Status:
COMPLETED
Motexafin Gadolinium, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma
Lead Sponsor:
National Cancer Institute (NCI)
Collaborating Sponsors:
Radiation Therapy Oncology Group
Conditions:
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This phase I/II trial is studying the side effects and best dose of motexafin gadolinium when given together with temozolomide and radiation therapy and to see how well they work in treating patients ...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of motexafin gadolinium (MGd) when given concurrently with temozolomide and radiotherapy in patients with newly diagnosed supratentorial gl...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed glioblastoma multiforme (GBM) or gliosarcoma
- Newly diagnosed by surgical biopsy or excision within the past 5 weeks
- Supratentorial location, as determined by the following:
- Contrast-enhanced MRI performed preoperatively
- MRI performed postoperatively within 28 days prior to study entry (preferably within 72 hours of surgery)
- Postoperative scan not required if diagnosed by stereotactic biopsy and pre-operative MRI was performed
- No gliomas graded \< GBM
- No recurrent malignant gliomas
- No tumor foci detected below the tentorium or beyond the cranial vault
- No multifocal disease or leptomeningeal spread
- Zubrod performance status 0-1
- Neurologic function status 0-2
- Absolute neutrophil count ≥ 1,800 cells/mm\^3
- Platelet count ≥ 100,000 cells/mm\^3
- Hemoglobin ≥ 8 g/dL (transfusion allowed)
- BUN ≤ 25 mg/dL
- Creatinine ≤ 1.5 mg/dL
- Bilirubin ≤ 1.5 mg/dL
- ALT or AST ≤ 2 times upper limit of normal
- Fertile patients must use effective contraception during and for 2 months after completion of study treatment
- Negative pregnancy test
- Not pregnant or nursing
- No prior invasive malignancies, except for nonmelanomatous skin cancer and carcinoma in situ of the uterine cervix or bladder, unless disease-free for ? 3 years
- No severe, active comorbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
- Transmural myocardial infarction within the past 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at study entry
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to study entry
- Coagulation defects
- Known AIDS
- No prior allergic reaction to the study drugs
- No history of porphyria or G6PD deficiency
- No allergy to gadolinium or contraindications to MRI
- No other concurrent chemotherapy
- Recovered from effects of surgery or postoperative infection and other complications
- No prior systemic chemotherapy, including polifeprosan 20 with carmustine implant (Gliadel wafer), for the current GBM
- Prior chemotherapy for a different cancer allowed
- No prior radiotherapy to the head and neck (except for T1 glottic cancer) that would result in overlap of radiation therapy fields
- No prophylactic filgrastim (G-CSF) during the first course of study treatment
- No concurrent sargramostim (GM-CSF)
Exclusion
Key Trial Info
Start Date :
February 9 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2011
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00305864
Start Date
February 9 2006
End Date
March 15 2011
Last Update
March 5 2018
Active Locations (106)
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1
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36607
2
Arizona Oncology Services Foundation
Scottsdale, Arizona, United States, 85260
3
The University of Arizona Medical Center-University Campus
Tucson, Arizona, United States, 85724
4
East Bay Radiation Oncology Center
Castro Valley, California, United States, 94546