NCT00012181

Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas

A PHASE I STUDY OF FLAVOPIRIDOL (NSC# 649890; IND# 46211) IN PATIENTS WITH RELAPSED OR REFRACTORY PEDIATRIC SOLID TUMORS OR LYMPHOMAS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Recurrent Childhood Brain Stem Glioma
• Recurrent Childhood Cerebellar Astrocytoma
• Recurrent Childhood Cerebral Astrocytoma
• Recurrent Childhood Ependymoma
• Recurrent Childhood Large Cell Lymphoma
• Recurrent Childhood Liver Cancer
• Recurrent Childhood Lymphoblastic Lymphoma
• Recurrent Childhood Malignant Germ Cell Tumor
• Recurrent Childhood Medulloblastoma
• Recurrent Childhood Rhabdomyosarcoma
• Recurrent Childhood Small Noncleaved Cell Lymphoma
• Recurrent Childhood Soft Tissue Sarcoma
• Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor
• Recurrent Childhood Visual Pathway and Hypothalamic Glioma
• Recurrent Childhood Visual Pathway Glioma
• Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
• Recurrent Neuroblastoma
• Recurrent Osteosarcoma
• Recurrent Retinoblastoma
• Recurrent Wilms Tumor and Other Childhood Kidney Tumors
• Recurrent/Refractory Childhood Hodgkin Lymphoma
• Unspecified Childhood Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	alvocidib	Given IV
OTHER	pharmacological study	Correlative studies

Timeline

• Start date: 2001-04-01
• Primary completion: 2005-01-01
• First posted: 2003-01-27
• Last updated: 2013-07-02

Locations

1 site across 1 country: United States