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| Sponsor: | Children's Hospital of Philadelphia |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00068302 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Drug: sirolimus |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase I Trial Of Sirolimus In Relapsed/Refractory Leukemia And Non-Hodgkin's Lymphoma |
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2003 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Acute lymphoblastic leukemia (ALL) OR acute myeloid leukemia (AML)
Non-Hodgkin's lymphoma (NHL)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Creatinine based on age, as follows:
Cardiovascular
Other
No uncontrolled active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent administration of any of the following:
Contacts and Locations| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Susan Rheingold, MD 215-590-2801 rheingold@email.chop.edu | |
| Study Chair: | Susan Rheingold, MD | Children's Hospital of Philadelphia |
More Information
| Study ID Numbers: | CDR0000321392, CHP-755, CHP-IRB-2002-12-3086 |
| Study First Received: | September 10, 2003 |
| Last Updated: | July 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00068302 History of Changes |
| Health Authority: | Unspecified |
|
recurrent childhood lymphoblastic lymphoma recurrent childhood small noncleaved cell lymphoma recurrent childhood large cell lymphoma recurrent childhood acute myeloid leukemia recurrent childhood acute lymphoblastic leukemia |
|
Sirolimus Anti-Infective Agents Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents |
Pharmacologic Actions Anti-Bacterial Agents Leukemia Lymphatic Diseases Neoplasms Antifungal Agents Therapeutic Uses Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |