Status:
COMPLETED
O6-Benzylguanine and Temozolomide in Treating Young Patients With Recurrent or Progressive Gliomas or Brain Stem Tumors
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well giving O6-benzylguanine together with temozolomide works in treating young patients with recurrent or progressive gliomas or brain stem tumors. Drugs used in c...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the sustained objective response rate to the combination of O6-benzylguanine and temozolomide in pediatric patients with recurrent or progressive high-grade gliomas a...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Tumor: Participants must have a high-grade glioma (including e.g. histologically confirmed anaplastic astrocytoma, glioblastoma multiforme, anaplastic oligodendroglioma, anaplastic ganglioma, gliosarcoma) or a brainstem tumor (histologic confirmation waived) with documentation of disease recurrence or progression after treatment with standard therapy. Participants must have bi-dimensionally measurable disease, defined as at least 1 lesion that can be measured in ≥ 2 dimensions
- Age: 21 years of age or less
- Performance status: Karnofsky 60-100% (for patients \> 16 years of age) or Lansky 60-100% (for patients ≤ 16 years of age)
- Life expectancy: Not specified
- Hematopoietic: Must have adequate bone marrow function defined as absolute neutrophil count \> 1,500/mm\^3, platelet count \> 100,000/mm\^3 (unsupported), hemoglobin \> 8 g/dL (may be supported), and absolute lymphocyte count ≥ 500/mm\^3
- Hepatic: Must have SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN), bilirubin ≤ 1.5 times ULN, and no overt hepatic disease
- Renal: Participants must have creatinine clearance ≥ 60 mL/min or creatinine based on age as follows: no greater than 0.8 mg/dL (for patients ≤ 5 years of age), no greater than 1.0 mg/dL (for patients 6 to 10 years of age), no greater than 1.2 mg/dL (for patients 11 to 15 years of age), or no greater than 1.5 mg/dL (for patients \> 15 years of age). There must be no overt renal disease
- Cardiovascular: Must have no overt cardiac disease
- Pulmonary: Must have no overt pulmonary disease
- Other: Female participants of childbearing potential must have a negative pregnancy test prior to study registration, and must avoid breast-feeding. Female and male participants of childbearing or child-fathering potential must use effective contraception
- Bone Marrow Transplant: Must be at least 6 months since prior allogeneic bone marrow transplantation and at least 3 months since prior autologous bone marrow or stem cell transplantation
- Growth Factors: Must be at least 2 weeks since prior colony-stimulating factors (e.g., filgrastim \[G-CSF\], sargramostim \[GM-CSF\], or erythropoietin)
- Prior Chemotherapy: Must have received last dose of myelosuppressive anticancer chemotherapy ≥ 3 weeks prior to study registration and ≥ 6 weeks for nitrosoureas. Must have received last dose of nonmyelosuppressive investigational agents or anticancer drugs ≥ 7 days prior to study registration. Participants who have received prior temozolomide are eligible
- Concurrent Endocrine Therapy: Concurrent corticosteroid therapy is allowed
- Prior Radiotherapy: Must have received last fraction of craniospinal irradiation and local irradiation to the primary tumor ≥ 12 weeks prior to study registration
- Prior Therapy-Other: Must have recovered from all prior therapy
- EXCLUSION CRITERIA
- Must not have history of severe toxicity (≥ grade 3) associated with temozolomide
- Must not be receiving other concurrent anticancer or investigational therapy
- Must not have history of hypersensitivity to dacarbazine, temozolomide, or polyethylene glycol (PEG)
- Must not have uncontrolled significant systemic illness including infection, or overt renal, hepatic, cardiac, or pulmonary disease
- Must not be HIV positive
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00275002
Start Date
February 1 2006
End Date
December 1 2010
Last Update
February 11 2022
Active Locations (11)
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1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
2
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010-2970
3
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States, 60614
4
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115