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NCT01239316 · ClinicalTrials.gov registry record · Phase 2
Vismodegib in Treating Younger Patients With Recurrent or Refractory Medulloblastoma
A Phase 2 study of Recurrent Childhood Medulloblastoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 12
- Study locations
NCT01239316: Completed Phase 2 study of Recurrent Childhood Medulloblastoma, sponsored by National Cancer Institute (NCI).
NCT01239316 is a Phase 2 study of Recurrent Childhood Medulloblastoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 12 participants, below the 54-participant average among 3 other Recurrent Childhood Medulloblastoma trials with a reported enrollment target (78% lower). The trial reports 12 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01239316, a Phase 2 study of Recurrent Childhood Medulloblastoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 12
- Study locations
Study Summary
This phase II trial studies how well vismodegib works in treating younger patients with recurrent or refractory medulloblastoma. Vismodegib may slow the growth of tumor cells.
Primary Outcome
Objective response is either a complete response or a partial response sustained for 8 weeks in a patient. The objective response rate will be reported separately for patients of each stratum. CR is complete disappearance of all enhancing tumor. PR is \>= 50% reduction in tumor size.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Vismodegib
- OTHER Pharmacological Study
Study Locations (12)
California
- Children's Hospital Los Angeles - Los Angeles
- Lucile Packard Children's Hospital Stanford University - Palo Alto
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- Children's Hospital of Pittsburgh of UPMC - Pittsburgh
District of Columbia
- Children's National Medical Center - Washington D.C.
Illinois
- Lurie Children's Hospital-Chicago - Chicago
Maryland
- National Cancer Institute Pediatric Oncology Branch - Bethesda
New York
- Memorial Sloan-Kettering Cancer Center - New York
North Carolina
- Duke University Medical Center - Durham
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2010-11 |
| Est. Completion | 2015-08 |
| Phase | Phase 2 |
What the finished NCT01239316 record still lists
NCT01239316 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 54-participant average among 3 other Recurrent Childhood Medulloblastoma trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Recurrent Childhood Medulloblastoma appearing as the primary indexed condition, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01239316 lists 12 locations in 10 states (California, Pennsylvania, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT01239316 about?
NCT01239316 is a clinical study titled "Vismodegib in Treating Younger Patients With Recurrent or Refractory Medulloblastoma". This phase II trial studies how well vismodegib works in treating younger patients with recurrent or refractory medulloblastoma. Vismodegib may slow the growth of tumor cells.
What is the current status of trial NCT01239316?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2010-11. Estimated completion is 2015-08.
What conditions does trial NCT01239316 study?
This clinical trial studies the following conditions: Recurrent Childhood Medulloblastoma.
What interventions are being tested in trial NCT01239316?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Vismodegib (DRUG), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT01239316?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01239316 being conducted?
This trial has 12 study locations across California, District of Columbia, Illinois, Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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