Trial of Sirolimus and Methotrexate in Relapsed/Refractory Lymphoblastic Leukemia and Lymphoma
Completed · Phase 2
Conditions studied: Cancer, Leukemia, Lymphoma
In brief
This is a phase 2 study looking at efficacy and toxicity of oral sirolimus in combination with oral methotrexate in children with refractory/relapsed ALL or NHL. Secondary objectives include characterizing the trough levels produced by administration of oral sirolimus in children with refractory/relapsed ALL/NHL and to evaluate the effect of sirolimus on intracellular targets related to mTOR inhibition.
Key facts
- Study ID
- NCT01162551
- Run by
- Children's Hospital of Philadelphia
- People needed
- 5
- Starts
- 2010-05-01
- Expected to finish
- 2017-02-01
- Last updated by the study team
- 2019-08-06
Who can join
Age: any, up to 25. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients </= 25 years of age, at time of enrollment, with second or greater relapse of ALL or NHL. For ALL must have histologic diagnosis with >10% blasts in the marrow and for lymphoblastic lymphoma or peripheral T-cell lymphoma must have radiologic or physical evidence of recurrence.
- Lansky > 50% or Karnofsky > 50%
- Negative Pregnancy Test
- Creatinine clearance or radioisotope GFR > 70ml/min/m2 OR serum creatinine based on age /gender
- Pulse ox >94%
- Total Bilirubin <1.5 x normal for age
- ALT < 5 x normal for age
- Albumin > 2g/dL
- Shortening fraction by echo > 28% OR ejection fraction > 50% by gated radionuclide study
You may not qualify if…
- Patient has known allergies to sirolimus,FK-506 or mTOR inhibitors
- Patient is taking other investigational anti-neoplastic drugs
- Patient received no myelosuppressive chemo within 14 days
- < 14 days have elapsed since local palliative XRT (small port) < 28 days since prior craniospinal XRT or 50% radiation of pelvis <28 days if other substantial BM radiation
- Hematopoietic growth factors within 7 days of entry (except erythropoietin.)
- Patient has taken any biologic agents within 14 days
- Post BMT/SCT - evidence of active GVHD, at least > 3 months must have elapsed
- Patient has uncontrolled infection (if patients with fungal disease, stable for < 14 days and patients with bacteremia without negative blood culture
- Existing non-hematologic toxicities > grade 2
- Use of steroids or hydroxyurea is permitted upto 14 days prior to entry.
Where it is running
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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