| October 20, 2008 |
| October 2, 2009 |
| October 2008 |
| October 2010 (final data collection date for primary outcome measure) |
| Maximum Tolerated Dose (MTD) of perifosine monotherapy in children with
cancer [ Time Frame: conclusion of the study ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00776867 on ClinicalTrials.gov Archive Site |
- To determine whether pharmacokinetic serum levels correlate with toxicity [ Time Frame: conclusion of the study ] [ Designated as safety issue: Yes ]
- If previously resected tissue is available, determine whether molecular features
predict response including Elevated PI3K/AKT/mTOR signaling, Elevated RAS/MAPK signaling, Cell cycle markers [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Study of Single Agent Perifosine for Recurrent Pediatric Solid Tumors |
| 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. |
| |
| Phase I |
| Interventional |
| Treatment, Open Label, Single Group Assignment, Safety Study |
| Solid Tumors |
| Drug: perifosine |
| Experimental: This will be a dose escalation study to determine the maximum tolerated dose (MTD) of perifosine alone in recurrent/progressive pediatric tumors. A standard 3+3 dose escalation design will be employed with 3-6 patients at each dose level. |
| |
| |
| Recruiting |
| 24 |
| October 2010 |
| October 2010 (final data collection date for primary outcome measure) |
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 ≤ 18 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 ≥ 100K 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-nitrourea chemotherapy
- ≥ 6 weeks since last nitroureas
- ≥ 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 7 days prior to registration. Females must not be breast feeding.
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.
|
| Both |
| up to 18 Years |
| No |
|
|
| United States |
| |
| NCT00776867 |
| Oren Becher, MD, Memorial Sloan-Kettering Cancer Center |
| 08-091 |
| Memorial Sloan-Kettering Cancer Center |
| University of Wisconsin, Madison |
| Principal Investigator: |
Oren Becher, MD |
Memorial Sloan-Kettering Cancer Center |
|
|
| Memorial Sloan-Kettering Cancer Center |
| October 2009 |
