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Tariquidar Plus Chemotherapy in Treating Children With Relapsed or Refractory Solid Tumors

2014-08-27 03:56:46 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin, and vinorelbine, work in different ways to stop tumor cells from dividing so they stop growing or die. Tariquidar may increase the effectiveness of chemotherapy by making tumor cells more sensitive to the drug.

PURPOSE: This phase I trial is studying the effectiveness of tariquidar plus chemotherapy in treating children who have relapsed or refractory solid tumors.

Description

OBJECTIVES:

- Determine the toxic effects and tolerability of tariquidar combined with docetaxel, doxorubicin, or vinorelbine in children with relapsed or refractory solid tumors.

- Determine the maximum tolerated dose of tariquidar in this patient population.

- Determine the pharmacokinetics of tariquidar alone and in combination with docetaxel, doxorubicin, or vinorelbine in this patient population.

OUTLINE: This is a dose-escalation study of tariquidar.

Patients receive tariquidar IV over 30 minutes on days -1 and 1 of course 1 and on day 1 of all subsequent courses. Patients also receive one of the following: doxorubicin IV over 15 minutes on day 1; vinorelbine IV over 10 minutes on days 1 and 8; or docetaxel IV over 60 minutes on day 1. Patients receiving doxorubicin or docetaxel also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 3 and continuing until blood counts recover. Patients receiving vinorelbine also receive G-CSF SC beginning on day 10 and continuing until blood counts recover. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of tariquidar until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. An additional 18 patients (at least 3 under age 12 and at least 3 who are age 12 and older) are treated at the MTD. Intrapatient dose escalation may take place for patients in cohorts 1 and 2 after 2 courses of treatment.

Patients undergo blood collection periodically for pharmacokinetic and pharmacodynamic studies.

Patients are followed every 6 weeks for 1 year and then every 12 weeks during study treatment.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Study Design

Primary Purpose: Treatment

Conditions

Brain and Central Nervous System Tumors

Intervention

filgrastim, docetaxel, doxorubicin hydrochloride, tariquidar, vinorelbine ditartrate, pharmacological study

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda
Maryland
United States
20892-1182

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:56:46-0400

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