Status:
COMPLETED
Alanosine in Treating Patients With Progressive or Recurrent Malignant Gliomas
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as alanosine, use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase I trial is studying the side effects an...
Detailed Description
OBJECTIVES: * Determine the maximum tolerated dose of alanosine (SDX-102) with or without enzyme-inducible antiepileptic drugs (EIAEDs) in patients with methylthioadenosine phosphorylase (MTAP)-defic...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed malignant glioma of 1 of the following types:
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Glioblastoma multiforme
- Progressive or recurrent disease after prior radiotherapy with or without chemotherapy
- Low-grade glioma that progressed after prior radiotherapy with or without chemotherapy and is found to be high-grade glioma after biopsy allowed
- No more than 2 prior treatment regimens
- Measurable disease by CT scan or MRI
- Documented absence of methylthioadenosine phosphorylase (MTAP) on fixed tumor specimens
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Karnofsky 60-100%
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- Bilirubin ≤ 1.5 mg/dL
- Transaminases ≤ 4 times upper limit of normal
- Renal
- Creatinine ≤ 1.5 mg/dL
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception before, during, and for 4 weeks after study participation
- Mini mental state exam score of ≥ 15
- No psychological or sociological condition, addictive disorder, or family problem that would preclude study compliance
- No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast
- No concurrent serious infection or medical illness that would preclude study participation
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent prophylactic growth factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\])
- Chemotherapy
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- Endocrine therapy
- Must be maintained on a stable or lower corticosteroid regimen from the time of the baseline scan until the start of study treatment
- No concurrent steroids as antiemetics
- Radiotherapy
- See Disease Characteristics
- At least 3 months since prior radiotherapy
- Surgery
- Not specified
- Other
- Recovered from prior therapy
- More than 10 days since prior anticonvulsant drugs that induce hepatic metabolic enzymes
- No other concurrent investigational agents
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00075894
Start Date
March 1 2004
Last Update
January 13 2009
Active Locations (5)
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1
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
3
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
4
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202