Perifosine With Temsirolimus for Recurrent Pediatric Solid Tumors

NCT01049841

Last updated date
Study Location
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pediatric Solid Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-21
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Any solid tumor that has failed standard therapy

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

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Pediatric Solid TumorsPerifosine With Temsirolimus for Recurrent Pediatric Solid Tumors
NCT01049841
  1. New York, New York
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Perifosine With Temsirolimus for Recurrent Pediatric Solid Tumors
Official Title  ICMJE Phase I Study of Perifosine With Temsirolimus for Recurrent Pediatric Solid Tumors
Brief Summary The purpose of this study is to test the safety and effectiveness of 2 drugs, perifosine in combination with temsirolimus in children with solid tumors. Neither drug is currently part of the standard treatment of solid tumors in children. Both drugs have been tested alone to treat solid tumors in children with little success. There is now new insight that if given together, perifosine and temsirolimus may work together to stop the growth of solid tumors and may also make them shrink. The doctor wants to find out what effects; good and/or bad, perifosine in combination with temsirolimus has on the patient and the cancer. The doctors are testing four different dose schedules of perifosine with temsirolimus and the patient will be asked to partake in one of the dose schedules. The dose schedule will be lower for those enrolled early in the study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pediatric Solid Tumors
Intervention  ICMJE Drug: perifosine + temsirolimus
The patient will take oral tablets of perifosine at a dose and frequency to be determined their height, weight and time when they enter the study as those entering early will be treated with lower dose levels (dosing frequency will vary from once a week to daily). The patient will receive an intravenous injection of temsirolimus once a week at a dose to be determined by their height, weight and time when they enter the study as those entering early will be treated with lower doses. In addition they will be asked to keep a medicine diary.
Study Arms  ICMJE Experimental: perifosine + temsirolimus
This is a single arm, phase I study. Eligible patients will receive a loading dose of oral perifosine on the first day, followed by a maintenance dose starting on the second day until progression. Each patient is assigned to a group according to their body surface area (BSA). Temsirolimus will be combined with perifosine at four dose levels to determine the MTD for the combination therapy. Temsirolimus dosing will start on the same day as the perifosine load.
Intervention: Drug: perifosine + temsirolimus
Publications * Sun W, Modak S. Emerging treatment options for the treatment of neuroblastoma: potential role of perifosine. Onco Targets Ther. 2012;5:21-9. doi: 10.2147/OTT.S14578. Epub 2012 Mar 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2017)
23
Original Estimated Enrollment  ICMJE
 (submitted: January 14, 2010)
30
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 sampling.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE up to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01049841
Other Study ID Numbers  ICMJE 09-124
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE
  • University of Wisconsin, Madison
  • Duke University
  • NATL COMP CA NETWORK
  • Pfizer
  • AEterna Zentaris
Investigators  ICMJE
Principal Investigator:Ira Dunkel, MDMemorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP