MK0752 in Treating Young Patients With Recurrent or Refractory CNS Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Maximum tolerated dose [ Time Frame: First 28 days of treatment ] [ Designated as safety issue: Yes ]
- MK0752 systemic exposure [ Time Frame: Day 1 of course 1 ] [ Designated as safety issue: No ]Serial blood samples for pharmacokinetic studies of MK-0752 will be collected with the first dose of course 1 at pre-specified times.
- Pharmacokinetics [ Time Frame: Day 1 of course 1 ] [ Designated as safety issue: No ]Serial blood samples for pharmacokinetic studies of MK-0752 will be collected with the first dose of course 1 at pre-specified times.
- Toxicity [ Time Frame: From day 1 of treatment until off study ] [ Designated as safety issue: Yes ]
- Objective response rate [ Time Frame: End of courses 2, 4, 6 and at the end of treatment ] [ Designated as safety issue: No ]Brain imaging to assess tumor response to the treatment is performed at baseline, at the end of courses 2, 4, 6 and at the end of therapy.
| 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) |
-
Drug: MK-0752
OBJECTIVES:
Primary
- To estimate the maximum tolerated dose (MTD) and recommended phase II dose of MK0752 administered for 3 consecutive days of every 7 days in 28 day courses to young patients with recurrent or refractory CNS malignancies (Dosing regimen 1 - closed to accrual 2/23/2010).
- To estimate the MTD and recommend a phase II dose of MK0752 administered once weekly in 28 day courses to young patients with recurrent or refractory CNS malignancies (Dosing regimen 2).
- To compared the MK0752 systemic exposure attained with each dosage level on the different dosing regimens.
Secondary
- To characterize the pharmacokinetics of MK0752.
- To document and describe toxicities associated with MK0752.
- To preliminarily define the antitumor activity of MK0752 within the confines of a phase I setting.
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
- Patients with intrinsic brain stem tumors do not require histologic verification, but must have radiographic evidence of progression
- Recurrent disease or refractory to standard therapy
- No histologically benign brain tumors (e.g., low-grade glioma)
PATIENT CHARACTERISTICS:
- Karnofsky performance status (PS) or Lansky PS 60-100%
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Absolute neutrophil count ≥ 1,000/μL
- Platelet count ≥ 100,000/μL (unsupported)
- Hemoglobin ≥ 8 g/dL (RBC transfusions allowed)
Creatinine clearance OR glomerular filtration rate ≥ 70 mL/min OR serum creatinine based on age as follows:
- 0.8 mg/dL (≤ 5 years of age)
- 1.0 mg/dL (> 5 to ≤ 10 years of age)
- 1.2 mg/dL (> 10 to ≤ 15 years of age)
- 1.5 mg/dL (> 15 years of age)
- Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
- ALT ≤ 2.5 times ULN for age
- Albumin ≥ 2.5 g/dL
- Sodium, potassium, magnesium, and calcium normal
- Patients with neurological deficits are eligible provided these deficits are stable for ≥ 2 weeks prior to study registration
- No clinically significant systemic illness (e.g., serious infection or significant cardiac, pulmonary, hepatic, or other organ dysfunction) that would compromise the patient's ability to tolerate study therapy or would likely interfere with the study procedures or results
- No known hypersensitivity to MK0752
PRIOR CONCURRENT THERAPY:
- Recovered from the acute toxic effects of all prior therapy
- At least 3 weeks since prior myelosuppressive anticancer chemotherapy (6 weeks for nitrosoureas)
At least 7 days since prior investigational or biologic agents
- At least 3 weeks since prior investigational or biologic agents that have a prolonged half-life or for which the patient has experienced ≥ grade 2 myelosuppression in the treatment course preceding discontinuation of therapy
- At least 3 half lives since prior monoclonal antibody therapy
- At least 6 months since prior total body irradiation or craniospinal radiotherapy
- At least 6 weeks since other prior substantial bone marrow irradiation
- At least 2 weeks since prior local palliative radiotherapy (small volume)
At least 6 months since prior allogeneic bone marrow transplantation (BMT)
- No evidence of active graft versus host disease
- At least 3 months since prior autologous BMT or stem cell transplantation
- At least 7 days since prior hematopoietic growth factors (filgrastim [G-CSF], sargramostim [GM-CSF], or erythropoietin) (14 days for long-acting formulations)
- No prior MK0752
- No concurrent enzyme-inducing anticonvulsant drugs (EIACDs)
- No other concurrent anticancer or investigational drug therapy
- Concurrent dexamethasone allowed provided patient is on a stable or decreasing dose for ≥ 2 weeks prior to study registration
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
No publications provided
| 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 |
Keywords provided by Pediatric Brain Tumor Consortium:
|
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 |
Additional relevant MeSH terms:
|
Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms by Site Neoplasms Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013