Temozolomide and O6-Benzylguanine in Treating Children With Recurrent Brain Tumors

Completed · Phase 1

Conditions studied: Childhood Central Nervous System Germ Cell Tumor, Childhood Choroid Plexus Tumor, Childhood Craniopharyngioma, Childhood Ependymoblastoma, Childhood Grade I Meningioma, Childhood Grade II Meningioma, Childhood Grade III Meningioma, Childhood High-grade Cerebellar Astrocytoma, Childhood High-grade Cerebral Astrocytoma, Childhood Infratentorial Ependymoma, Childhood Low-grade Cerebellar Astrocytoma, Childhood Low-grade Cerebral Astrocytoma, Childhood Medulloepithelioma, Childhood Mixed Glioma, Childhood Oligodendroglioma, Childhood Supratentorial Ependymoma, Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma, Recurrent Childhood Ependymoma, Recurrent Childhood Medulloblastoma, Recurrent Childhood Pineoblastoma, Recurrent Childhood Subependymal Giant Cell Astrocytoma, Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor, Recurrent Childhood Visual Pathway and Hypothalamic Glioma

In brief

Phase I trial to study the safety of combining O6-benzylguanine with temozolomide in treating children who have recurrent or refractory brain tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. O6-benzylguanine may increase the effectiveness of temozolomide by making tumor cells more sensitive to the drug.

Key facts

Study ID: NCT00052780
Run by: National Cancer Institute (NCI)
People needed: 72
Starts: 2002-10-01
Last updated by the study team: 2013-09-30

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Recurrent or refractory pediatric brain tumors; a histopathologic diagnosis from either the initial presentation or at the time of recurrence is required for all but brain stem gliomas
Karnofsky or Lansky ≥ 60%
Life expectancy > 8 weeks
Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to study entry
Chemotherapy: No more than 2 previous chemotherapy/biologic therapy regimens; evidence of recovery from prior chemotherapy/biologic therapy; no myelosuppressive chemotherapy within 3 weeks (6 weeks if a nitrosourea agent) of study entry; patients who have received temozolomide are eligible if they have not received the drug in the past 3 months and did not experience any non-hematopoietic Grade 3/4 toxicity with prior temozolomide therapy
XRT: ≥ 3 months prior to study entry for craniospinal irradiation (≥ 18 Gy); ≥ 4 weeks for local radiation to primary tumor; and ≥ 2 weeks prior to study entry for focal irradiation to symptomatic metastatic sites
Bone Marrow Transplant: ≥ 6 months prior to study entry
Anti-convulsants: Patients will be eligible for this study even if they are receiving anti-convulsants
Growth factors: Off all colony forming growth factor(s) > 2 weeks prior to study entry (G-CSF, GM-CSF, Erythropoietin)
Dexamethasone: Patients who are receiving dexamethasone must be on a stable dose for at least 1 week prior to study entry
ANC > 1,000/μl
Platelets > 100,000/μl
Hemoglobin > 8g/dl
Patients may have bone marrow involvement by disease; platelet and Hgb counts must be transfusion independent
Creatinine ≤ 1.5 times institutional normal for age
Or GFR > 70 ml/min/1.73m\^2
Bilirubin ≤ upper limit of normal for age
SGPT (ALT) < and SGOT (AST) < 2.5X institutional normal
No overt renal, hepatic, cardiac or pulmonary disease
Female patients of childbearing potential must have negative serum or urine pregnancy test; patient must not be pregnant or breast-feeding; while no known teratogenic effects are known for O6-BG so far, there is little data to address this specifically; as such, the prudent approach is to exclude pregnant and breastfeeding patients until further data is available
Patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study
Signed informed consent according to institutional guidelines must be obtained and patients must begin therapy within seven (7) days of registration

You may not qualify if…

Patients must not be receiving any other anticancer or experimental drug therapy
Patients with a history of hypersensitivity to dacarbazine, temozolomide or polyethylene glycol are excluded

Where it is running

Pediatric Brain Tumor Consortium — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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