Clinical trial · Interventional
Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer
Ex Vivo Expanded Megakaryocytes for Supportive Care of Breast Cancer Patients: A Phase I/II Study
NCT00006225CI-TRIAL-00007103completedPhase 1 / Phase 2ClinicalTrials.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: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. PURPOSE: Randomized phase I/II trial to study the effectiveness of peripheral stem cell transplantation in treating patients who have breast cancer or hematologic cancer.
Conditions
Conditions (5)
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 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic/Myeloproliferative Diseases | Myelodysplastic/Myeloproliferative Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| filgrastim | Biological | Filgrastim | ALIAS |
| in vitro-treated peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| recombinant flt3 ligand | Biological | — | UNRESOLVED |
| recombinant human thrombopoietin | Biological | — | UNRESOLVED |
| recombinant interleukin-3 | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of carcinoma of the breast or hematologic malignancies * No metastases to bone marrow * Planned high-dose chemotherapy with autologous peripheral blood stem cell transplantation * At least 2.0 million CD34+ cells/kg collected * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 to 60 Sex: * Female or male Menopausal status: * Not specified Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * SGOT or SGPT less than 2.5 times upper limit of normal (ULN) * Bilirubin less than 2.5 times ULN (except in Gilbert's syndrome) * Alkaline phosphatase less than 2.5 times ULN * No active hepatitis B or C Renal: * Creatinine clearance greater than 50 mL/min Cardiovascular: * Normal ejection fraction Pulmonary: * DLCO at least 50% predicted * FEV\_1 and/or FVC at least 75% predicted Other: * No concurrent serious nonneoplastic disease that would preclude study entry * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * See Disease Characteristics Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified
References
Publications (0)
Data not yet available
No reference posted for this study.