A Phase I/II Study of Ribociclib,a CDK4/6 Inhibitor, Following Radiation Therapy

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT02607124
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Bithalamic High Grade Glioma
  • Diffuse Intrinsic Pontine Glioma
  • High Grade Glioma

Eligibility Criteria

Sex
ALL
Age
12 Months - 30 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

In this research study the investigators want to learn more about the effects, both good and bad, when the study drug Ribociclib is given after radiation therapy. The investigators are asking people to be in this research study that have been newly diagnosed with a high grade glioma, and the tumor has been screened for the Rb1 protein, and have recently finished radiation therapy. Patients with a DIPG or a Bi-thalamic high grade glioma do not need to have tumor tissue screened for the Rb1 protein but do need to have finished radiation therapy. Tumor cells grow and divide quickly. In normal cells, there are proteins called cyclin-dependent kinases (CDK 4 and 6) that control cell division. Another protein Rb1 also controls cell division and works to stop cells from dividing so they do not become cancer cells. But in cancer, the CDK 4 and 6 proteins are out of control making the cells divide and grow quickly. The study drug, ribociclib stops the CDK 4 and 6 proteins. When the CDK 4 and 6 proteins are stopped, the normal Rb1 protein can now work to slow cell growth. For patients with HGG, to be in this study tumor tissue must have a normal Rb1 protein. The researchers think that if the study drug is given soon after radiation therapy, it may help improve the effect of the radiation in stopping the tumor from growing. The study drug, Ribociclib is considered investigational as it has not yet been approved by the United States Food and Drug Administration. The study drug has been tested in children and adults with cancer in prior research studies.

Key Dates

Start date
Apr 30, 2016
Status verified
Oct 2020
Primary completion
May 31, 2018
Completion
Aug 31, 2018

Study Design

Enrollment
11 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RB+ High Grade Glioma
    Ribociclib administered orally; daily on days 1-21 each 28 day cycle; dose calculation age dependent (\>21 yrs of age 600mg daily (DIPG); \<21 yrs of age 350 mg/m2/day)
  • Experimental: Non-Biopsied Diffuse Instrinsic Pontine Glioma
    Ribociclib administered orally; daily on days 1-21 each 28 day cycle; dose calculation age dependent (\>21 yrs of age 600mg daily (DIPG); \<21 yrs of age 350 mg/m2/day)

Primary Outcome Measure

Number of Adverse Events [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-

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Cincinnati Children's Hospital Medical Center· Cincinnati, OH

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