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Sorafenib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia

NCT01445080 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-02-02

Study results available
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Summary

This phase I/II trial is studying the side effects and best dose of sorafenib in treating young patients with relapsed or refractory solid tumors or leukemia. 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.

Conditions

  • Blastic Phase
  • Childhood Acute Promyelocytic Leukemia With PML-RARA
  • Childhood Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Childhood Solid Neoplasm
  • Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Juvenile Myelomonocytic Leukemia
  • Philadelphia Chromosome Negative, BCR-ABL1 Positive Chronic Myelogenous Leukemia
  • Recurrent Childhood Acute Lymphoblastic Leukemia
  • Recurrent Childhood Acute Myeloid Leukemia
  • Recurrent Disease

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Pharmacological Study

Correlative studies

DRUG

Sorafenib Tosylate

Given orally

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Brigitte C Widemann · COG Phase I Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-30
Primary Completion
2012-03-16
Completion
2012-12-10

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01445080 on ClinicalTrials.gov