At a glance
ClinicalIndex Comparison Record- ✓Inflammatory (stage IIIB) or responsive stage IV breast cancer with metastasis to soft tissue and/or bone; responsive defined as PR (≥50% reduction in tumor burden) or CR after initial chemotherapy or locally recurrent disease rendered disease-free by surgery/radiation without prior chemotherapy; bone disease responsive if sclerosis of prior lesions with no new lesions
- ✓Received 4-7 cycles of Adriamycin and/or taxane-based regimen for stage IIIB or IV disease; locally recurrent patients rendered NED by RT or surgery do not need prior chemotherapy
- ✓Received Cytoxan 4 gm/m² and Taxol 250 mg/m² per protocol 506.03; must be given after all other chemotherapy and before transplant
- ✓Adequate peripheral blood stem cells collected (≥2.5 × 10⁶ CD34+ cells/kg) via mobilization with Cytoxan/Taxol or FHCRC-approved cytokine protocol; syngeneic collection via G-CSF per protocol 753
- ✕Karnofsky Performance Score <70
- ✕Left ventricular ejection fraction (LVEF) <50% (must be performed in patients with CHF symptoms, abnormal cardiac exam, or Adriamycin >400 mg/m²)
- ✕Pregnant or seronegative for HIV
- ✕History of seizures or hypersensitivity to E. coli preparations
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Trial for Patients With Inflammatory (Stage IIIB) and Responsive Metastatic Stage IV Breast Cancer Using Busulfan, Melphalan and Thiotepa Followed by Autologous or Syngeneic PBSC Rescue and 12 Weeks of Post-Engraftment Immunotherapy With Low-Dose IL-2 and GM-CSF
In Brief
A Phase 2 clinical trial evaluating tamoxifen citrate, busulfan, and 6 other interventions for Estrogen Receptor-negative Breast Cancer and 7 related conditions. Completed, enrolled 50 participants across 1 site.
Detailed Summary
This phase II trial studies how well giving combination chemotherapy and peripheral blood stem cell transplant followed by aldesleukin and sargramostim works in treating patients with inflammatory stage IIIB or metastatic stage IV breast cancer. Drugs used in chemotherapy, such as busulfan, melphalan, and thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to be given so that more tumor cells are killed. Aldesleukin may stimulate the white blood cells to kill breast cancer cells. Giving aldesleukin together with sargramostim may kill more tumor cells
Study Details
Timeline
Interventions
Given orally
Given orally
Given IV
Given IV
Given SC
Given SC
Undergo autologous peripheral blood stem cell infusion
May undergo radiotherapy after completion of IL-2/GM-CSF