Clinical trial · Interventional
High Dose Chemotherapy With Amifostine and Autologous Stem Cell Transplantation for High Risk Relapsed Pediatric Solid Tumors and Brain Tumors
NCT05167370CI-TRIAL-00056119terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated as recommended by the DSMB due to inability to meet enrollment goals within the time frame allotted (target of 25 patients over 5 years).
Summary
Brief summary (as posted)
This is a study of amifostine to determine how effective it is in the reduction of infection in a high dose chemotherapy regimen with autologous stem cell rescue in children with high risk, relapsed or refractory pediatric solid tumors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumors | Brain Neoplasm | ALIAS | 0.90 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amifostine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Amifostine
- interventionNames
- Drug: Amifostine
Primary outcomes (1)
- measure
- Incidence of Bacteriemia in a High Dose Busulfan, Melphalan and Thiotepa Chemotherapy Regimen With Autologous Peripheral Blood Stem Cell Rescue in Patients With High Risk and Relapsed or Refractory Pediatric Solid Tumors
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * High risk Ewing's Sarcoma Family Tumors (ESFT) including Ewing's Sarcoma, Askin's tumor, peripheral PNET * High risk desmoplastic small round cell tumors (DSRCT) * Relapsed Wilm's tumor, diffuse anaplastic Wilm's tumor * High risk brain tumors including PNET/Medulloblastomas/germinomas * Relapsed germ cell tumors * Metastatic or relapsed rhabdoid tumors * Other relapsed/refractory pediatric embryonal tumors * Less than 30 years of age * Performance \>= 50% * Cancer Diagnosis verification and staging * Disease Response and Recovery * Adequate Organ Function (Renal, Liver, Cardiac) Exclusion Criteria: * Uncontrolled Infection * Pregnancy or Breastfeeding (For Females) * Disease Progression * Uncontrolled Intercurrent Illness * HIV Positive * Receiving other Investigational Agents * Amifostine Allergy
References
Publications (0)
Data not yet available
No reference posted for this study.