Clinical Trials Office

PBTC-024: Phase I Study of MK-0752 in Pediatric Patients With Recurrent or Refractory CNS Malignancies

What is the purpose of this study?

Primary

1. To estimate the maximum tolerated dose (MTD) and recommended phase II dose of MK-0752 administered for 3 consecutive days of every 7 days in 28 day courses to young patients with recurrent or refractory CNS malignancies.

2. 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.

3. To compare the MK0752 systemic exposure attained with each dosage level on the different dosing regimens. malignancies.

Secondary

1. To characterize the pharmacokinetics of MK-0752.

2. To document and describe toxicities associated with MK-0752.

3. To preliminarily define the antitumor activity of MK-0752 within the confines of a phase I setting.

Who can participate?

About 47 people will participate in this study at Cincinnati Children’s Hospital.

Entry 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
Age

  • 3 to 21 years of age.

Performance Status

  • Karnofsky performance status (PS) or Lansky PS 60-100%.

Life Expectancy

  • Not specified.

Hematopoietic

  • Absolute neutrophil count ≥1,000/μ.
  • Platelet count ≥100,000/μ (unsupported).
  • Hemoglobin ≥8 g/dL (RBC transfusions allowed).

Hepatic

  • Bilirubin ≤1.5 times upper limit of normal (ULN) for age.
  • ALT ≤2.5 times ULN for age.
  • Albumin ≥2.5 g/dL.

Renal

  • Serum creatinine normal for age OR glomerular filtration rate ≥70 mL/min/1.73m2.

Other

  • Not pregnant or nursing.
  • Negative pregnancy test.
  • Fertile patients must use effective contraception.
  • 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 MK-0752.

Ages

  • From 3 To 21  years old

Conditions

  • Adult Studies
  • Cancer - Brain and Spinal Tumors
  • Medications

What is involved?

This is a multicenter study. Patients receive oral MK-0752 once daily on days 1-3, 8-10, 15-17, and 22-24 or days 1,8,15 and 22. Treatment repeats every 28 days for up to 19 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 30 days.

Who should I contact for more information?

Cincinnati Children’s Hospital Medical Center
Division of Hematology/Oncology
3333 Burnet Ave., Cincinnati, OH 45229-3039
Phone: 513-636-2799
cancer@cchmc.org

Where can I find additional information?