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Sponsors and Collaborators: |
National Cancer Institute (NCI) Children's Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00019422 |
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.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: carboplatin Drug: lobradimil |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Trial of Intravenous Cereport (RMP-7) and Carboplatin in Childhood Brain Tumors |
Study Start Date: | March 1998 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients are stratified according to histology (high-grade glioma vs low-grade glioma vs brainstem or visual pathway glioma vs medulloblastoma/primitive neuroectodermal tumor vs ependymoma). (Brainstem glioma stratum closed to accrual as of 12/21/2000.) (High-grade glioma stratum closed to accrual as of 01/08/2002.)
Patients receive carboplatin IV over 15 minutes and lobradimil IV over 10 minutes on days 1 and 2. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 12, patients may receive additional courses at the discretion of the institutional investigator.
Quality of life is assessed at baseline and then every 3 courses.
Patients are followed every 3 months for 1 year or until evidence of disease progression or initiation of a new therapy.
PROJECTED ACCRUAL: A maximum of 146 patients will be accrued for this study within 2-4 years.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed childhood brain tumor that is recurrent or refractory or for which no standard chemotherapy exists
Measurable disease in at least 2 dimensions by MRI
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Creatinine within limits as defined below by age:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Katherine Warren, MD | NCI - Pediatric Oncology Branch |
Study Chair: | Regina Jakacki, MD | Children's Hospital of Pittsburgh |
Study ID Numbers: | CDR0000066169, NCI-98-C-0074H, CCG-09716, ALK-01-041, NCI-T98-0011, COG-C09716 |
Study First Received: | July 11, 2001 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00019422 History of Changes |
Health Authority: | United States: Federal Government |
childhood low-grade cerebral astrocytoma recurrent childhood supratentorial primitive neuroectodermal tumor recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma |
recurrent childhood medulloblastoma untreated childhood visual pathway and hypothalamic glioma recurrent childhood visual pathway and hypothalamic glioma recurrent childhood ependymoma |
Neuroectodermal Tumors, Primitive Astrocytoma Brain Tumor, Childhood Central Nervous System Diseases Carboplatin Central Nervous System Neoplasms Brain Diseases Ependymoma |
Recurrence Brain Neoplasms Neuroectodermal Tumors Medulloblastoma Neuroepithelioma Glioma Nervous System Neoplasms |
Brain Neoplasms Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Nervous System Diseases |
Central Nervous System Diseases Carboplatin Central Nervous System Neoplasms Brain Diseases Pharmacologic Actions Nervous System Neoplasms |