Study of Single Agent Perifosine for Recurrent Pediatric Solid Tumors



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 21
Updated:8/2/2017
Start Date:October 2008
End Date:July 2017

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Phase I Study of Single Agent Perifosine for Recurrent Pediatric Solid Tumors

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.


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.
We found this trial at
1
site
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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mi
from
New York, NY
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