Clinical trial · Interventional
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors
A Phase I Study of Thiotepa in Combination With Carboplatin and Topotecan With Peripheral Blood Progenitor Cell Support for the Treatment of Children With Recurrent or Refractory Solid 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): Study enrollment did not meet expected goals
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 I trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have recurrent or refractory 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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| thiotepa | Drug | Thiotepa | ALIAS |
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 30 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven recurrent or refractory pediatric solid tumor * Bone marrow metastases allowed PATIENT CHARACTERISTICS: Age: * 1 to 30 Performance status: * 0-2 Life expectancy: * At least 2 months Hematopoietic: * Absolute neutrophil count at least 1,000/mm3 * Platelet count at least 100,000/mm3 (transfusion independent) * Hemoglobin at least 10 g/dL (RBC transfusion allowed) Hepatic: * Bilirubin no greater than 1.5 times normal * SGOT no greater than 2.5 times normal Renal: * Adequate renal function as defined by one of the following: * GFR by creatinine clearance * Radioisotope GFR * Iothalamate at least 70 mL/min Cardiovascular: * Adequate cardiac function as defined by one of the following: * Ejection fraction at least 55% by MUGA * Fractional shortening at least 28% by echocardiogram Neurologic: * Adequate CNS function as defined by: * Seizure disorder, if present, controlled by anticonvulsants * CNS toxicity no greater than grade 2 Other: * No uncontrolled infections * Not pregnant or nursing * No allergy to platinum compounds * No history of allergy to etoposide (unless mobilization phase not required) PRIOR CONCURRENT THERAPY: Biologic therapy: * Recovered from prior immunotherapy * At least 1 week since prior cytokines * At least 3 months since prior bone marrow or peripheral blood stem cell transplantation * No concurrent immunomodulator * No concurrent cytokines Chemotherapy: * At least 3 weeks (6 for nitrosourea) since prior chemotherapy and recovered * No prior thiotepa * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * Recovered from prior radiotherapy * At least 6 months since prior total body irradiation conditioning * No concurrent radiotherapy to greater than 10% of total liver, lung, or bone marrow Surgery: * Not specified
References
Publications (0)
Data not yet available