A Phase 1 interventional study of L-alanosine in Brain and Central Nervous System Tumors, sponsored by National Cancer Institute (NCI). Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-01-13.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
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 and best dose of alanosine in treating patients with high-grade progressive or recurrent malignant gliomas.
OBJECTIVES:
OUTLINE: This is an open-label, nonrandomized, multicenter, dose-escalation study. Patients are stratified according to concurrent anticonvulsant drug use (drugs that induce hepatic metabolic enzymes vs drugs that cause modest or no induction of hepatic metabolic enzymes OR no anticonvulsant drug).
Patients receive alanosine (SDX-102) IV continuously for 5 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of SDX-102 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study therapy, patients are followed at 1 week and then every 2 months thereafter.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.
This study's planned enrollment of 18 is below the median of 32 across 1,065 interventional studies indexed under Glioma.
Browse Glioma studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed malignant glioma of 1 of the following types:
Progressive or recurrent disease after prior radiotherapy with or without chemotherapy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
This study is completed, as verified in Aug 2006. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)