Sirolimus in Treating Young Patients With Relapsed or Refractory Acute Leukemia or Non-Hodgkin's Lymphoma

Phase 1

Terminated

• Conditions: Leukemia; Lymphoma
• Interventions: Drug: sirolimus

• Registration Number: NCT00068302
• Lead Sponsor: Children's Hospital of Philadelphia

Brief Summary

RATIONALE: Drugs used in chemotherapy such as sirolimus use 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 sirolimus in treating young patients with relapsed or refractory acute leukemia or non-Hodgkin's lymphoma.

Detailed Description

OBJECTIVES:

* Determine the maximum tolerated dose of sirolimus in pediatric patients with refractory or relapsed acute leukemia or non-Hodgkin's lymphoma.

* Determine the dose-limiting toxic effects of this drug in these patients.

* Determine the trough levels produced by this drug in these patients.

* Determine the anti-leukemia/lymphoma activity of this drug in these patients.

OUTLINE: This is an open-label, dose-escalation study.

Patients receive oral sirolimus once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of sirolimus 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 for survival.

PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 2 years.

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2003-09-10
• Study First Submitted QC: 2003-09-10
• Study First Posted: 2003-09-11
• Primary Completion: 2009-04
• Status Verified: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2015-03-11
• Last Update Posted: 2015-03-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sirolimus	sirolimus	This is a dose escalation study including 4-dose levels. Subjects will receive a one-time loading dose of sirolimus on day 0, time 0. Subsequent dosing at the assigned dose level will start 24 hours following the initial loading dose

Primary Outcome Measures

Name	Time	Method
Toxicity as assessed by Common Toxicity Criteria (CTC) toxicity criteria after the first course of treatment	within 21 days following administration of sirolimus	Subjects will be assessed for toxicity on days 3, 7 and 21

Secondary Outcome Measures

Name	Time	Method
Response as assessed by radiologic scans after each course of treatment	day 21	Response will be assessed on day 21 of cycle 1

Trial Locations

Locations (1)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States