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
Sponsor: Children's Hospital of Philadelphia
Terminated
Recruiting/enrolling participants halted prematurely but potentially will resume
A PHASE1 clinical study on Leukemia and Lymphoma, this trial is terminated or withdrawn. The trial is conducted by Children's Hospital of Philadelphia and has accumulated 6 data snapshots since 2003. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)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.
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.
Status Flow
Change History
6 versions recorded-
Jan 2026 — Present [monthly]
Terminated PHASE1
-
Sep 2024 — Present [monthly]
Terminated PHASE1
-
Jul 2024 — Sep 2024 [monthly]
Terminated PHASE1
-
Jan 2021 — Jul 2024 [monthly]
Terminated PHASE1
-
Jun 2018 — Jan 2021 [monthly]
Terminated PHASE1
▶ Show 1 earlier version
-
Jan 2017 — Jun 2018 [monthly]
Terminated PHASE1
First recorded
Jan 2003
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Children's Hospital of Philadelphia
- National Childhood Cancer Foundation
- The Leukemia and Lymphoma Society
For direct contact, visit the study record on ClinicalTrials.gov .