Perifosine With Temsirolimus for Recurrent Pediatric Solid Tumors
NCT01049841
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- 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
- 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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| 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 | 23 | |||
| Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
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| Investigators ICMJE |
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| 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 | ||||