Clinical trial · Interventional
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
NCT00068302CI-TRIAL-00017122terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruiting/enrolling participants halted prematurely but potentially will resume
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sirolimus | Drug | Sirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sirolimus
- description
- 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
- interventionNames
- Drug: sirolimus
Primary outcomes (1)
- measure
- Toxicity as assessed by Common Toxicity Criteria (CTC) toxicity criteria after the first course of treatment
- timeFrame
- within 21 days following administration of sirolimus
- description
- Subjects will be assessed for toxicity on days 3, 7 and 21
Secondary outcomes (1)
- measure
- Response as assessed by radiologic scans after each course of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of 1 of the following:
* Acute lymphoblastic leukemia (ALL) OR acute myeloid leukemia (AML)
* At least 25% blasts in the bone marrow
* Recurrent or refractory disease
* Non-Hodgkin's lymphoma (NHL)
* Second or greater relapse as determined by physical or radiological evidence
* Disease for which there is no known curative therapy
PATIENT CHARACTERISTICS:
Age
* 21 and under
Performance status
* Karnofsky 50-100% (patients over 10 years of age)
* Lansky 50-100% (patients 10 years of age and under)
Life expectancy
* At least 4 weeks
Hematopoietic
* Absolute neutrophil count at least 1,000/mm\^3\*
* Platelet count at least 75,000/mm\^3 (transfusion independent)\*
* Hemoglobin at least 8.0 g/dL (may receive red blood cells (RBC) transfusions)\* NOTE: \*Patients with ALL, AML, and NHL with tumor metastatic to bone marrow, with granulocytopenia, anemia, and/or thrombocytopenia are eligible, but will not be evaluable for hematological toxicity
Hepatic
* Bilirubin no greater than 1.5 times normal
* alanine aminotransferase (ALT) no greater than 5 times normal
* Albumin at least 2 g/dL
Renal
* Creatinine based on age, as follows:
* No greater than 0.8 mg/dL (5 years of age and under)
* No greater than 1.0 mg/dL (6 to 10 years of age)
* No greater than 1.2 mg/dL (11 to 15 years of age)
* No greater than 1.5 mg/dL (over 15 years of age) OR
* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
Cardiovascular
* Shortening fraction at least 28% by echocardiogram OR
* Ejection fraction at least 50% by gated radionuclide
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to ingest oral medication
* No known allergy to sirolimus, tacrolimus, or other mammalian target of rapamycin (mTOR) inhibitors
* No uncontrolled active infection
* Fungal disease must be stable for at least 2 weeks prior to study entry
* Documented negative blood cultures prior to study entry for patients with bacteremia
* No active graft-versus-host disease
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Recovered from prior immunotherapy
* More than 1 week since prior hematopoietic growth factors except for epoetin alfa
* At least 7 days since prior biologic antineoplastic agents
* At least 3 months since prior bone marrow or stem cell transplantation
Chemotherapy
* Recovered from all prior chemotherapy
* More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas)
* Prior hydroxyurea within the past 2 weeks is allowed provided peripheral blast count has been stable or rising for at least 3 days
Endocrine therapy
* Prior corticosteroids within the past 2 weeks are allowed provided peripheral blast count has been stable or rising for at least 3 days
Radiotherapy
* Recovered from prior radiotherapy
* At least 2 weeks since prior local palliative radiotherapy
* At least 4 weeks since prior craniospinal radiotherapy or radiation to the pelvis of 50% or more
* At least 4 weeks since prior substantial bone marrow radiotherapy
* No concurrent radiotherapy, except for emergent situations or persistent extramedullary disease with resolution of bone marrow disease
Surgery
* Not specified
Other
* No other concurrent investigational antineoplastic drugs
* No concurrent administration of any of the following:
* Ketoconazole
* Tacrolimus
* Cyclosporine
* Rifampin
* DiltiazemReferences
Publications (0)
Data not yet available
No reference posted for this study.