Clinical trial · Interventional
Cellular Adoptive Immunotherapy in Treating a Patient Who Has Undergone a Donor Stem Cell Transplant for Breast Cancer That Has Spread to the Lung
Adoptive Immunotherapy With Costimulated Tumor-Derived T Cells After Allogeneic Hematopoietic Stem Cell Transplantation
NCT00301730CI-TRIAL-00017658completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| therapeutic tumor infiltrating lymphocytes | Biological | Therapeutic Tumor Infiltrating Lymphocytes | ALIAS |
| trastuzumab | Biological | Trastuzumab | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.