Clinical trial · Interventional
High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors
High-Dose Thiotepa With Autologous Stem Cell Rescue in Patients With Malignancies Refractory to Conventional Chemotherapy
- 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: 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. PURPOSE: Phase II trial to study the effectiveness of high-dose thiotepa plus peripheral stem cell transplantation in treating patients with refractory solid tumors.
Conditions
Conditions (8)
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 |
| Extragonadal Germ Cell Tumor | Extragonadal Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Retinoblastoma | Retinoblastoma | ONTOLOGY_EXACT | 0.98 |
| Testicular Germ Cell Tumor | Testicular Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous bone marrow transplantation | Procedure | — | UNRESOLVED |
| filgrastim | Biological | Filgrastim | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| thiotepa | Drug | Thiotepa | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Malignant solid tumors * Must have failed conventional treatment or for whom conventional therapy is not available * Measurable disease by MRI or CT scan * Intraocular retinoblastomas may be measured by direct visualization * Germ cell tumors may be measured by tumor markers * No known bone marrow involvement PATIENT CHARACTERISTICS: Age: * Any age Performance status: * Lansky 60-100% for patients 16 and under * Karnofsky 60-100% for patients over 16 Life expectancy: * At least 8 weeks Hematopoietic: * Absolute neutrophil count at least 1,000/mm\^3 * Platelet count at least 75,000/mm\^3 * If parameters not met, must have adequate stem cell yield Hepatic: * Bilirubin no greater than 1.5 times the upper limit of normal (ULN) * SGOT and SGPT no greater than 2.5 times the ULN (unless liver involvement by tumor) Renal: * Creatinine within normal limits OR * Creatinine clearance at least 70 mL/min Cardiovascular: * Fractional shortening greater than 28% on echocardiogram OR * Ejection fraction at least 55% on RNCA prior to first cycle of thiotepa Pulmonary: * DLCO greater than 55% of predicted (only required if there is clinical evidence of pulmonary dysfunction) Other: * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior bone marrow or peripheral blood stem cell rescue allowed Chemotherapy: * At least 4 weeks since prior chemotherapy if absolute neutrophil count is less than 1,000/mm\^3 or platelet count is less than 75,000/mm\^3, and recovered (i.e. adequate stem cells collected to predict hematopoietic recovery) * No concurrent chemotherapy except for dexamethasone for antiedema effects Endocrine therapy: * No concurrent use of corticosteroids used solely as antiemetics Radiotherapy: * At least 4 weeks since radiotherapy if absolute neutrophil count is less than 1,000/mm\^3 or platelet count is less than 75,000/mm\^3, and recovered (i.e. adequate stem cells collected to predict hematopoietic recovery) * No concurrent radiotherapy Surgery: * Not specified
References
Publications (0)
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