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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00387920 |
Purpose
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth and by blocking blood flow to the tumor.
PURPOSE: This phase I trial is studying the side effects and best dose of sunitinib in treating young patients with refractory solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: sunitinib malate Other: mass spectrometry Other: pharmacological study |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Study of Sunitinib (SU11248), an Oral Multi-Targeted Tyrosine Kinase Inhibitor, in Children With Refractory Solid Tumors |
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2006 |
| Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study (part A) followed by a pediatric-friendly formulation study (part B).
Patients receive oral sunitinib malate once daily on days 1-28 days. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of sunitinib malate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients receive sunitinib malate capsule contents sprinkled over applesauce or yogurt once daily on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. After the first course, patients may switch to capsule formulation for convenience.
NOTE: Patients will not receive sunitinib malate on day 2 of the first course to allow for pharmacokinetic testing.
Blood is collected on days 1, 7, 14, 21, and 28 of course 1 for pharmacokinetic studies using liquid chromatography/mass spectrometry.
After completion of study treatment, patients are followed up for 30 days.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 2 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor (not required for patients with intrinsic brain stem tumors or optic pathway gliomas)
Patients with metastatic bone marrow disease are eligible but are not evaluable for hematologic toxicity
Primary CNS tumors or known CNS metastases allowed
PATIENT CHARACTERISTICS:
Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine based on age/gender as follows:
PRIOR CONCURRENT THERAPY:
At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the following:
At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:
No concurrent antithrombotic or antiplatelet agents, including any of the following:
Contacts and Locations
Show 20 Study Locations| Study Chair: | Steven DuBois, MD | UCSF Medical Center at Parnassus |
More Information
| Study ID Numbers: | CDR0000507414, COG-ADVL0612, NCI-07-C-0220 |
| Study First Received: | October 12, 2006 |
| Last Updated: | January 19, 2010 |
| ClinicalTrials.gov Identifier: | NCT00387920 History of Changes |
| Health Authority: | Unspecified |
|
unspecified childhood solid tumor, protocol specific |
|
Neoplasms Antineoplastic Agents Sunitinib Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |