Status:
COMPLETED
Cellular Adoptive Immunotherapy in Treating a Patient Who Has Undergone a Donor Stem Cell Transplant for Breast Cancer That Has Spread to the Lung
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Metastatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
RATIONALE: Biological therapy, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop tumor cells from growing. PURPOSE: This phase I trial is studying ho...
Detailed Description
OBJECTIVES: Primary * Determine the antitumor response in a patient with persistent metastatic breast cancer after prior allogeneic hematopoietic stem cell transplantation (SCT) treated with tumor-d...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of stage IIB HER2/neu-expressing breast cancer 6½ years ago
- Received a T-cell-depleted allogeneic stem cell transplantation (SCT) from a 6/6 HLA-matched sibling donor for refractory metastatic breast cancer
- Developed pulmonary metastases during adjuvant chemotherapy following modified radical mastectomy
- Pulmonary metastases progressed after prior allogeneic SCT
- Responded in an objective and measurable manner to prior allogeneic lymphocyte infusion, post-transplantation chemotherapy, and trastuzumab (Herceptin®)
- Disease limited to the thoracic cavity
- Operable tumor with at least 1 cm of surgically accessible lesion
- Preoperative risk assessment indicating ≤ 5% risk of mortality and \< 15% risk of significant morbidity for pulmonary metastasectomy
- Enrolled on protocol CC# 00-C-0119
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- ECOG performance status 0-2
- Life expectancy \> 6 months
- Negative pregnancy test
- Adequate pulmonary reserve
- Prior graft-versus-host disease (GVHD) ≤ grade 1
- No concurrent GVHD
- No active infection nonresponsive to antimicrobial therapy
- No active psychiatric disorder that would preclude study compliance
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 4 weeks since prior systemic immunosuppressive therapy
- At least 2 weeks since prior cytotoxic therapy and immunotherapy (e.g. trastuzumab \[Herceptin®\])
- No concurrent immunosuppressive therapy
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00301730
Start Date
October 1 2005
Last Update
April 28 2015
Active Locations (1)
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1
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182