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
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
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 1
Accepts Healthy Volunteers?
No
Details
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