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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/NCT00100802




Registration number
NCT00100802
Ethics application status
Date submitted
6/01/2005
Date registered
7/01/2005
Date last updated
15/02/2023

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
NCI-2012-02645
Secondary ID [2] 0 0
ACNS0423
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaplastic Astrocytoma 0 0
Central Nervous System Neoplasm 0 0
Glioblastoma 0 0
Gliosarcoma 0 0
Spinal Cord Neoplasm 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Children's - Brain
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Laboratory Biomarker Analysis
Treatment: Drugs - Lomustine
Treatment: Other - Radiation Therapy
Treatment: Drugs - Temozolomide

Experimental: Treatment (lomustine, temozolomide, radiation therapy) - Patients receive oral temozolomide once daily on days 1-42. Patients also undergo concurrent radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33 and 36-40. Patients who did not undergo prior gross total resection also undergo boost radiotherapy once daily on days 43-47. Four weeks after completion of chemoradiotherapy, patients receive oral temozolomide once daily on days 1-5 and oral lomustine on day 1. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.


Other interventions: Laboratory Biomarker Analysis
Correlative studies

Treatment: Drugs: Lomustine
Given PO

Treatment: Other: Radiation Therapy
Undergo radiation therapy

Treatment: Drugs: Temozolomide
Given PO
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
One Year Overall Survival
Timepoint [1] 0 0
One year
Primary outcome [2] 0 0
Occurrence of Death Attributable 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
- 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

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

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

- At least 8 weeks

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

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

- Hemoglobin = 8 g/dL (transfusions allowed)

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

- ALT = 2.5 times ULN

- Albumin = 2 g/dL

- Creatinine = 1.5 times ULN

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

- No evidence of dyspnea at rest

- No exercise intolerance

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

- 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

- No prior biologic agents

- No prior chemotherapy

- Prior corticosteroids allowed

- No concurrent corticosteroids as an antiemetic

- Concurrent corticosteroids allowed only for treatment of increased intracranial
pressure

- No concurrent radiotherapy using cobalt-60

- See Disease Characteristics

- 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
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 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
21/03/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2017
Sample size
Target
Accrual to date
Final
118
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Pennsylvania

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
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. 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.
Trial website
https://clinicaltrials.gov/ct2/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
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Regina I Jakacki
Address 0 0
Children's Oncology Group
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/NCT00100802