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Brain and Central Nervous System TumorsPhase 1NCT00572182

MK0752 in Treating Young Patients With Recurrent or Refractory CNS Cancer

A Phase 1 study testing MK-0752 in people with Brain and Central Nervous System Tumors, run by Pediatric Brain Tumor Consortium at 12 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 21 years
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
MK-0752
Type of treatment
Pill or oral medicine
How many people
33 participants
Where
12 sitesUnited States
Study dates
Jul 2008to Feb 2011
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • NCI - Pediatric Oncology Branch

    Bethesda, Maryland, 20892

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

    Boston, Massachusetts, 02115

  • Children's Memorial Hospital - Chicago

    Chicago, Illinois, 60614

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229-3039

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Dan L. Duncan Cancer Center at Baylor College of Medicine

    Houston, Texas, 77030

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104-4318

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

  • Seattle Children's Hospital

    Seattle, Washington, 98105

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010-2970

Other trials in United States

About this study

Official title: A Phase I Study of MK-0752 in Pediatric Patients With Recurrent or Refractory CNS Malignancies

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.

Read the 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.

Being tested
MK-0752
Keywords
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
Medical subject headings
Central Nervous System Neoplasms, Astrocytoma, Choroid Plexus Neoplasms, Familial ependymoma, Medulloblastoma, Oligodendroglioma, Rhabdoid Tumor, Spinal Cord Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MK-0752Drug

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose

    Measured: First 28 days of treatment

  2. MK0752 systemic exposure

    Serial blood samples for pharmacokinetic studies of MK-0752 will be collected with the first dose of course 1 at pre-specified times.

    Measured: Day 1 of course 1

Secondary outcomes (3)

  1. Pharmacokinetics

    Serial blood samples for pharmacokinetic studies of MK-0752 will be collected with the first dose of course 1 at pre-specified times.

    Measured: Day 1 of course 1

  2. Toxicity

    Measured: From day 1 of treatment until off study

  3. Objective response rate

    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.

    Measured: End of courses 2, 4, 6 and at the end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2007 (estimated)
  2. Study startJul 2008
  3. Primary completionFeb 2011
  4. Study completionFeb 2011

Why it stopped: This Phase I study was permanently closed to patient accrual on February 23, 2011, due to the discontinuation of support from MERCK.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00572182
Sponsor's protocol ID
CDR0000578114
Other IDs
U01CA081457, PBTC-024, NCI-09-C-0112
Status last verified
Mar 2012
First submitted
11 Dec 2007
Last updated
6 Mar 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-0752 in people with Brain and Central Nervous System Tumors, run by Pediatric Brain Tumor Consortium at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: This Phase I study was permanently closed to patient accrual on February 23, 2011, due to the discontinuation of support from MERCK.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (time frame: First 28 days of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00572182.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2012.

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