Trials / Terminated
TerminatedNCT00068302
Sirolimus in Treating Young Patients With Relapsed or Refractory Acute Leukemia or Non-Hodgkin's Lymphoma
A Phase I Trial Of Sirolimus In Relapsed/Refractory Leukemia And Non-Hodgkin's Lymphoma
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Children's Hospital of Philadelphia · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | sirolimus | 3-6 subjects will be enrolled into each dose level |
Timeline
- Start date
- 2003-01-01
- Primary completion
- 2009-04-01
- Completion
- 2013-07-01
- First posted
- 2003-09-11
- Last updated
- 2015-03-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00068302. Inclusion in this directory is not an endorsement.