MK0752 in Treating Young Patients With Recurrent or Refractory CNS Cancer

NCT ID: NCT00572182

Last Updated: 2012-03-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2011-02-28

Brief Summary

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.

Detailed Description

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.

Conditions

Brain and Central Nervous System Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

MK-0752

This is a dose escalation study. Patients may receive 150, 200, 260 or 325 mg/m2 orally for 3 consecutive days of every 7 days for 28 days (dosing regimen 1 - closed to accrual 2/23/2010) or 800, 1000, 1400, or 1800 mg/m2 orally once weekly for 28 days (1 course). In the absence of unacceptable toxicity or disease progression, treatment may continue for 6 courses.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Pediatric Brain Tumor Consortium

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maryam Fouladi, MD

Role: STUDY_CHAIR

Children's Hospital Medical Center, Cincinnati

Locations

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Children's Memorial Hospital - Chicago

Chicago, Illinois, United States

NCI - Pediatric Oncology Branch

Bethesda, Maryland, United States

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Dan L. Duncan Cancer Center at Baylor College of Medicine

Houston, Texas, United States

Seattle Children's Hospital

Seattle, Washington, United States

Countries

United States

Other Identifiers

U01CA081457

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PBTC-024

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-09-C-0112

Identifier Type: -

Identifier Source: secondary_id

CDR0000578114

Identifier Type: -

Identifier Source: org_study_id

NCT00923208

Identifier Type: -

Identifier Source: nct_alias