Clinical trial · Interventional
Busulfan, Melphalan, and Antithymocyte Globulin Followed By Umbilical Cord Blood Transplant in Treating Young Patients With Refractory or Relapsed Malignant Solid Tumors
A Phase I Study to Examine the Toxicity of Killer IG-Like Receptor (KIR) Mismatched Umbilical Cord Blood for Pediatric Patients With Malignant Solid Tumors
- 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: Giving chemotherapy before a donor umbilical cord blood stem cell transplant helps stop the growth of tumor cells. It also helps stop the patient's immune system from rejecting the donor's stem cells when they do not exactly match the patient's blood. The donated stem cells may replace the patient's immune cells and help destroy any remaining tumor cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and methylprednisolone after the transplant may stop this from happening. PURPOSE: This phase I trial is studying the side effects of busulfan, melphalan, and antithymocyte globulin followed by umbilical cord blood transplant in treating young patients with refractory or relapsed malignant solid tumors.
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 |
|---|---|---|---|
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| anti-thymocyte globulin | Biological | — | UNRESOLVED |
| busulfan | Drug | Busulfan | ALIAS |
| cyclosporine | Drug | — | UNRESOLVED |
| flow cytometry | Other | — | UNRESOLVED |
| graft-versus-tumor induction therapy | Biological | — | UNRESOLVED |
| immunologic technique | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Safety
- measure
- Incidence of graft-versus-host disease
Secondary outcomes (2)
- measure
- Donor/host chimerism status
- measure
- Immune function post-transplant
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of malignant solid tumor
* Relapsed or refractory disease
* No isolated local recurrence of disease (in the site of the primary tumor) \> 1 year after completing therapy
* No brain tumors or brain metastases
* Unrelated cord blood donor available
* May be HLA 6/6 matched (HLA-A, -B, -DR) OR mismatched for 1, 2, or 3 of these HLA loci, but must be mismatched for HLA-C group as indicated by their following killer cell immunoglobulin-like receptor (KIR) group specificity:
* KIR2DL1
* Cw 2
* Cw 0307
* Cw 4, 5, 6
* Cw 0707, 0709
* Cw 1204, 1205
* All other Cw 15 alleles
* Cw 1602
* Cw 17
* Cw 18
* KIR2DL2
* Cw 1
* All other Cw 3 alleles
* All other Cw 7 alleles
* Cw 8
* Cw 1202, 1203, 1206
* Cw 1301
* Cw 1402, 1403
* Cw 1507
* Cw 1601, 1604
* Cord blood specimen must have ≥ 1 x 10\^7 nucleated cells/kg patient ideal body weight
PATIENT CHARACTERISTICS:
* ECOG performance status (PS) 0-2 OR Lansky PS 70-100%
* Cardiac ejection fraction ≥ 50%
* Creatinine clearance ≥ 50%
* Bilirubin ≤ 3.0 mg/dL
* DLCO ≥ 70% OR O\_2 saturation ≥ 95% on room air
PRIOR CONCURRENT THERAPY:
* Prior autologous stem cell transplantation allowedReferences
Publications (0)
Data not yet available