol. In such a case, prior approval of the principal investigator for that study should be obtained. It must be emphasized that no clinical or research endpoints of the chemotherapy protocol must be compromised by participation in this immune reconstitution protocol.
(2) In some cases, patients may receive non-experimental chemotherapy from their referring physicians. Patients may not be enrolled on this study if they are to receive chemotherapy as part of an experimental study performed outside of the NCI; patients who are receiving high-dose chemotherapy requiring stem cell support at other institutions are specifically excluded from participation in this study. The determination of whether non-experimental chemotherapy qualifies as dose intensive will be made by the principal investigator.
All stage II and III patients must represent a new diagnosis and must have received no prior chemotherapy.
Patients with metastatic disease can represent a new diagnosis as stage IV, or may have metastatic disease that represents a relapse after adjuvant therapy for any other stage of breast cancer. However, a prior of one year must have elapsed since the completion of adjuvant chemotherapy.
Patient must have a Hct of greater than or equal to 24%, a WBC count of greater than or equal to 3000 per mm(3), and platelets greater than or equal to 100,000 per mm(3) at the time of enrollment.
Patients must have no history of abnormal bleeding tendency or predisposition to infection.
Serum creatinine of less than 1.5 or Crcl of less than 60 cc per min. Higher values may be allowed if it is determined by the principal investigator that elevated values are due to tumor impairment of organ function.
AST and ALT less than 3 times the upper limits of normal. Higher values may be allowed if it is determined by the principal investigator that elevated values are due to tumor impairment of organ function.
In the presence of known pulmonary disease of symptoms, patients must have a pO2 greater than 65 and FEV1 and FVC greater than 65% of predicted (unless directly due to tumor involvement prior to therapy).
LVEF greater than or equal to 45% post-chemotherapy, as measured by MUGA or 2-D echocardiogram.
All patients must be free of a significant history or active symptomatology of coronary artery disease, congestive heart failure, neurologic disease, or chronic obstructive pulmonary disease.
Patients must have a Karnofsky performance score of greater than 70% (ECOG 0 or 1) and a life expectancy of at least three months.
Patients must be able to give informed consent.
POST-CHEMOTHERAPY ELIGIBILITY:
After completion of dose intensive chemotherapy, patients must continue to meet the eligibility criteria above. However, for patients who are to receive only autologous T cells (and no IL-2 therapy), cardiac ejection fraction will not represent a treatment eligibility criteria. In addition, patients must meet the criteria as outlined below.
To proceed with the protocol after completion of dose intensive chemotherapy, stage II and III patients must have no evidence of disease. Patients requiring adjuvant radiation therapy will receive this prior to proceeding with this protocol. Patients with metastatic disease must have demonstrated a least a partial response to chemotherapy (greater than 50% reduction in measurable disease).
To be eligible to proceed with T cell infusion and/or IL-2 administration after completion of chemotherapy, patients must have a Hb of greater than or equal to 9, an ANC greater than or equal to 1000, and a platelet count of greater than or equal to 75,000.
Patients must have recovered from any non-hematologic toxicities of dose-intensive chemotherapy and radiation therapy prior to receiving T cell infusions or IL-2.
All women will be tested for pregnancy at enrollment and prior to T cell transfer or IL-2 treatment; individuals must not be pregnant.
Patients must not be HIV positive or have Hepatitis B or C infection.
Patients must not have a chronic need to steroid or anti-coagulant therapy. However, for patients who are to receive only autologous T cells, steroid or anti-coagulant therapy will not be an exclusion criteria.
Patients must not present with any unusual medical or psychiatric risk.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Mackall CL, Fleisher TA, Brown MR, Andrich MP, Chen CC, Feuerstein IM, Horowitz ME, Magrath IT, Shad AT, Steinberg SM, et al. Age, thymopoiesis, and CD4+ T-lymphocyte regeneration after intensive chemotherapy. N Engl J Med. 1995 Jan 19;332(3):143-9. doi: 10.1056/NEJM199501193320303.
- Mackall CL, Fleisher TA, Brown MR, Magrath IT, Shad AT, Horowitz ME, Wexler LH, Adde MA, McClure LL, Gress RE. Lymphocyte depletion during treatment with intensive chemotherapy for cancer. Blood. 1994 Oct 1;84(7):2221-8.
- Henderson IC, Hayes DF, Gelman R. Dose-response in the treatment of breast cancer: a critical review. J Clin Oncol. 1988 Sep;6(9):1501-15. doi: 10.1200/JCO.1988.6.9.1501.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 950146
- 95-C-0146
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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