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)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by St. Jude Children's Research Hospital.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
St. Jude Children's Research Hospital
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00996723
First received: October 15, 2009
Last updated: June 28, 2012
Last verified: June 2011
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Diffuse Intrinsic Pontine Glioma |
Drug: vandetanib and dasatinib |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of the Combination of Vandetanib and Dasatinib Administered During and After Radiation Therapy in Children With Diffuse Intrinsic Pontine Glioma |
Resource links provided by NLM:
Further study details as provided by St. Jude Children's Research Hospital:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To determine the toxicities associated with the chronic use of vandetanib and dasatinib [ Time Frame: July 2012 ] [ Designated as safety issue: Yes ]
- To characterize the pharmacokinetics of vandetanib and dasatinib in pediatric research participants [ Time Frame: July 2012 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- To explore the association between plasma angiogenic factors and response to current therapy [ Time Frame: July 2012 ] [ Designated as safety issue: No ]
- To evaluate the pharmacodynamics of dasatinib in target receptors and pathways in peripheral mononuclear cells [ Time Frame: July 2012 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 25 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | April 2013 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1 |
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.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Months to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age must be ≥ 18 months and < 21 years
- Diagnosis of DIPG or high-grade glioma originating from the brainstem.
- Lansky (for research participants ≤ 16 years) or Karnofsky (for research participants > 16 years) performance score ≥ 40 at the time of study enrollment
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
- 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
- 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.
- Female research participants of childbearing age and male research participants of child fathering potential must agree to use safe contraceptive methods
Exclusion Criteria:
- Metastatic disease
- Use of enzyme-inducing anticonvulsants
- Research participants who received any other type of anticancer treatment
- Research participants with uncontrolled infection
- 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
- QTc interval prolongation with other medications that required discontinuation of that medication
- Research participants with any history of cardiac arrhythmias or congenital long QT syndrome
- Use of any concomitant medication that may cause QT interval prolongation and/or induce Torsades de Pointes
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00996723
Locations
| United States, Tennessee | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
| Principal Investigator: | Alberto Broniscer, MD | St. Jude Children's Research Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | St. Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT00996723 History of Changes |
| Other Study ID Numbers: | SJBG09 |
| Study First Received: | October 15, 2009 |
| Last Updated: | June 28, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Glioma Pontine Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Astrocytoma Dasatinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 13, 2013