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PHASE II STUDY OF CARBOPLATIN (CBDCA) IN THE TREATMENT OF CHILDREN AND ADULTS WITH PROGRESSIVE LOW GRADE GLIOMAS


Phase 2
N/A
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

PHASE II STUDY OF CARBOPLATIN (CBDCA) IN THE TREATMENT OF CHILDREN AND ADULTS WITH PROGRESSIVE LOW GRADE GLIOMAS


OBJECTIVES: I. Assess the response to carboplatin (CBDCA) in patients with progressive
low-grade gliomas. II. Assess the activity of CBDCA in stabilizing the growth of these
tumors.

OUTLINE: Single-Agent Chemotherapy. Carboplatin, CBDCA, NSC-241240.

PROJECTED ACCRUAL: A total of 25 evaluable patients will be entered if there is at least 1
response in the first 9 patients.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed primary intracranial low-grade glioma
(i.e., astrocytoma or oligodendroglioma) No more than 2 years since tissue diagnosis
Biopsy not required for intrinsic chiasmatic mass or tumor infiltration along the
posterior optic tracts Evidence of progressive disease by at least one of the following:
Papilledema or other clinical sign of increased intracranial pressure Documented change in
neuroimaging studies, e.g.: Hydrocephalus 25% increase in product of maximum perpendicular
diameters of tumor The following are required in patients with optic pathway gliomas:
Progressive loss of vision documented by an ophthalmologist, i.e.: Doubling of octaves
(e.g., 20/20 to 20/40 or 20/40 to 20/80) on 2 successive visits Loss of visual acuity not
explainable by other causes, e.g., media abnormalities or amblyopia Greater than 3 mm
increase in proptosis At least 2 mm increase in diameter of optic nerve on neuroimaging
Increase in distribution of tumor involving the optic tracts or optic radiations
demonstrated by CT or MRI using T1 (with or without contrast) or T2 imaging

PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 70%-100% Life
expectancy: At least 12 weeks Hematopoietic: ANC at least 1,500 Platelets at least 100,000
Hemoglobin at least 8.0 g/dL Hepatic: Bilirubin less than 1.5 times normal ALT less than
1.5 times normal Renal: Creatinine less than 1.5 mg/dL Other: Negative pregnancy test
required of fertile women Effective contraception required of fertile patients

PRIOR CONCURRENT THERAPY: At least 12 weeks since radiotherapy (4 weeks since other
therapy) and recovered Prior chemotherapy allowed with subsequent disease progression

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Henry S. Friedman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke University

Authority:

United States: Federal Government

Study ID:

CDR0000064682

NCT ID:

NCT00002749

Start Date:

February 1993

Completion Date:

March 2000

Related Keywords:

  • Brain and Central Nervous System Tumors
  • childhood low-grade cerebral astrocytoma
  • recurrent adult brain tumor
  • adult brain stem glioma
  • childhood oligodendroglioma
  • untreated childhood brain stem glioma
  • recurrent childhood brain stem glioma
  • untreated childhood visual pathway glioma
  • recurrent childhood visual pathway glioma
  • untreated childhood cerebellar astrocytoma
  • recurrent childhood cerebellar astrocytoma
  • recurrent childhood cerebral astrocytoma
  • adult anaplastic astrocytoma
  • adult oligodendroglioma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710