Know Cancer

forgot password

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

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

Thank you

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



Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Stanford University Medical Center Stanford, California  94305-5408
Emory University Hospital - Atlanta Atlanta, Georgia  30322
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Johns Hopkins Oncology Center Baltimore, Maryland  21287
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Washington University School of Medicine Saint Louis, Missouri  63110
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Medical University of South Carolina Charleston, South Carolina  29425-0721
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611
Children's Hospital of Michigan Detroit, Michigan  48201
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
Midwest Children's Cancer Center Milwaukee, Wisconsin  53226
University of California San Diego Cancer Center La Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
State University of New York - Upstate Medical University Syracuse, New York  13210
Vanderbilt Cancer Center Nashville, Tennessee  37232-6838
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016
Boston Floating Hospital Infants and Children Boston, Massachusetts  02111
University of Florida Health Science Center Gainesville, Florida  32610-0296
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Dana-Farber Cancer Institute Boston, Massachusetts  02115
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Hackensack University Medical Center Hackensack, New Jersey  07601
Children's Hospital Los Angeles Los Angeles, California  90027-0700
Children's Hospital of Orange County Orange, California  92668
Children's National Medical Center Washington, District of Columbia  20010-2970
Children's Mercy Hospital Kansas City, Missouri  64108
Children's Hospital Medical Center - Cincinnati Cincinnati, Ohio  45229-3039
Children's Hospital of Columbus Columbus, Ohio  43205-2696
Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - Seattle Seattle, Washington  98105
Cardinal Glennon Children's Hospital Saint Louis, Missouri  63104
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
Cook Children's Medical Center - Fort Worth Fort Worth, Texas  76104
Texas Children's Cancer Center Houston, Texas  77030-2399
Columbia Presbyterian Hospital New York, New York  10032
Children's Memorial Hospital, Chicago Chicago, Illinois  60614
Primary Children's Medical Center Salt Lake City, Utah  84113-1100
City of Hope National Medical Center Los Angeles, California  91010
Graham Children's Health Center Asheville, North Carolina  28801