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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00003765




Registration number
NCT00003765
Ethics application status
Date submitted
1/11/1999
Date registered
27/04/2004
Date last updated
5/02/2013

Titles & IDs
Public title
O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors
Scientific title
A Trial of 06-BG and BCNU in Children With CNS Tumors
Secondary ID [1] 0 0
POG-9870
Secondary ID [2] 0 0
NCI-2012-01842
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain and Central Nervous System Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Children's - Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - O6-benzylguanine
Treatment: Drugs - carmustine

Experimental: Arm I - 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.


Treatment: Drugs: O6-benzylguanine


Treatment: Drugs: carmustine
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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
Minimum age
No limit
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/1999
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [2] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment postcode(s) [2] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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United States of America
State/province [2] 0 0
California
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United States of America
State/province [3] 0 0
District of Columbia
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United States of America
State/province [4] 0 0
Florida
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Georgia
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United States of America
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Illinois
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Indiana
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United States of America
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Kansas
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United States of America
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Maryland
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Massachusetts
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United States of America
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Michigan
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Minnesota
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Mississippi
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Missouri
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New Jersey
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United States of America
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New York
Country [17] 0 0
United States of America
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North Carolina
Country [18] 0 0
United States of America
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Ohio
Country [19] 0 0
United States of America
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Oklahoma
Country [20] 0 0
United States of America
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Pennsylvania
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United States of America
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South Carolina
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Tennessee
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United States of America
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Texas
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Utah
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Washington
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United States of America
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Wisconsin
Country [27] 0 0
Canada
State/province [27] 0 0
Ontario
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Canada
State/province [28] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Government body
Name
National Cancer Institute (NCI)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Phase I trial to study the effectiveness of O6-benzylguanine and carmustine in treating
children who have refractory CNS tumors. Drugs used in chemotherapy use different ways to
stop tumor cells from dividing so they stop growing or die. Combining more than one drug may
kill more tumor cells.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00003765
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Denise Adams, MD
Address 0 0
University of Vermont
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00003765