Clinical trial · Interventional
Amifostine to Protect From Side Effects of PSCT in Treating Patients With Solid Tumors
A Phase I Study of the Chemoprotectant Amifostine With Autologous Stem Cell Transplantation for High Risk or Relapsed Pediatric Solid Tumors and Brain Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Withdrawn due to slow accrual
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of high-dose chemotherapy. PURPOSE: Phase I trial to study the effectiveness of amifostine in protecting from the side effects of peripheral stem cell transplantation in treating patients who have high-risk or relapsed solid tumors.
Conditions
Conditions (9)
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 and Central Nervous System Tumors | — | UNRESOLVED | — |
| Childhood Germ Cell Tumor | Childhood Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Chordoma | Chordoma | ONTOLOGY_EXACT | 0.98 |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Retinoblastoma | Retinoblastoma | ONTOLOGY_EXACT |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| amifostine trihydrate | Drug | — | UNRESOLVED |
| busulfan | Drug | Busulfan | ALIAS |
| filgrastim | Drug | Filgrastim | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
| peripheral blood stem cell transplantation (PBSC) | Procedure | — | UNRESOLVED |
| thiotepa | Drug | Thiotepa | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Solid/brain tumor patients (1-18 years)
- description
- Patients with solid tumor or brain tumor in the 1-18 years old stratum.
- interventionNames
- Drug: amifostine trihydrate
- Drug: busulfan
- Drug: filgrastim
- Drug: melphalan
- Drug: thiotepa
- Procedure: peripheral blood stem cell transplantation (PBSC)
- type
- EXPERIMENTAL
- label
- Solid/brain tumor patients (19-45 years)
- description
- Patients with solid tumor or brain tumor in the 19-45 years old stratum.
- interventionNames
- Drug: amifostine trihydrate
- Drug: busulfan
- Drug: filgrastim
- Drug: melphalan
- Drug: thiotepa
- Procedure: peripheral blood stem cell transplantation (PBSC)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed high-risk or relapsed solid tumors or brain tumors, including: * Metastatic or relapsed Ewing's sarcoma * Metastatic or relapsed rhabdomyosarcoma * Refractory Wilms' tumor * Diffuse anaplastic Wilms' tumor * Stage III or IV neuroblastoma * Recurrent retinoblastoma * Metastatic or relapsed germ cell tumors * Metastatic or relapsed other soft tissue sarcomas * Small cell ovarian sarcoma * Metastatic or relapsed primitive neuroectodermal tumors of the bone * Recurrent brain tumors * Desmoplastic small round cell tumors * Recurrent or metastatic chordomas * Metastatic or relapsed hepatoblastoma * Patients receive peripheral blood stem cell transplantation only if in complete remission or in very good partial remission with no disease progression * Must have radiologic, nuclear image, or histologic verification of relapse * Age 1 to 45 * Performance status:Karnofsky 70-100% * Absolute neutrophil count greater than 1,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin count at least 10 g/dL * Bilirubin less than 2 times upper limit of normal (ULN) * SGOT or SGPT less than 2.5 times ULN * Creatinine less than 2 times ULN * Creatinine clearance greater than 70 mL/min * Cardiac shortening fraction greater than 30% * Cardiac ejection fraction greater than 45% * At least 1 week since prior hematopoietic growth factor and recovered * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered * Recovered from any prior therapy Exclusion Criteria: * Osteogenic sarcoma * Less than 4 months * Uncontrolled bleeding * Congestive heart failure * Uncontrolled hypertension * Asthma * Pregnant or nursing * Uncontrolled metabolic disease * Active severe infection * Allergy to aminothiol compounds * Prior bone marrow transplantation * Other concurrent investigational agents
References
Publications (0)
Data not yet available