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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| 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 Genetic: gene expression analysis Genetic: proteomic profiling Other: laboratory biomarker analysis Other: pharmacological study |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Study of the Raf Kinase and Receptor Tyrosine Kinase Inhibitor Sorafenib (BAY 43-9006, NSC# 724772, IND# 69896) in Children With Refractory Solid Tumors or Refractory Leukemias |
| Estimated Enrollment: | 77 |
| Study Start Date: | May 2006 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Show Detailed Description
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)
AML and FLT3-ITD mutation
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:
Patients with acute myeloid leukemia and FLT3-ITD mutation
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)
At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) (for patients with solid tumors)
No other concurrent anticancer agents or therapies, including chemotherapy, radiotherapy, immunotherapy, or biologic therapy
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
| ClinicalTrials.gov Identifier: | NCT00343694 History of Changes |
| Other Study ID Numbers: | CDR0000483040, COG-ADVL0413, NCI-06-C-0233 |
| Study First Received: | June 22, 2006 |
| Last Updated: | August 31, 2011 |
| 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 |
chronic myelogenous leukemia, BCR-ABL1 positive blastic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia childhood chronic myelogenous leukemia juvenile myelomonocytic leukemia |
|
Leukemia Neoplasms Neoplasms by Histologic Type Sorafenib Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |