Status:
TERMINATED
O6-Benzylguanine-Mediated Tumor Sensitization With Chemoprotected Autologous Stem Cell in Treating Patients With Malignant Gliomas
Lead Sponsor:
Fred Hutchinson Cancer Center
Conditions:
Glioblastoma
Gliosarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This phase I/II trial studies the side effects and best dose of temozolomide when given together with radiation therapy, carmustine, O6-benzylguanine, and patients' own stem cell (autologous) transpla...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the safety and feasibility of infusing autologous granulocyte colony-stimulating factor (G-CSF) (filgrastim) mobilized stem cells transduced with a Phoenix-gibbon ape...
Eligibility Criteria
Inclusion
- Patients with glioblastoma multiforme or gliosarcoma
- The patient or legal guardian must be able to comprehend the informed consent form and sign prior to patient enrollment
- Karnofsky performance status at time of study entry must be \>= 70%
- Life expectancy of \>= 3 months
- Patients must agree to undergo repeat clinical neurological examinations and brain magnetic resonance imaging (MRI) with appropriate contrast after every other cycle of chemotherapy
- White blood cell (WBC) \> 3000/ul
- Absolute neutrophil count (ANC) \> 1500/ul
- Platelets \> 100,000/ul
- Hemoglobin \> 10 gm/100ml
- Total and direct bilirubin \< 1.5 times upper limit of laboratory normal
- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =\< 3 times upper limit of laboratory normal
- Alkaline phosphatase =\< 3 times upper limit of laboratory normal
- Blood urea nitrogen (BUN) \< 1.5 times upper limit of laboratory normal
- Serum creatinine \< 1.5 times upper limit of laboratory normal
- Left ventricular ejection fraction (LVEF) \>= 40%, however, subjects with a LVEF in the range of 40-49% should have cardiology clearance prior to intervention
- MGMT promoter methylation analysis of surgically resected tumor or tumor biopsy must demonstrate an unmethylated or hypomethylated MGMT promoter status
Exclusion
- Patients with cardiac insufficiency and a LVEF of \< 40%; history of coronary artery disease or arrhythmia, which has required or requires ongoing treatment
- Patients with active pulmonary infection and/or pulse oximetry \< 90% and a corrected diffusion capacity of the lung for carbon monoxide (DLCO) \< 70% of predicted
- Active systemic infection
- Patients who are human immunodeficiency virus (HIV) positive
- Pregnant or lactating women; a beta-human chorionic gonadotropin (HCG) level will be obtained from women of childbearing potential; fertile men and women should use effective contraception
- Previous chemotherapy for any malignancy including temozolomide, dacarbazine (DTIC) or prior nitrosourea
- Diabetes mellitus
- Bleeding disorder
- Methylated or hypermethylated MGMT promoter status within tumor tissue
- Medical or psychiatric condition which in the opinion of the protocol chairman would compromise the patient's ability to tolerate this protocol
- Prior interstitial radiotherapy, stereotactic or gamma knife surgery or implanted BCNU-wafers
Key Trial Info
Start Date :
February 25 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00669669
Start Date
February 25 2009
End Date
January 20 2021
Last Update
May 18 2022
Active Locations (1)
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1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109