Clinical trial · Interventional
Lobradimil and Carboplatin in Treating Children With Brain Tumors
A Phase II Trial of Intravenous Cereport (RMP-7) and Carboplatin in Childhood Brain 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. Lobradimil may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of carboplatin and lobradimil in treating children with brain tumors that have not responded to previous treatment.
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 | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| lobradimil | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed childhood brain tumor that is recurrent or refractory or for which no standard chemotherapy exists * High-grade glioma (anaplastic astrocytoma or glioblastoma multiforme) (High-grade glioma stratum closed to accrual as of 01/08/2002) * Low-grade glioma * Medulloblastoma/primitive neuroectodermal tumor (PNET) * Ependymoma * Brainstem tumor or visual pathway glioma (with radiographic evidence only) (Brainstem glioma stratum closed to accrual as of 12/21/2000) * Evidence of recurrent or progressive disease after front-line therapy documented as an increase in tumor size or appearance of new lesion(s) on MRI * Patients who did not previously receive radiotherapy as front-line therapy are eligible at time of second recurrence if the first recurrence was treated with radiotherapy only * Measurable disease in at least 2 dimensions by MRI * Diffuse meningeal involvement not considered measurable if it is the only site of disease * Disease must not be limited to the meninges * No metastases outside of the CNS PATIENT CHARACTERISTICS: Age: * 21 and under at diagnosis Performance status: * ECOG 0-2 Life expectancy: * At least 8 weeks Hematopoietic: * Absolute granulocyte count at least 1,000/mm\^3 * Hemoglobin at least 8.0 g/dL (transfusion allowed) * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * SGPT no greater than 2.5 times ULN * No significant hepatic illness Renal: * Creatinine within limits as defined below by age: * Age 5 and under: less than 1.2 mg/dL * Age 6 to 10: less than 1.5 mg/dL * Age 11 to 15: less than 1.8 mg/dL * Age 16 and over: less than 2.4 mg/dL Cardiovascular: * No significant cardiac illness Pulmonary: * No significant pulmonary illness Other: * No significant systemic illness or organ dysfunction that would preclude study * No allergic reaction to platinum-containing compounds * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 72 hours since filgrastim (G-CSF) * No concurrent biologic therapy for brain tumor Chemotherapy: * See Disease Characteristics * No prior carboplatin or lobradimil * No more than 1 prior chemotherapy regimen for high-grade glioma, low-grade glioma, or ependymoma * No more than 2 prior chemotherapy regimens for medulloblastoma/PNET * At least 4 weeks since prior nitrosoureas (2 weeks if also received stem cell/bone marrow rescue) * At least 2 weeks since any other prior myelosuppressive chemotherapy and recovered * No other concurrent chemotherapy for brain tumor Endocrine therapy: * Concurrent corticosteroids for management of tumor-related edema allowed Radiotherapy: * See Disease Characteristics * At least 6 weeks since prior radiotherapy to measurable disease and recovered * No concurrent radiotherapy for brain tumor Surgery: * No concurrent surgery except for ventriculo-peritoneal shunt placement or revision Other: * At least 24 hours since prior vasodilating agents, angiotensin-converting enzyme inhibitors, calcium channel blockers, or beta-blockers
References
Publications (3)
- BACKGROUNDWarren KE, Patel MC, Aikin AA, Widemann B, Libucha M, Adamson PC, Neuwirth R, Benziger D, O'Toole T, Ford K, Patronas N, Packer RJ, Balis FM. Phase I trial of lobradimil (RMP-7) and carboplatin in children with brain tumors. Cancer Chemother Pharmacol. 2001 Oct;48(4):275-82. doi: 10.1007/s002800100356. PMID 11710627
- BACKGROUNDWarren KE, Patel MC, Adamson PC, et al.: Phase I trial of RMP-7 and carboplatin in pediatric patients with brain tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A-764, 1998.
- RESULTWarren K, Jakacki R, Widemann B, Aikin A, Libucha M, Packer R, Vezina G, Reaman G, Shaw D, Krailo M, Osborne C, Cehelsky J, Caldwell D, Stanwood J, Steinberg SM, Balis FM. Phase II trial of intravenous lobradimil and carboplatin in childhood brain tumors: a report from the Children's Oncology Group. Cancer Chemother Pharmacol. 2006 Sep;58(3):343-7. doi: 10.1007/s00280-005-0172-7. Epub 2006 Jan 12. PMID 16408203