Know Cancer

or
forgot password

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


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

Thank you

Trial Information

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


OBJECTIVES:

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


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- 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
test

- 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

PRIOR CONCURRENT THERAPY:

- 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:

Interventional

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

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01842

NCT ID:

NCT00003765

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Stanford University Medical CenterStanford, California  94305-5408
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
Children's Hospital of MichiganDetroit, Michigan  48201
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Boston Floating Hospital Infants and ChildrenBoston, Massachusetts  02111
University of Florida Health Science CenterGainesville, Florida  32610-0296
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Hackensack University Medical CenterHackensack, New Jersey  07601
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's Hospital of Orange CountyOrange, California  92668
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
Children's Hospital Medical Center - CincinnatiCincinnati, Ohio  45229-3039
Children's Hospital of ColumbusColumbus, Ohio  43205-2696
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Cardinal Glennon Children's HospitalSaint Louis, Missouri  63104
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Texas Children's Cancer CenterHouston, Texas  77030-2399
Columbia Presbyterian HospitalNew York, New York  10032
Children's Memorial Hospital, ChicagoChicago, Illinois  60614
Primary Children's Medical CenterSalt Lake City, Utah  84113-1100
City of Hope National Medical CenterLos Angeles, California  91010
Graham Children's Health CenterAsheville, North Carolina  28801