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

Phase 1
21 Years
Open (Enrolling)
Solid Tumors

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Trial Information

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

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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) of perifosine monotherapy in children with cancer

Outcome Time Frame:

conclusion of the study

Safety Issue:


Principal Investigator

Ira Dunkel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

October 2008

Completion Date:

October 2013

Related Keywords:

  • Solid Tumors
  • Pediatric
  • solid tumors
  • Pediatric solid tumors
  • 08-091
  • Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021