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A Trial of 06-BG and BCNU in Children With CNS Tumors

Phase 1
21 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

A Trial of 06-BG and BCNU in Children With CNS Tumors


I. Determine the maximum tolerated dose and the dose limiting toxicity of carmustine
administered after O6-benzylguanine in children with refractory primary CNS tumors.

II. Determine a safe and tolerable dose of carmustine administered after O6-benzylguanine to
be used in phase II studies.

III. Determine the pharmacokinetics of O6-benzylguanine and its metabolite,
O6-benzyl-8-oxoguanine, in these patients.

IV. Seek preliminary evidence of antitumor activity of this regimen in these patients.

V. Evaluate the acute and chronic toxicities, and describe cumulative toxicity, in patients
treated with multiple courses of this regimen.

OUTLINE: This is a dose escalation study of carmustine.

Patients receive O6-benzylguanine IV over 1 hour, then, 1 hour later, carmustine IV is
administered over 1 hour. Treatment is repeated every 6 weeks for up to 1 year in the
absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients each
receive escalating doses of carmustine until the maximum tolerated dose (MTD) is reached.
The MTD is defined as the dose level at which fewer than 2 of 6 patients experience dose
limiting toxicity (DLT). If myelosuppression is the DLT, stratum 1 is closed and patients
are accrued to stratum 2. If neutropenia is the DLT in stratum 2, patients receive
filgrastim (G-CSF) subcutaneously beginning on day 2 and continuing until blood counts
recover. Patients are followed every 6 months for 4 years, then annually thereafter.

Inclusion Criteria


- Histologically or cytologically proven CNS tumor that is refractory to conventional
therapy or for which no effective therapy is known

- Histological requirement may be waived for brainstem and optic gliomas

- Stratum 2: No bone marrow involvement


- Age: 21 and under

- Performance status: Karnofsky 50-100% OR Lansky 50-100%

- Life expectancy: At least 8 weeks

- Absolute neutrophil count at least 1500/mm3

- Platelet count at least 100,000/mm3 (stratum 2: at least 125,000/mm3)

- Hemoglobin at least 8 g/dL

- Bilirubin less than 1.5 mg/dL

- SGOT/SGPT no greater than 2.5 times normal

- Creatinine or GFR normal for age

- If required, DLCO must be 80% of normal and patient old enough to cooperate for DLCO

- Neurologic deficits must be stable for at least 2 weeks prior to study

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study


- At least 7 days since prior biologic therapy or immunotherapy and recovered

- At least 6 months since prior bone marrow transplant (stratum 1 only)

- At least 7 days since prior growth factors

- No concurrent filgrastim (G-CSF) prophylaxis

- Stratum 2: No prior bone marrow transplantation

- At least 2 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea)
and recovered

- Stratum 2: No greater than 2 prior chemotherapy regimens

- No prior nitrosourea therapy

- If receiving dexamethasone, must be on stable or decreasing dose for at least 2 weeks
prior to study

- At least 2 weeks since prior local palliative radiotherapy (small port)

- At least 6 months since prior substantial bone marrow radiation, total body
irradiation, hemipelvic radiotherapy, or total abdominal/pelvic/chest or mantle/Y
ports radiotherapy

- Recovered from prior radiotherapy

- Stratum 2: No prior central axis radiation

- No other concurrent anticancer or investigational agents

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Denise Adams, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Vermont


United States: Food and Drug Administration

Study ID:




Start Date:

May 1999

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • childhood craniopharyngioma
  • childhood central nervous system germ cell tumor
  • childhood oligodendroglioma
  • childhood choroid plexus tumor
  • recurrent childhood brain stem glioma
  • recurrent childhood supratentorial primitive neuroectodermal tumor
  • recurrent childhood visual pathway glioma
  • recurrent childhood cerebellar astrocytoma
  • recurrent childhood cerebral astrocytoma
  • recurrent childhood medulloblastoma
  • recurrent childhood ependymoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



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