Clinical Trial Finder

Abemaciclib in Children With DIPG or Recurrent/Refractory Solid Tumors

Study Purpose

This is a Phase I clinical trial evaluating abemaciclib (LY2835219), an inhibitor of cyclin dependent-kinases 4 and 6 (Cdk 4/6) in children and young adults with newly diagnosed diffuse intrinsic pontine glioma (DIPG) (Stratum A) and in relapsed/refractory/progressive malignant brain (Grade III/IV, including DIPG; MBT) and solid tumor (ST) patients (Stratum B).

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Study Type
Interventional
Eligible Ages 2 Years - 25 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Inclusion Criteria - All Participants: 1.
Age must be ≥ 2 and < 21 years 2. BSA ≥ 0.5 m2 3. Must have measurable or evaluable disease 4. Diagnosis of DIPG (Stratum A), or recurrent/refractory/progressive MBT (WHO Grade III/IV) or ST, including neuroblastoma, Ewing sarcoma, rhabdomyosarcoma, malignant rhabdoid tumor and osteosarcoma (Stratum B). 5. Lansky (for participants ≤ 16 years) or Karnofsky (for participants > 16 years) performance score ≥ 40 at the time of study enrollment 6. Adequate organ function at the time of study enrollment as follows: 7. Bone marrow: ANC ≥ 1,000/μL, platelet count ≥ 75,000/μL (transfusion independent meaning not having had platelet transfusion for 7 days prior to enrollment), hemoglobin concentration ≥ 8g/dL (may be transfused). Participants with bone marrow involvement are eligible but not evaluable for hematologic toxicity. 8. Renal: Normal serum creatinine concentration 9. Hepatic: Total bilirubin concentration < 1.5x the institutional upper limit of normal for age; SGPT < 3x the institutional upper limit of normal 10. Female research participants of childbearing potential (age 10 or greater) must not be pregnant as confirmed by a serum or urine pregnancy test and confirmed within 1 week of start of treatment. Participants must not be breast-feeding. 11. Males or females of reproductive potential may not participate unless they have agreed to use two effective contraceptive methods. Abstinence in a non-sexually active child will be sufficient birth control. Inclusion Criteria
  • - Stratum A - Newly Diagnosed DIPG 1.
Diagnosis of DIPG or high-grade glioma originating from the brainstem 2. Participants have had no previous treatment except corticosteroid use. 3. Participants are able to take abemaciclib as intact capsules by mouth. Inclusion Criteria
  • - Stratum B - Recurrent/refractory/progressive MBT (including DIPG) or ST 1.
Participants must have radiologic evidence of recurrent, refractory or progressive malignant brain tumor or solid tumor 2. Participants must be able to swallow capsules. 3. Participants with neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration. 4. Participants who are on dexamethasone must be on a stable or decreasing dose for at least one week prior to registration. 5. Participants must have fully recovered from the acute toxic effects of chemotherapy, immunotherapy, or radiotherapy prior to entering this study. 6. Myelosuppressive chemotherapy: Participants must have received their last dose of known myelosuppressive anticancer chemotherapy at least 21 days prior to study registration or at least six weeks if nitrosourea. At least two weeks must have lapsed if participants received lower dose oral etoposide (50 mg/m2) without experiencing evidence of myelosuppression (i.e. neutropenia or requiring transfusion with blood products) 7. Biologic agent: Participants must have recovered from any toxicity potentially related to the agent and received their last dose of the biologic agent ≥ 7 days prior to study registration. 8. Monoclonal antibody treatment: At least three half-lives must have elapsed prior to registration. 9. Radiation: Participant has received radiation therapy prior to study registration. Participants must have had their last fraction of local irradiation to the primary tumor ≥ 3 months prior to registration, their last fraction of craniospinal irradiation (>24Gy) or total body irradiation > 3 months prior to registration. Participant has not received focal irradiation for symptomatic metastatic sites within 14 days prior to registration. 10. Bone Marrow Transplant: Participant must be ≥ 3 months since high dose chemotherapy and peripheral blood stem cell rescue prior to registration. 11. Growth factors: Participants must be off all colony forming growth factors(s) for at least 1 week prior to registration (filgrastim, sargramostim, erythropoietin) and at least 2 weeks for long-acting formulations (e.g. neupogen).

Exclusion Criteria:

1. Uncontrolled infection 2. Prior history of QTc prolongation or QTcF > 450 ms on screening ECG. 3. Any concomitant significant medical illness that 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 4. Receiving any other anticancer or investigational drug therapy 5. Prior therapy with abemaciclib

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT02644460

Phase 0: Exploratory study involving very limited human exposure to the drug to determine whether a drug is modulating its target.

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 1

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Emory University

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Diffuse Intrinsic Pontine Glioma, Brain Tumor, Recurrent, Solid Tumor, Recurrent, Neuroblastoma, Recurrent, Refractory, Ewing Sarcoma, Recurrent, Refractory, Rhabdomyosarcoma, Recurrent, Refractory, Osteosarcoma, Recurrent, Refractory, Rhabdoid Tumor, Recurrent, Refractory
Additional Details

Stratum A- Appropriate dose RT will be administered in 30-33 fractions over approximately 6 weeks for Stratum A patients. Treatment with abemaciclib (LY2835219) will start on the same day as RT and continue twice daily during and after RT for a maximum treatment duration of 2 years. Investigators plan to treat a maximum of 4 cohorts of research participants (dosage levels 1, 2, 3, and 4) with escalating doses of abemaciclib (LY2835219) starting with dose level 1 (80% of adult dose). A cycle is defined as 28 days and the first 6 weeks of therapy will constitute the dose-limiting toxicity (DLT)-evaluation period. Participants must take abemaciclib by mouth as intact capsules. Stratum B

  • - Abemaciclib (LY2835219) will be administered orally on a twice daily basis continuously for 28 days, which defines one cycle.
The maximum treatment duration will be 2 years. Investigators plan to treat a maximum of 4 cohorts of research participants (dosage levels 1, 2, 3, and 4) with escalating doses of abemaciclib starting with dose level 1 (80% of adult dose). Dose escalation will be independent of Stratum A escalation. A cycle is defined as 28 days and the first 4 weeks of therapy will constitute the DLT-evaluation period. Participants must take abemaciclib by mouth as intact capsules.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Hospital colorado, Aurora, Colorado

Status

Recruiting

Address

Children's Hospital colorado

Aurora, Colorado, 80045

Site Contact

Astrid Eder, PhD, CCRP

astrid.eder@childrenscolorado.org

720-777-8531

Atlanta, Georgia

Status

Recruiting

Address

Children's Healthcare of Atlanta, Egleston

Atlanta, Georgia, 30322

Site Contact

Amy Autry-Bush

amy.autry-bush@choa.org

404-785-6011

Atlanta, Georgia

Status

Recruiting

Address

Children's Healthcare of Atlanta, Scottish Rite

Atlanta, Georgia, 30342

Site Contact

Amy Autry-Bush

amy.autry-bush@choa.org

404-785-6011

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