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Phase I Study of Perifosine With Temsirolimus for Recurrent Pediatric Solid Tumors

Phase 1
21 Years
Open (Enrolling)
Pediatric Solid Tumors

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Trial Information

Phase I Study of Perifosine With Temsirolimus for Recurrent Pediatric Solid Tumors

Inclusion Criteria:

- Any solid tumor that has failed standard therapy

- Patient must have evidence of tumor by CT, MRI, MIBG scan, serum markers, or tissue

- Age ≤ 21 years (age ≤ 35 years for biopsy proven medulloblastoma or neuroblastoma)

- 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 ≥ 100K at least one week off platelet transfusions

- Hg≥ 8g/dL at least one week off PRBC transfusion

- AST ≤ 2 x the upper limit of normal

- ALT ≤ 2 x the upper limit of normal

- Total bilirubin ≤ 2.0 mg/dl

- Patients must have cholesterol level < 350 mg/dl and triglycerides level < 400 mg/dl
because temsirolimus can induce hyperlipidemia.

- 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 serum B-HCG pregnancy test documented within 14 days
prior to registration. Females must not be breast feeding.

- Patients must be able to swallow tablets whole

- Patients that participated in the phase I single agent perifosine study for recurrent
pediatric solid tumors and did not experience a DLT are eligible to participate in
this study and can start ≥ 2 weeks since last dose of perifosine

- Patients that have been previously treated with an mTOR inhibitor can still enroll in
this trial as long as they did not experience a DLT in the single agent mTOR
inhibitor trial

Exclusion Criteria:

- Pregnancy

- Patients must not have an uncontrolled active infection.

- 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 on EIAEDs that have
been discontinued, patients must have been off the agent for at least 2 weeks prior
to registration.

- History of or known pulmonary hypertension or history of or known pneumonitis.

Type of Study:


Study Design:

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

Outcome Measure:

Maximum Tolerated Dose (MTD) of perifosine + temsirolimus combination in children with cancer.

Outcome Time Frame:

2 years

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:

January 2010

Completion Date:

January 2014

Related Keywords:

  • Pediatric Solid Tumors
  • pediatric
  • children
  • perifosine
  • temsirolimus
  • recurrent
  • progressive
  • 09-124
  • Neoplasms



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