Overview
Cellular Adoptive Immunotherapy in Treating a Patient Who Has Undergone a Donor Stem Cell Transplant for Breast Cancer That Has Spread to the Lung
Status:
Completed
Completed
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
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 how well cellular adoptive immunotherapy works in treating a patient who has undergone a donor stem cell transplant for breast cancer that has spread to the lung.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
National Cancer Institute (NCI)Treatments:
Aldesleukin
Paclitaxel
Trastuzumab
Criteria
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