A Phase 1 interventional study of alvocidib and pharmacological study in Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Cerebellar Astrocytoma and Recurrent Childhood Cerebral Astrocytoma, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2013-07-02.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase I trial to study the effectiveness of flavopiridol in treating children who have relapsed or refractory solid tumors or lymphoma.
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of flavopiridol in children with relapsed or refractory solid tumors or lymphomas.
II. Determine the toxic effects and pharmacokinetics of this drug in these patients.
III. Determine the antitumor activity of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of flavopiridol 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.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 18 months.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 30 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma 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.
Inclusion Criteria:
Histologically confirmed relapsed or refractory solid tumor or lymphoma including:
Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: alvocidib · Other: pharmacological study
Given IV
Also known as: FLAVO, flavopiridol, HMR 1275, L-868275
Correlative studies
Also known as: pharmacological studies
MTD defined as the dose at which fewer than one-third of patients experience DLT assessed using Common Toxicity Criteria version 2.0
Time frame: Day 21
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)