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NCT01222754 · ClinicalTrials.gov registry record · Phase 1
Lenalidomide and Radiation Therapy in High Grade Gliomas or Diffuse Intrinsic Pontine Gliomas
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT01222754: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01222754 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 29 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01222754, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
Background: \- Children who are diagnosed with brain tumors known as high grade gliomas or diffuse intrinsic pontine gliomas are generally treated with radiation therapy and chemotherapy. However, these tumors are very difficult to cure, and the tumor frequently begins to grow again even after treatment or surgery. Researchers are interested in determining whether the anticancer drug lenalidomide, which has been used to treat other aggressive types of cancer, is a safe and effective additional treatment for children who are scheduled to receive radiation therapy to treat high grade gliomas or diffuse intrinsic pontine gliomas. Objectives: \- To determine the safety and effectiveness of lenalidomide, in conjunction with radiation therapy, as a treatment for children who have been diagnosed with high grade gliomas or diffuse intrinsic pontine gliomas. Eligibility: \- Children and adolescents up to 21 years of age who have been diagnosed with high grade gliomas or diffuse intrinsic pontine gliomas and have not had radiotherapy or chemotherapy. Design: * Participants will be screened with a medical history, physical examination, blood and urine tests, and imaging studies. * Participants will have two phases of treatment: a lenalidomide plus radiation phase and a lenalidomide-only phase. * During the radiation phase, participants will take lenalidomide daily and have 6 weeks of radiation therapy (five treatments per week). After the radiation therapy, participants will stop taking lenalidomide for 2 weeks before continuing to the next phase. * During the lenalidomide-only phase, participants will take lenalidomide daily for 21 days, followed by 7 days without lenalidomide (28-day cycle of treatment). Participants will have up to 24 cycles of lenalidomide. * Participants will have frequent blood tests during the first cycle of treatment, and will have imaging studies or other tests as required by the study researchers. * Treatment will continue until the disease pr
Interventions
- DRUG Lenalidomide
- RADIATION XRT, 54-59.4 Gy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2010-11-23 |
| Est. Completion | 2019-04-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01222754
The ClinicalTrials.gov registry entry for NCT01222754 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lenalidomide is the first listed.
NCT01222754 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01222754 about?
NCT01222754 is a clinical study titled "Lenalidomide and Radiation Therapy in High Grade Gliomas or Diffuse Intrinsic Pontine Gliomas". Background: \- Children who are diagnosed with brain tumors known as high grade gliomas or diffuse intrinsic pontine gliomas are generally treated with radiation therapy and chemotherapy. However, these tumors are very difficult to cure, and the tumor frequently begins to grow again even after trea...
What is the current status of trial NCT01222754?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2010-11-23. Estimated completion is 2019-04-17.
What interventions are being tested in trial NCT01222754?
The interventions under investigation include: Lenalidomide (DRUG), XRT, 54-59.4 Gy (RADIATION).
Who is sponsoring clinical trial NCT01222754?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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