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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00343694 |
Purpose
RATIONALE: Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib in treating young patients with relapsed or refractory solid tumors or leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: sorafenib tosylate |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Study of the Raf Kinase and Receptor Tyrosine Kinase Inhibitor BAY 43-9006 (Sorafenib, NSC# 724772, IND# 69896) in Children With Refractory Solid Tumors or Refractory Leukemias |
| Estimated Enrollment: | 63 |
| Study Start Date: | May 2006 |
| Estimated Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to diagnosis (malignant solid tumor vs leukemia).
Cohorts of 3-6 patients receive escalating doses of sorafenib 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 (DLT). Once the MTD is determined, up to 6 additional patients under 12 years of age may be treated at the MTD. The MTD dose level is also expanded to enroll up to 6 patients with refractory leukemia.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 63 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:
Diagnosis of 1 of the following:
Histologically confirmed malignant solid tumor at original diagnosis or relapse
Histologically confirmed leukemia, including 1 of the following:
Acute lymphoblastic leukemia (ALL)
Acute myeloid leukemia (AML)
Juvenile myelomonocytic leukemia (JMML) meeting the following criteria:
Has ≥ 2 of the following additional diagnostic criteria:
Chronic myelogenous leukemia (CML) in blast crisis
Relapsed or refractory disease
PATIENT CHARACTERISTICS:
Patients with solid tumors must have adequate bone marrow function, as defined by the following:
Patients with leukemia may have abnormal blood counts but must meet the following criteria:
Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine normal based on age as follows:
Patients with solid tumors must meet the following criteria:
Patients with leukemia must meet the following criteria:
PRIOR CONCURRENT THERAPY:
At least 3 months since prior stem cell transplantation or rescue (for patients with solid tumors)
No concurrent administration of any of the following:
No concurrent therapeutic anticoagulation
Contacts and Locations
Show 23 Study Locations| Study Chair: | Brigitte C. Widemann, MD | NCI - Pediatric Oncology Branch |
| Investigator: | Elizabeth Fox, MD | NCI - Pediatric Oncology Branch |
More Information
| Study ID Numbers: | CDR0000483040, COG-ADVL0413, NCI-06-C-0233 |
| Study First Received: | June 22, 2006 |
| Last Updated: | November 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00343694 History of Changes |
| Health Authority: | Unspecified |
|
unspecified childhood solid tumor, protocol specific recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia childhood acute promyelocytic leukemia (M3) Philadelphia chromosome negative chronic myelogenous leukemia |
Philadelphia chromosome positive chronic myelogenous leukemia blastic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia childhood chronic myelogenous leukemia juvenile myelomonocytic leukemia |
|
Leukemia Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Sorafenib Pharmacologic Actions |