Clinical trial · Interventional
Allogeneic Stem Cell Transplant After ATG, High-Dose Melphalan, and Fludarabine for Patients With Breast Cancer
Pilot Study Of Allogeneic Peripheral Blood Progenitor Cell Transplantation In Patients With Chemotherapy-Refractory Or Poor-Prognosis Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated early due to poor enrollment
Summary
Brief summary (as posted)
RATIONALE: Giving chemotherapy, such as fludarabine and melphalan, before a donor peripheral blood stem cell transplant helps stop the growth of tumor cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining tumor cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin, cyclosporine, and methotrexate before or after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well antithymocyte globulin, high-dose melphalan, fludarabine, and allogeneic peripheral stem cell transplant work in treating patients with metastatic adenocarcinoma of the breast.
Conditions
Conditions (1)
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 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-thymocyte globulin | Biological | — | UNRESOLVED |
| cyclosporine | Drug | — | UNRESOLVED |
| filgrastim | Biological | Filgrastim | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| graft-versus-tumor induction therapy | Biological | — | UNRESOLVED |
| melphalan | Drug | Melphalan | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment
- interventionNames
- Biological: anti-thymocyte globulin
- Biological: filgrastim
- Biological: graft-versus-tumor induction therapy
- Biological: therapeutic allogeneic lymphocytes
- Drug: cyclosporine
- Drug: fludarabine phosphate
- Drug: melphalan
- Drug: methotrexate
- Procedure: peripheral blood stem cell transplantation
Primary outcomes (3)
- measure
- Number of Participants With Adverse Events
- timeFrame
- 5 years post transplant
- measure
- Number of Participants With Long-term Engraftment of Allogeneic Stem Cells and Lymphocytes
- timeFrame
- 30 days post transplant
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the breast
* Metastatic disease
* Meets 1 of the following criteria:
* Chemotherapy-unresponsive disease defined as 1 of the following:
* Less than a partial response to 2 consecutive chemotherapy regimens that included an anthracycline and a taxane in combination or succession
* Progression of disease during or within 3 months of completion of a taxane, anthracycline, or platinol-based regimen
* Histologically confirmed tumor involvement on bone marrow biopsy
* Measurable or evaluable disease\* defined as the following:
* Bidimensionally reproducible measurable mass by physical examination, ultrasonography, radiography, CT scan, or MRI
* Evaluable lesions apparent on clinical exam, x-ray, CT scan, or MRI which do not fit the criteria for measurability (e.g., ill-defined post-surgical masses or masses assessable in 1 dimension only)
* Elevation of biological markers (e.g., CA 27.29) is considered evaluable disease NOTE: \*Bone lesions or pleural or peritoneal effusion alone are not considered measurable or evaluable disease
* Appropriate candidate for allogeneic stem cell transplantation
* No active CNS metastases
* Available HLA-identical sibling donor
* 6/6 antigen match
* Donor CD34 cells at least 2 times 10\^6/kg recipient weight
* Hormone receptor status:
* Estrogen receptor negative or positive
* Estrogen receptor positive tumors must demonstrate progression on at least 1 hormonal manipulation
PATIENT CHARACTERISTICS:
Age
* 18 to 60
Sex
* Female
Menopausal status
* Not specified
Performance status
* Karnofsky 70-100% OR
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* WBC at least 1,500/mm\^3
* Platelet count at least 30,000/mm\^3
Hepatic
* Bilirubin less than 3 times normal\*
* AST and ALT less than 3 times normal\* NOTE: \*Unless abnormality due to malignancy
Renal
* Creatinine no greater than 1.6 mg/dL
Cardiovascular
* LVEF greater than 40% by echocardiography or MUGA
* No myocardial infarction within the past 6 months
Pulmonary
* DLCO greater than 40% of predicted
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No serious localized or systemic infection
* No hypersensitivity to E. coli-derived products
* No history of non-breast malignant disease within the past 5 years except completely excised nonmelanoma skin cancer or carcinoma in situ of the cervix
* No chronic inflammatory disorder requiring concurrent glucocorticosteroids or other immunosuppressive medication
* No psychological condition or social situation that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* No concurrent glucocorticoids
Radiotherapy
* No prior radiotherapy to an indicator lesion unless the lesion shows evidence of progression after discontinuation of the therapy
Surgery
* Not specified
Other
* No concurrent immunosuppressive medicationReferences
Publications (0)
Data not yet available