Clinical trial · Interventional
Donor Stem Cell Transplant in Treating Young Patients With Relapsed or Refractory Solid Tumors
A Phase I Study to Examine the Toxicity of Allogeneic Stem Cell Transplantation for Pediatric Solid Tumors With Relapsed or Therapy Refractory Disease
- 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: A peripheral stem cell, bone marrow, or umbilical cord blood transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving busulfan and melphalan with or without antithymocyte globulin before transplant and cyclosporine with methylprednisolone or methotrexate after transplant may stop this from happening. PURPOSE: This phase I trial is studying the side effects of donor stem cell transplant in treating young patients with relapsed or refractory solid tumors.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic bone marrow transplantation | Procedure | — | UNRESOLVED |
| anti-thymocyte globulin | Biological | — | UNRESOLVED |
| busulfan | Drug | Busulfan | ALIAS |
| cyclosporine | Drug | — | UNRESOLVED |
| melphalan | Drug | Melphalan | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| methylprednisolone | Drug | — | UNRESOLVED |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of relapsed or refractory solid tumor, including, but not limited to, relapsed neuroblastoma, relapsed Ewing's sarcoma, and relapsed rhabdomyosarcoma
* No isolated local disease recurrence at the site of the primary tumor \> 1 year after completion of prior therapy
* No brain tumor or brain metastases
* Related or unrelated hematopoietic stem cell donor available, meeting 1 of the following criteria:
* Matched for HLA-A, -B, -C, -DR, and -DQ (9/10 or 10/10 allelles) (marrow or peripheral blood)
* Matched for HLA-A, -B, and -DR (5/6 or 6/6 allelles) (cord blood)
* Cord blood specimen must contain ≥ 2 x 10 \^7 nucleated cells/kg body weight
PATIENT CHARACTERISTICS:
Age
* 30 and under
Performance status
* ECOG 0-1 OR
* Lansky 80-100%
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Bilirubin ≤ 3.0 mg/dL
Renal
* Creatinine clearance ≥ 50 mL/min
Cardiovascular
* Ejection fraction ≥ 50%
Pulmonary
* DLCO ≥ 70% OR
* O\_2 saturation ≥ 95% on room air
Other
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Prior autologous stem cell transplantation allowed
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specifiedReferences
Publications (0)
Data not yet available