Status:
COMPLETED
Study of Single Agent Perifosine for Recurrent Pediatric Solid Tumors
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
University of Wisconsin, Madison
Duke University
Conditions:
Solid Tumors
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to test whether perifosine- a drug that inhibits the protein AKT, and has had some success in the treatment of adult cancers- is safe and effective in treating cancer. The...
Eligibility Criteria
Inclusion
- Any solid tumor that failed standard therapy.
- Patient must have evidence for tumor by CT, MRI, PET scan, MIBG scan, serum markers, or tissue sampling.
- Age ≤ 21 years.
- Karnofsky/Lansky performance status ≥ 50% (Karnofsky score for age\> 16 years and Lansky score for age ≤ 16 years)
- ANC≥ 1000 at least 24 hours off GCSF
- Platelets ≥ 75k at least one week off platelet transfusions
- Hg≥ 8g/dL at least one week off PRBC transfusion
- AST ≤ 3 x the upper limit of normal
- ALT ≤ 3 x the upper limit of normal
- Total bilirubin ≤ 2.0 mg/dl
- serum creatinine ≤ 1.5 x the upper limit of normal for age, or calculated creatinine clearance or nuclear GFR ≥ 70 ml/min/1.73 m2.
- ≥ 3 weeks since last non-nitrosourea chemotherapy
- ≥ 6 weeks since last nitrosoureas
- ≥ 4 weeks since last RT
- Patients must agree to practice adequate contraception. Females of childbearing potential must have a negative B-HCG pregnancy test documented within 14 days prior to drug initiation. Females must not be breast feeding.
- Patients must be able to swallow tablets whole
Exclusion
- Pregnancy
- Patients must not have active infection or serious intercurrent medical illness.
- HIV-Positive patients receiving combination anti-retroviral therapy are excluded from the study due to possible retro-viral drug interactions. HIV testing not required.
- Patients must not be taking EIAEDs. If patients were previously EIAEDs that have been discontinued, patients must have been off the agent for at least 2 weeks prior to registration.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2017
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00776867
Start Date
October 1 2008
End Date
July 1 2017
Last Update
August 1 2017
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065