Clinical trial · Interventional
Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas
Phase I Study of Concurrent Cereport and Carboplatin With Radiation Therapy for Children With Newly-Diagnosed Brain Stem Gliomas
NCT00005602CI-TRIAL-00013832completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as carboplatin and lobradimil may make the tumor cells more sensitive to radiation therapy. PURPOSE: Phase I trial to study the effectiveness of combining radiation therapy with carboplatin and lobradimil in treating children who have newly diagnosed brain stem gliomas.
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 |
|---|---|---|---|
| Brain and Central Nervous System Tumors | Central Nervous System Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| cereport | Drug | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 20 Days
- interventionNames
- Drug: carboplatin
- Drug: cereport
- Radiation: radiation therapy
- type
- EXPERIMENTAL
- label
- Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 25 Days
- interventionNames
- Drug: carboplatin
- Drug: cereport
- Radiation: radiation therapy
- type
- EXPERIMENTAL
- label
- Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 30 Days
- interventionNames
- Drug: carboplatin
- Drug: cereport
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Newly diagnosed diffuse, intrinsic brain stem gliomas * Measurable disease * No disseminated disease at sites other than brain stem * No neurofibromatosis * Treatment must begin within 31 days of diagnosis * Date of diagnosis will be considered date of surgery in patients undergoing surgical biopsy PATIENT CHARACTERISTICS: Age: * 3 to 21 Performance status: * Karnofsky 50-100% (over 10 years of age) * Lansky 50-100% (10 years of age and under) Life expectancy: * At least 2 months Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * SGPT no greater than 2.5 times ULN (4.0 times ULN with antiepileptic or steroid medications) Renal: * Creatinine less than ULN for age OR * Creatinine clearance or glomerular filtration rate greater than 80 mL/min Other: * No history of severe allergic reaction to any platinum-containing compound * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent growth factors during therapy with carboplatin Chemotherapy * Not specified Endocrine therapy * Prior corticosteroids for brain stem glioma are allowed Radiotherapy * Not specified Surgery * Prior surgery for brain stem glioma is allowed Other * At least 24 hours since any of the following medications: * Vasodilating compounds * Angiotensin-converting enzyme inhibitors * Calcium channel blockers * Beta blockers * No other prior therapy for brain stem glioma
References
Publications (0)
Data not yet available
No reference posted for this study.