|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Pediatric Brain Tumor Consortium |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | Pediatric Brain Tumor Consortium |
| ClinicalTrials.gov Identifier: | NCT00572182 |
Purpose
RATIONALE: MK0752 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of MK0752 in treating young patients with recurrent or refractory CNS cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: MK-0752 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of MK-0752 in Pediatric Patients With Recurrent or Refractory CNS Malignancies |
| Enrollment: | 33 |
| Study Start Date: | July 2008 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive oral MK0752 once daily on days 1-3, 8-10, 15-17, and 22-24 (dosing regimen 1 - closed to accrual 2/23/2010) or days 1, 8, 15, and 22 (dosing regimen 2). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Treatment may be extended up to 19 courses if the patient is benefitting from the treatment.
Patients undergo blood sample collection periodically for pharmacokinetic studies.
After completion of study treatment, patients are followed for 30 days.
Eligibility| Ages Eligible for Study: | 3 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary CNS tumor
PATIENT CHARACTERISTICS:
Creatinine clearance OR glomerular filtration rate ≥ 70 mL/min OR serum creatinine based on age as follows:
PRIOR CONCURRENT THERAPY:
At least 7 days since prior investigational or biologic agents
At least 6 months since prior allogeneic bone marrow transplantation (BMT)
Contacts and Locations| United States, California | |
| UCSF Helen Diller Family Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010-2970 | |
| United States, Illinois | |
| Children's Memorial Hospital - Chicago | |
| Chicago, Illinois, United States, 60614 | |
| United States, Maryland | |
| NCI - Pediatric Oncology Branch | |
| Bethesda, Maryland, United States, 20892 | |
| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229-3039 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104-4318 | |
| Children's Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Tennessee | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
| United States, Texas | |
| Dan L. Duncan Cancer Center at Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Seattle Children's Hospital | |
| Seattle, Washington, United States, 98105 | |
| Study Chair: | Maryam Fouladi, MD | Children's Hospital Medical Center, Cincinnati |
More Information
| Responsible Party: | Pediatric Brain Tumor Consortium |
| ClinicalTrials.gov Identifier: | NCT00572182 History of Changes |
| Obsolete Identifiers: | NCT00923208 |
| Other Study ID Numbers: | CDR0000578114, U01CA081457, PBTC-024, NCI-09-C-0112 |
| Study First Received: | December 11, 2007 |
| Last Updated: | March 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent childhood brain stem glioma childhood central nervous system germ cell tumor recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma childhood high-grade cerebral astrocytoma childhood choroid plexus tumor childhood craniopharyngioma recurrent childhood ependymoma recurrent childhood medulloblastoma |
childhood oligodendroglioma recurrent childhood pineoblastoma recurrent childhood supratentorial primitive neuroectodermal tumor childhood atypical teratoid/rhabdoid tumor childhood spinal cord neoplasm childhood infratentorial ependymoma childhood supratentorial ependymoma recurrent childhood visual pathway and hypothalamic glioma childhood grade III meningioma |
|
Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms by Site Neoplasms Nervous System Diseases |