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SCH 66336 in Treating Children With Recurrent or Progressive Brain Tumors
This study has been completed.
First Received: May 6, 2001   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Pediatric Brain Tumor Consortium
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00015899
  Purpose

RATIONALE: SCH 66336 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: This phase I trial is studying the side effects and best dose of SCH 66336 in treating children with recurrent or progressive brain tumors.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: lonafarnib
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Trial Of Escalating Oral Doses Of SCH 66336 In Pediatric Patients With Refractory Or Recurrent Brain Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2002
Detailed Description:

OBJECTIVES:

  • Determine the qualitative and quantitative toxicity of SCH 66336 in children with recurrent or progressive brain tumors.
  • Determine the maximum tolerated dose of this drug in these patients.
  • Determine the pharmacokinetics of this drug with and without dexamethasone in these patients.
  • Determine the efficacy of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive oral SCH 66336 twice daily. Treatment repeats every 4 weeks for a total of 26 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 1-6 patients receive escalating doses of SCH 66336 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which it is predicted that 20% of patients may experience dose-limiting toxicity. An additional 6 patients are treated at the determined MTD.

Patients are followed within 30 days and then for up to 3 months.

PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed recurrent or progressive (refractory) brain tumors

    • Histologic confirmation waived for brainstem gliomas
  • Bone marrow involvement allowed if transfusion independent

PATIENT CHARACTERISTICS:

Age:

  • 21 and under

Performance status:

  • Lansky 60-100% OR
  • Karnofsky 60-100%

Life expectancy:

  • More than 8 weeks

Hematopoietic:

  • See Disease Characteristics
  • Absolute neutrophil count greater than 1,000/mm^3
  • Platelet count greater than 75,000/mm^3
  • Hemoglobin greater than 9 g/dL

Hepatic:

  • Bilirubin no greater than upper limit of normal
  • SGPT and SGOT less than 2.5 times normal
  • Albumin greater than 3 g/dL
  • PT/PTT no greater than 120% upper limit of normal
  • No overt hepatic disease

Renal:

  • Creatinine no greater than 1.5 times normal OR
  • Glomerular filtration rate greater than 70 mL/min
  • No overt renal disease

Cardiovascular:

  • No overt cardiac disease

Pulmonary:

  • No overt pulmonary disease

Other:

  • Neurologic deficits allowed if stable for at least 1 week prior to study
  • More than 3rd percentile weight for height
  • Able to swallow pills
  • No uncontrolled infection
  • No known or suspected allergy to poloxamer 188, croscarmellose sodium, silicon dioxide, or magnesium stearate I
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for up to 10 weeks after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • More than 6 months since prior bone marrow transplantation
  • More than 1 week since prior growth factors

Chemotherapy:

  • At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered

Endocrine therapy:

  • Concurrent dexamethasone allowed if on stable dose for at least 1 week prior to study
  • Concurrent oral contraceptives or other hormonal contraceptive methods allowed

Radiotherapy:

  • More than 6 weeks since prior substantial bone marrow radiotherapy
  • More than 3 months since prior craniospinal radiotherapy (more than 24 Gy) or total body irradiation
  • More than 2 weeks since prior focal radiotherapy for symptomatic metastatic sites

Surgery:

  • Not specified

Other:

  • No concurrent enzyme-inducing anticonvulsant drugs
  • No other concurrent anticancer or experimental drug therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00015899

Locations
United States, California
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94143-0372
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
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, 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, 38105-2794
United States, Texas
Texas Children's Cancer Center
Houston, Texas, United States, 77030-2399
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Pediatric Brain Tumor Consortium
Investigators
Study Chair: Mark W. Kieran, MD, PhD Dana-Farber Cancer Institute
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000068571, PBTC-003, SPRI-P02201
Study First Received: May 6, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00015899     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood craniopharyngioma
childhood central nervous system germ cell tumor
childhood oligodendroglioma
childhood choroid plexus tumor
childhood grade I meningioma
childhood grade II meningioma
childhood grade III meningioma
recurrent childhood cerebellar astrocytoma
recurrent childhood cerebral astrocytoma
recurrent childhood medulloblastoma
recurrent childhood visual pathway and hypothalamic glioma
recurrent childhood ependymoma
childhood atypical teratoid/rhabdoid tumor
childhood spinal cord neoplasm

Study placed in the following topic categories:
Choroid Plexus Neoplasms
Rhabdoid Tumor
Astrocytoma
Spinal Cord Neoplasm
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Recurrence
Ependymoma
Brain Neoplasms
Medulloblastoma
Craniopharyngioma
Spinal Cord Neoplasms
Oligodendroglioma
Meningioma
Glioma
Nervous System Neoplasms

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

ClinicalTrials.gov processed this record on August 25, 2009