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SCH 66336 in Treating Children With Recurrent or Progressive Brain Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 6, 2001
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date October 14, 2009
Study Start Date  ICMJE January 2002
Actual Primary Completion Date September 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2009)
  • Toxicities of SCH 66336 in children and adolescents with refractory CNS cancers
  • Maximum tolerated dose of SCH 66336 [ Time Frame: Four weeks ]
  • Pharmacokinetics of SCH 66336
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00015899 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2009)
Tumor response to SCH 66336
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SCH 66336 in Treating Children With Recurrent or Progressive Brain Tumors
Official Title  ICMJE Phase I Trial Of Escalating Oral Doses Of SCH 66336 In Pediatric Patients With Refractory Or Recurrent Brain Tumors
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Brain and Central Nervous System Tumors
Intervention  ICMJE Drug: lonafarnib
Other Name: SCH 66336
Study Arms  ICMJE Not Provided
Publications * Kieran MW, Packer RJ, Onar A, Blaney SM, Phillips P, Pollack IF, Geyer JR, Gururangan S, Banerjee A, Goldman S, Turner CD, Belasco JB, Broniscer A, Zhu Y, Frank E, Kirschmeier P, Statkevich P, Yver A, Boyett JM, Kun LE. Phase I and pharmacokinetic study of the oral farnesyltransferase inhibitor lonafarnib administered twice daily to pediatric patients with advanced central nervous system tumors using a modified continuous reassessment method: a Pediatric Brain Tumor Consortium Study. J Clin Oncol. 2007 Jul 20;25(21):3137-43.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 13, 2009)
53
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2007
Actual Primary Completion Date September 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00015899
Other Study ID Numbers  ICMJE CDR0000068571
PBTC-003
SPRI-P02201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James M. Boyett/PBTC Operations and Biostatistics Center Executive Director, Pediatric Brain Tumor Consortium
Study Sponsor  ICMJE Pediatric Brain Tumor Consortium
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Mark W. Kieran, MD, PhD Dana-Farber Cancer Institute
PRS Account Pediatric Brain Tumor Consortium
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP