A Phase 1 interventional study of temozolomide in Leukemia, sponsored by Children's Oncology Group. Completed at 16 sites in 2 countries. Open to participants aged 1 Year to 21 Years. Per ClinicalTrials.gov, last updated 2014-02-20.
Sponsored by Children's Oncology Group · Phase 1, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide in treating young patients with refractory or recurrent leukemia.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 18-24 months.
5,441 studies on the registry are indexed under Leukemia; 637 are open to participants now.
This study's enrollment of 16 is below the median of 38 across 4,248 interventional studies indexed under Leukemia.
Browse Leukemia studies →Children's Oncology Group is the lead sponsor of 436 studies on the registry; 34 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed leukemia of any of the following types:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
At least 3 months since prior stem cell transplantation
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Drug: temozolomide
Also known as: Temodar, NSC # 362856
Maximum tolerated dose and recommended phase II dose
Toxicity as assessed by CTCAE 3.0
Pharmacokinetics as assessed by CI, area under the curve (AUC), and half-life (T ½)
Antitumor activity
Biologic activity and mechanisms of resistance
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Children's Oncology Group