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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00996723
Other study ID # SJBG09
Secondary ID NCI-2011-01152
Status Completed
Phase Phase 1
First received October 15, 2009
Last updated April 3, 2015
Start date October 2009
Est. completion date June 2014

Study information

Verified date April 2015
Source St. Jude Children's Research Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date June 2014
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Months to 21 Years
Eligibility 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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States St. Jude Children's Research Hospital Memphis Tennessee

Sponsors (4)

Lead Sponsor Collaborator
St. Jude Children's Research Hospital AstraZeneca, The Cure Starts Now Foundation, Tyler's Treehouse

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 April 2012 Yes
Secondary To determine the toxicities associated with the chronic use of vandetanib and dasatinib July 2012 Yes
Secondary To characterize the pharmacokinetics of vandetanib and dasatinib in pediatric research participants July 2012 No
Secondary To evaluate the influence of specific polymorphisms (e.g., CYP3A4/5) on the pharmacokinetics of vandetanib and dasatinib administered in combination July 2012 No
Secondary To explore the association between plasma angiogenic factors and response to current therapy July 2012 No
Secondary To evaluate the pharmacodynamics of dasatinib in target receptors and pathways in peripheral mononuclear cells July 2012 No
Secondary 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 July 2012 No
Secondary To describe the quality of life of parents of pediatric research participants with newly diagnosed DIPG enrolled on this phase I trial July 2012 No
See also
  Status Clinical Trial Phase
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Recruiting NCT05476939 - Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0 Phase 3
Terminated NCT03330197 - A Study of Ad-RTS-hIL-12 + Veledimex in Pediatric Subjects With Brain Tumors Including DIPG Phase 1/Phase 2
Terminated NCT03690869 - REGN2810 in Pediatric Patients With Relapsed, Refractory Solid, or Central Nervous System (CNS) Tumors and Safety and Efficacy of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed or Recurrent Glioma Phase 1/Phase 2
Active, not recruiting NCT02992015 - Gemcitabine in Newly-Diagnosed Diffuse Intrinsic Pontine Glioma Early Phase 1
Terminated NCT01182350 - Molecularly Determined Treatment of Diffuse Intrinsic Pontine Gliomas (DIPG) Phase 2
Recruiting NCT04837547 - PEACH TRIAL- Precision Medicine and Adoptive Cellular Therapy Phase 1
Active, not recruiting NCT04911621 - Adjuvant Dendritic Cell Immunotherapy for Pediatric Patients With High-grade Glioma or Diffuse Intrinsic Pontine Glioma Phase 1/Phase 2
Not yet recruiting NCT06333899 - Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion Early Phase 1
Completed NCT00879437 - Valproic Acid, Radiation, and Bevacizumab in Children With High Grade Gliomas or Diffuse Intrinsic Pontine Glioma Phase 2
Active, not recruiting NCT02420613 - Vorinostat and Temsirolimus With or Without Radiation Therapy in Treating Younger Patients With Newly Diagnosed or Progressive Diffuse Intrinsic Pontine Glioma Phase 1
Completed NCT03086616 - CED With Irinotecan Liposome Injection Using Real Time Imaging in Children With Diffuse Intrinsic Pontine Glioma (DIPG) (PNOC 009) Phase 1
Recruiting NCT01837862 - A Phase I Study of Mebendazole for the Treatment of Pediatric Gliomas Phase 1/Phase 2
Not yet recruiting NCT06093165 - RE-irradiation of Diffuse MIdline Glioma paTients N/A
Withdrawn NCT03632317 - A Study of Panobinostat in Combination With Everolimus for Children and Young Adults With Gliomas Phase 2
Completed NCT02502708 - Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors Phase 1
Recruiting NCT02233049 - Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication Phase 2
Recruiting NCT05009992 - Combination Therapy for the Treatment of Diffuse Midline Gliomas Phase 2
Recruiting NCT04049669 - Pediatric Trial of Indoximod With Chemotherapy and Radiation for Relapsed Brain Tumors or Newly Diagnosed DIPG Phase 2
Recruiting NCT05298995 - GD2-CAR T Cells for Pediatric Brain Tumours Phase 1