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Trial record 11 of 68 for:    DIPG

Clinical Trial Evaluating the Combination of Vandetanib and Dasatinib During and After Radiation Therapy (RT) in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)

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ClinicalTrials.gov Identifier: NCT00996723
Recruitment Status : Completed
First Posted : October 16, 2009
Last Update Posted : April 6, 2015
Sponsor:
Collaborators:
AstraZeneca
The Cure Starts Now Foundation
Tyler's Treehouse
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

October 15, 2009
October 16, 2009
April 6, 2015
October 2009
April 2012   (Final data collection date for primary outcome measure)
To estimate the maximum tolerated dose (MTD) of the combination of vandetanib and dasatinib administered concurrently with RT in pediatric research participants with newly diagnosed DIPG [ Time Frame: April 2012 ]
To estimate the maximum tolerated dose (MTD) of the combination of vandetanib and dasatinib administered concurrently with RT in pediatric research participants with newly diagnosed DIPG [ Time Frame: July 2012 ]
Complete list of historical versions of study NCT00996723 on ClinicalTrials.gov Archive Site
  • To determine the toxicities associated with the chronic use of vandetanib and dasatinib [ Time Frame: July 2012 ]
  • To characterize the pharmacokinetics of vandetanib and dasatinib in pediatric research participants [ Time Frame: July 2012 ]
  • To evaluate the influence of specific polymorphisms (e.g., CYP3A4/5) on the pharmacokinetics of vandetanib and dasatinib administered in combination [ Time Frame: July 2012 ]
  • To explore the association between plasma angiogenic factors and response to current therapy [ Time Frame: July 2012 ]
  • To evaluate the pharmacodynamics of dasatinib in target receptors and pathways in peripheral mononuclear cells [ Time Frame: July 2012 ]
  • To describe the research participants' and parents' perspective of the quality of life of children with newly diagnosed DIPG enrolled on this phase I trial [ Time Frame: July 2012 ]
  • To describe the quality of life of parents of pediatric research participants with newly diagnosed DIPG enrolled on this phase I trial [ Time Frame: July 2012 ]
Same as current
Not Provided
Not Provided
 
Clinical Trial Evaluating the Combination of Vandetanib and Dasatinib During and After Radiation Therapy (RT) in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)
Phase I Study of the Combination of Vandetanib and Dasatinib Administered During and After Radiation Therapy in Children With Diffuse Intrinsic Pontine Glioma
This is a Phase I clinical trial evaluating the combination of vandetanib and dasatinib during and after radiation therapy (RT) in children with newly diagnosed diffuse intrinsic pontine glioma (DIPG).
This trial will estimate the maximum safe dose of vandetanib and dasatinib which can be administered during the 6 weeks of local RT in children with newly diagnosed DIPG.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diffuse Intrinsic Pontine Glioma
Drug: vandetanib and dasatinib
Two oral investigational agents (vandetanib [VEGFR2, RET, and EGFR inhibitor] and dasatinib [bcr-abl, PDGFRA and B, src, lck, yes, and c-kit inhibitor] will be administered during and after local RT, which is the only standard therapy for children with DIPG.
1
Intervention: Drug: vandetanib and dasatinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
28
June 2014
April 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age must be ≥ 18 months and < 21 years
  2. Diagnosis of DIPG or high-grade glioma originating from the brainstem.
  3. Lansky (for research participants ≤ 16 years) or Karnofsky (for research participants > 16 years) performance score ≥ 40 at the time of study enrollment
  4. Adequate organ function at the time of study enrollment as follows:

    • Bone marrow: ANC ≥ 1,000/μL, platelet count ≥ 100,000/μL (transfusion independent), hemoglobin concentration ≥ 8g/dL (may be transfused)
    • Renal: Serum creatinine concentration < 2x the institutional normal values for age or GFR > 70ml/min/1.73m2
    • Hepatic: Total bilirubin concentration < 1.5x the institutional upper limit of normal for age; SGPT < 5x the institutional upper limit of normal; albumin ≥ 2 g/dL
  5. Electrocardiogram (EKG) with an average QTc interval < 450 msec. If a research participant has QTc interval ≥ 450 msec on screening EKG, the screening EKG may be repeated twice (at least 24 hours apart). The average QTc interval from the three screening EKGs must be < 450 msec in order for the research participant to be eligible for the study. Research participants with abnormal serum electrolytes and a QTc interval ≥ 450 msec should have a repeat EKG repeated once the concentration of serum electrolyte is corrected
  6. Female research participants of childbearing age must not be pregnant (confirmed by serum or urine pregnancy test within 1 week of treatment start) or breast-feeding.
  7. Female research participants of childbearing age and male research participants of child fathering potential must agree to use safe contraceptive methods

Exclusion Criteria:

  1. Metastatic disease
  2. Use of enzyme-inducing anticonvulsants
  3. Research participants who received any other type of anticancer treatment
  4. Research participants with uncontrolled infection
  5. Research participants with any concomitant significant medical illness that in the investigator's opinion cannot be adequately controlled with appropriate therapy, or that would impair the evaluation of side effects related to this treatment, alter drug metabolism or the tolerance to this treatment
  6. QTc interval prolongation with other medications that required discontinuation of that medication
  7. Research participants with any history of cardiac arrhythmias or congenital long QT syndrome
  8. Use of any concomitant medication that may cause QT interval prolongation and/or induce Torsades de Pointes
  9. Hypertension defined as systolic and/or diastolic blood pressure > 95th percentile for age, height and gender, or blood pressure > 140/90 for research participants ≥ 18 years of age. If hypertension is detected, blood pressure values < 95th in two separate occasions need to be documented before registration. Body surface ≥ 1.8m2 for research participants enrolled on dosage levels 2, 3, and 4
Sexes Eligible for Study: All
18 Months to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00996723
SJBG09
NCI-2011-01152 ( Registry Identifier: NCI Clinical Trial Registration Program )
Yes
Not Provided
Not Provided
St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
  • AstraZeneca
  • The Cure Starts Now Foundation
  • Tyler's Treehouse
Principal Investigator: Alberto Broniscer, MD St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP