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Phase I Trial Of Escalating Oral Doses Of SCH 66336 In Pediatric Patients With Refractory Or Recurrent Brain Tumors


Phase 1
N/A
21 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors

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Trial Information

Phase I Trial Of Escalating Oral Doses Of SCH 66336 In Pediatric Patients With Refractory Or Recurrent Brain Tumors


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Outcome Measure:

Toxicities of SCH 66336 in children and adolescents with refractory CNS cancers

Safety Issue:

Yes

Principal Investigator

Mark W. Kieran, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000068571

NCT ID:

NCT00015899

Start Date:

January 2002

Completion Date:

March 2007

Related Keywords:

  • Brain and Central Nervous System Tumors
  • 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
  • Brain Neoplasms
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location
Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Children's National Medical Center Washington, District of Columbia  20010-2970
Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - Seattle Seattle, Washington  98105
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston, Massachusetts  02115
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794
Texas Children's Cancer Center Houston, Texas  77030-2399
UCSF Comprehensive Cancer Center San Francisco, California  94115