Clinical Trial: Ispinesib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Lymphoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A PHASE 1 STUDY OF ISPINESIB (SB-715992) IN PEDIATRIC PATIENTS WITH RELAPSED OR REFRACTORY SOLID TUMORS

Brief Summary: This phase I trial is studying the side effects and best dose of ispinesib in treating young patients with relapsed or refractory solid tumors or lymphoma. Drugs used in chemotherapy, such as ispinesib, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing

Detailed Summary:

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose and recommended phase II dose of ispinesib in pediatric patients with refractory solid tumors or lymphoma.

II. Define and describe the toxicities of ispinesib in these patients. III. Characterize the pharmacokinetics of ispinesib in these patients.

SECONDARY OBJECTIVES:

I. Define, preliminarily, the antitumor activity of ispinesib. II. Determine the relationship between CYP3A4 gene polymorphisms and pharmacokinetics in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive ispinesib IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of ispinesib 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 undergo blood and tumor sample collection periodically for pharmacokinetic and gene polymorphism correlative studies.

After completion of study therapy, patients are followed for 30 days.

Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Maximum tolerated dose, defined as the maximum dose at which fewer than one-third of patients experience DLT, graded according to NCI CTCAE version 3.0 [ Time Frame: Up to 28 days ]

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: August 10, 2006
Date Started: June 2006
Date Completion:
Last Updated: January 15, 2013
Last Verified: January 2013