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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00100802




Registration number
NCT00100802
Ethics application status
Date submitted
6/01/2005
Date registered
7/01/2005
Date last updated
7/08/2019

Titles & IDs
Public title
Radiation Therapy, Temozolomide, and Lomustine in Treating Young Patients With Newly Diagnosed Gliomas
Scientific title
A Phase II Study of Concurrent Radiation and Temozolomide Followed By Temozolomide and CCNU in the Treatment of Children With High-Grade Glioma
Secondary ID [1] 0 0
CDR0000407744
Secondary ID [2] 0 0
ACNS0423
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Tumors 0 0
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 - lomustine
Treatment: Drugs - temozolomide
Treatment: Surgery - adjuvant therapy
Treatment: Other - radiation therapy

Experimental: Surgery, Chemoradiotherapy, Rest, Maintenance, FUP - Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.


Treatment: Drugs: lomustine
Capsule

Treatment: Drugs: temozolomide
Capsule

Treatment: Surgery: adjuvant therapy


Treatment: Other: radiation therapy


Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Intervention code [3] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
One Year Overall Survival - Estimated one year survival using the Kaplan-Meier methodology.
Timepoint [1] 0 0
One year
Primary outcome [2] 0 0
Occurrence of Death Attributable to Complications of Protocol Therapy - Number of deaths due to complications of protocol therapy.
Timepoint [2] 0 0
While receiving protocol therapy (up to 301 days excluding delays) or within 30 days of Termination of Protocol Therapy

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed, newly diagnosed high-grade glioma of 1 of the following
histologies:

- Anaplastic astrocytoma

- Glioblastoma multiforme

- Gliosarcoma

- Primary spinal cord malignant gliomas allowed

- No primary brainstem tumors

- Has undergone surgical resection or biopsy of the tumor within the past 31 days

- Pre-operative and post-operative brain MRI with and without gadolinium-contrast
OR pre-operative and post-operative spine MRI for spinal cord primaries

- Post-operative MRI not required for patients who undergo biopsy only

- No evidence of neuraxis dissemination

- Spine MRI and cerebrospinal fluid cytology required only if clinically indicated

PATIENT CHARACTERISTICS:

Age

- 3 to 21

Performance status

- Karnofsky 50-100% (for patients > 16 years of age)

- Lansky 50-100% (for patients = 16 years of age)

Life expectancy

- At least 8 weeks

Hematopoietic

- Absolute neutrophil count = 1,000/mm^3

- Platelet count = 100,000/mm^3 (transfusion independent)

- Hemoglobin = 8 g/dL (transfusions allowed)

Hepatic

- Bilirubin = 1.5 times upper limit of normal (ULN)

- ALT = 2.5 times ULN

- Albumin = 2 g/dL

Renal

- Creatinine = 1.5 times ULN OR

- Creatinine clearance or radioisotope glomerular filtration rate = lower limit of
normal

Pulmonary

- No evidence of dyspnea at rest

- No exercise intolerance

- Pulse oximetry = 94% (if determination is clinically indicated)

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 2 months after study
participation

- Able to swallow oral medication

- Seizures allowed provided they are well controlled with anticonvulsants

- No hypersensitivity to temozolomide

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior biologic agents

Chemotherapy

- No prior chemotherapy

Endocrine therapy

- Prior corticosteroids allowed

- No concurrent corticosteroids as an antiemetic

- Concurrent corticosteroids allowed only for treatment of increased intracranial
pressure

Radiotherapy

- No concurrent radiotherapy using cobalt-60

Surgery

- See Disease Characteristics

Other

- No other prior treatment

- No concurrent phenobarbital or cimetidine

- No concurrent co-trimoxazole for Pneumocystis carinii pneumonia prophylaxis during
study chemoradiotherapy
Minimum age
3 Years
Maximum age
21 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
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 2
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [2] 0 0
Westmead Institute for Cancer Research at Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Royal Children's Hospital - Herston, Brisbane
Recruitment hospital [4] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment hospital [5] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2310 - Newcastle
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4029 - Herston, Brisbane
Recruitment postcode(s) [4] 0 0
5006 - North Adelaide
Recruitment postcode(s) [5] 0 0
6001 - Perth
Recruitment outside Australia
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Alabama
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Arizona
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Oregon
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Geneva

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in
chemotherapy, such as temozolomide and lomustine, work in different ways to stop the growth
of tumor cells, either by killing the cells or by stopping them from dividing. Giving
radiation therapy together with temozolomide and lomustine after surgery may kill any
remaining tumor cells.

PURPOSE: This phase II trial is studying how well giving radiation therapy together with
temozolomide and lomustine works in treating young patients with newly diagnosed gliomas.
Trial website
https://clinicaltrials.gov/show/NCT00100802
Trial related presentations / publications
Pollack IF, Hamilton RL, Burger PC, Brat DJ, Rosenblum MK, Murdoch GH, Nikiforova MN, Holmes EJ, Zhou T, Cohen KJ, Jakacki RI; Children's Oncology Group. Akt activation is a common event in pediatric malignant gliomas and a potential adverse prognostic marker: a report from the Children's Oncology Group. J Neurooncol. 2010 Sep;99(2):155-63. doi: 10.1007/s11060-010-0297-3. Epub 2010 Jul 4.
Pollack IF, Hamilton RL, Sobol RW, Nikiforova MN, Nikiforov YE, Lyons-Weiler MA, LaFramboise WA, Burger PC, Brat DJ, Rosenblum MK, Gilles FH, Yates AJ, Zhou T, Cohen KJ, Finlay JL, Jakacki RI; Children's Oncology Group. Mismatch repair deficiency is an uncommon mechanism of alkylator resistance in pediatric malignant gliomas: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2010 Dec 1;55(6):1066-71. doi: 10.1002/pbc.22634.
Public notes

Contacts
Principal investigator
Name 0 0
Regina Jakacki, MD
Address 0 0
University of Pittsburgh
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
Other publications