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SCH 66336 in Treating Children With Recurrent or Progressive Brain Tumors
This study has been completed.
Study NCT00015899   Information provided by National Cancer Institute (NCI)
First Received: May 6, 2001   Last Updated: July 23, 2008   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

May 6, 2001
July 23, 2008
January 2002
 
 
Complete list of historical versions of study NCT00015899 on ClinicalTrials.gov Archive Site
 
 
 
SCH 66336 in Treating Children With Recurrent or Progressive Brain Tumors
Phase I Trial Of Escalating Oral Doses Of SCH 66336 In Pediatric Patients With Refractory Or Recurrent Brain Tumors

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.

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.

Phase I
Interventional
Treatment
Brain and Central Nervous System Tumors
Drug: lonafarnib
 
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 National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
up to 21 Years
No
 
United States
 
 
NCT00015899
 
PBTC-003, SPRI-P02201
Pediatric Brain Tumor Consortium
National Cancer Institute (NCI)
Study Chair: Mark W. Kieran, MD, PhD Dana-Farber Cancer Institute
National Cancer Institute (NCI)
July 2004

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.