Status:
COMPLETED
Tetra-O-Methyl Nordihydroguaiaretic Acid in Treating Patients With Recurrent High-Grade Glioma
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as tetra-O-methyl nordihydroguaiaretic acid (EM-1421), work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping ...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose (MTD) of tetra-O-methyl nordihydroguaiaretic acid (EM-1421) in patients with recurrent high-grade glioma. (Phase I) * Determine the respons...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed malignant glioma, including any of the following subtypes:
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Glioblastoma multiforme
- Progressive or recurrent disease after radiation therapy with or without chemotherapy
- Patients with a previous low-grade glioma that has progressed to biopsy-confirmed high-grade glioma after radiation therapy with or without chemotherapy are eligible
- Contrast-enhancing measurable disease by MRI or CT scan
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Absolute neutrophil count ≥ 1,500/mm³
- Hemoglobin ≥ 9 g/dL
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 1.5 mg/dL
- Bilirubin ≤ 1.5 mg/dL
- Transaminases ≤ 4 times upper limit of normal
- Prothrombin Time (PT)/partial thromboplastin time (PTT) /international normalized ratio (INR) normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 2 months after completion of study treatment
- Mini Mental State Exam score ≥ 15
- No serious concurrent infection or medical illness that would impair the ability to safely receive study treatment
- No other prior or concurrent malignancy within the past 5 years except for curatively treated carcinoma in situ or basal cell carcinoma of the skin
- No known sensitivity to any of the study medication components (i.e., polyethylene glycol \[PEG 300\] and 2-hydroxypropyl β-cyclodextrin)
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior therapy
- At least 3 months since prior radiation therapy
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- At least 2 weeks since prior Federal Drug Administration (FDA)-approved noncytotoxic therapy (e.g., celecoxib or thalidomide)
- At least 3 weeks since prior investigational noncytotoxic agents
- At least 10 days since prior anticonvulsant drugs that induce hepatic metabolic enzymes, including any of the following:
- Phenytoin
- Carbamazepine
- Phenobarbital
- Primidone
- Oxcarbazepine
- Ethosuximide
- No other concurrent therapy for this tumor, including systemic chemotherapy or radiation therapy
- Concurrent steroids allowed
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00404248
Start Date
January 1 2007
End Date
February 1 2012
Last Update
March 6 2019
Active Locations (9)
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1
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3410
2
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
3
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
4
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231