Study of Single Agent Perifosine for Recurrent Pediatric Solid Tumors

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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 investigators want to find out what effects, good and/or bad, it has on the patient and the cancer. The investigators are testing different dose schedules of perifosine and the patient will be asked to partake in one of the dose schedules.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: AEterna Zentaris; Duke University; University of Wisconsin, Madison

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.