Status:
COMPLETED
Trial of Sirolimus and Methotrexate in Relapsed/Refractory Lymphoblastic Leukemia and Lymphoma
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
The Leukemia and Lymphoma Society
Conditions:
Cancer
Leukemia
Eligibility:
All Genders
Up to 25 years
Phase:
PHASE2
Brief Summary
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 characte...
Detailed Description
At present children who have bone marrow or combined bone marrow and extramedullary relapses of acute leukemia while on therapy have 5-20% of long-term survival. Newer, targeted agents need to be iden...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01162551
Start Date
May 1 2010
End Date
February 1 2017
Last Update
August 6 2019
Active Locations (1)
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1
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104