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SCH 66336 in Treating Children With Recurrent or Progressive Brain Tumors

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ClinicalTrials.gov Identifier: NCT00015899
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 14, 2009
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Pediatric Brain Tumor Consortium

Brief Summary:

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 or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: lonafarnib Phase 1

Detailed Description:

OBJECTIVES:

  • Determine the qualitative and quantitative toxicity of SCH 66336 in children with recurrent or progressive brain tumors.
  • Estimate the maximum tolerated dose of this drug in these patients.
  • Describe the pharmacokinetics of this drug with and without dexamethasone in these patients.
  • Investigate 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 of the last administration of the study drug and then for up to 3 months.

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Primary Purpose: Treatment
Official Title: Phase I Trial Of Escalating Oral Doses Of SCH 66336 In Pediatric Patients With Refractory Or Recurrent Brain Tumors
Study Start Date : January 2002
Actual Primary Completion Date : September 2005
Actual Study Completion Date : March 2007



Intervention Details:
  • Drug: lonafarnib
    Other Name: SCH 66336


Primary Outcome Measures :
  1. Toxicities of SCH 66336 in children and adolescents with refractory CNS cancers
  2. Maximum tolerated dose of SCH 66336 [ Time Frame: Four weeks ]
  3. Pharmacokinetics of SCH 66336

Secondary Outcome Measures :
  1. Tumor response to SCH 66336


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Cancer Institute (NCI)
Investigators
Study Chair: Mark W. Kieran, MD, PhD Dana-Farber Cancer Institute

Publications of Results:
Responsible Party: James M. Boyett/PBTC Operations and Biostatistics Center Executive Director, Pediatric Brain Tumor Consortium
ClinicalTrials.gov Identifier: NCT00015899     History of Changes
Other Study ID Numbers: CDR0000068571
PBTC-003
SPRI-P02201
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: October 14, 2009
Last Verified: October 2009

Keywords provided by Pediatric Brain Tumor Consortium:
childhood central nervous system germ cell tumor
childhood choroid plexus tumor
recurrent childhood cerebral astrocytoma
childhood atypical teratoid/rhabdoid tumor
childhood spinal cord neoplasm
childhood craniopharyngioma
childhood oligodendroglioma
childhood grade I meningioma
childhood grade II meningioma
childhood grade III meningioma
recurrent childhood cerebellar astrocytoma
recurrent childhood medulloblastoma
recurrent childhood visual pathway and hypothalamic glioma
recurrent childhood ependymoma

Additional relevant MeSH terms:
Brain Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lonafarnib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action