Clinical trial · Interventional
Temozolomide Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Malignant Glioma or Recurrent CNS or Other Solid Tumors
A Phase I/II Trial of Temodar in Pediatric Patients and Young Adults With High-Risk or Recurrent 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: 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: This phase I/II trial is studying the side effects and best dose of temozolomide when given with peripheral stem cell transplantation and to see how well they work in treating children with newly diagnosed malignant glioma or recurrent CNS tumors or other 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 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Testicular Germ Cell Tumor | Testicular Germ Cell Tumor |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| filgrastim | Biological | Filgrastim | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Overall response at 12 months
- measure
- Disease-free survival at 12 months
Secondary outcomes (2)
- measure
- Toxicity by NCI Common Toxicity Criteria v. 3.0 at 12 months
- measure
- Engraftment related to autologous marrow or peripheral blood stem cell transplantation at 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed newly diagnosed malignant glioma or recurrent malignant CNS tumor of any pathology OR * Histologically confirmed non-CNS tumor * Recurrent soft tissue sarcomas (e.g., rhabdomyosarcoma) * Recurrent or resistant neuroblastoma * Recurrent Wilm's tumor * Recurrent Ewing's sarcoma * Recurrent primitive neuroectodermal tumors * Recurrent nasopharyngeal carcinoma * Recurrent germ cell tumor * Expected cure rate less than 10% with standard therapy * Measurable and/or active disease * History of bone marrow tumor infiltration with or without mass lesions or isolated abnormal CSF cytology as only evidence of recurrent disease allowed if complete response was first achieved with primary conventional therapy PATIENT CHARACTERISTICS: Age: * 18 and under Performance status: * Karnofsky 70-100% OR * Lansky 70-100% Life expectancy: * Greater than 8 weeks Hematopoietic: * Reasonably cellular bone marrow (greater than 15% cellularity on biopsy) * Absolute neutrophil count greater than 1,000/mm\^3 * Platelet count greater than 75,000/mm\^3 Hepatic: * Bilirubin less than 2.0 mg/dL * SGPT less than 120 U/L Renal: * Creatinine less than 1.5 mg/dL Cardiovascular: * Systolic fraction or ejection fraction at least 80% predicted for age by echocardiogram Pulmonary: * CVC or DLCO at least 60% predicted for age OR clearance from pulmonologist Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No active infection * Able to tolerate vigorous hydration schedule PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent white blood cell transfusion * No other concurrent hematopoietic growth factors Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy * No other concurrent cytotoxic drugs (systemic or intrathecal) Endocrine therapy: * Concurrent corticosteroids allowed Radiotherapy: * See Disease Characteristics * At least 1 week since prior radiotherapy Surgery: * At least 1 week since prior surgery Other: * No other concurrent investigational agents
References
Publications (0)
Data not yet available