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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/NCT00025324




Registration number
NCT00025324
Ethics application status
Date submitted
11/10/2001
Date registered
27/01/2003
Date last updated
18/12/2013

Titles & IDs
Public title
Chemotherapy, Surgery, Radiation Therapy and Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Primary CNS Germ Cell Tumors
Scientific title
Clinical Correlative Studies In Primary Central Nervous System Germ Cell Tumors: The Third International CNS Germ Cell Tumor Study Group Protocol
Secondary ID [1] 0 0
CHLA-NYU-0007H
Secondary ID [2] 0 0
CDR0000068950
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
Ovarian and primary peritoneal
Cancer 0 0 0 0
Testicular
Cancer 0 0 0 0
Other cancer types
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
Other interventions - filgrastim
Treatment: Drugs - carboplatin
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - etoposide
Treatment: Drugs - thiotepa
Treatment: Surgery - autologous bone marrow transplantation
Treatment: Surgery - bone marrow ablation with stem cell support
Treatment: Surgery - conventional surgery
Treatment: Surgery - peripheral blood stem cell transplantation
Treatment: Other - radiation therapy

Other interventions: filgrastim


Treatment: Drugs: carboplatin


Treatment: Drugs: cyclophosphamide


Treatment: Drugs: etoposide


Treatment: Drugs: thiotepa


Treatment: Surgery: autologous bone marrow transplantation


Treatment: Surgery: bone marrow ablation with stem cell support


Treatment: Surgery: conventional surgery


Treatment: Surgery: peripheral blood stem cell transplantation


Treatment: Other: radiation therapy
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Treatment: Surgery
Intervention code [4] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed newly diagnosed primary CNS germ cell tumor OR

- Serum or cerebrospinal fluid (CSF) elevation of alpha-fetoprotein (AFP) or beta-human
chorionic gonadotropin (beta-HCG) greater than 50 ng/mL

- Low-risk disease:

- Histologically proven pure germinoma

- Localized, nonmetastatic disease

- Normal CSF

- Normal serum tumor markers

- Intermediate-risk disease:

- Histologically proven germinoma

- Beta-HCG-positive syncytiotrophoblastic giant cell component AND/OR

- CSF elevation of beta-HCG to less than 50 ng/mL

- High-risk disease:

- Histologically proven choriocarcinoma, endodermal sinus tumor, or embryonal
carcinoma

- Elevated serum and/or CSF AFP OR

- Elevated serum beta-HCG OR

- Elevated CSF beta-HCG greater than 50 ng/mL OR

- Disseminated disease by MRI and/or CSF cytology

PATIENT CHARACTERISTICS:

Age:

- Any age

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin less than 2.0 mg/dL

- Indirect hyperbilirubinemia due to Gilbert's syndrome is allowed

- AST and ALT less than 5 times upper limit of normal

Renal:

- Creatinine clearance greater than 60 mL/min

Cardiovascular:

- Cardiac function normal by echocardiogram

- No myocardial infarction or ischemia in patients over 30 years

- Fractional shortening greater than 30%

Other:

- No unacceptable morbidity of organ systems outside the CNS

- Not pregnant

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- No concurrent corticosteroids administered solely for antiemesis during study
chemotherapy

Radiotherapy:

- No prior cranial radiotherapy

Surgery:

- Not specified
Minimum age
No limit
Maximum age
No limit
Sex
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
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2000
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)
WA
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Virginia
Country [3] 0 0
Canada
State/province [3] 0 0
Alberta

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Hospital Los Angeles
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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Peripheral stem cell transplantation or bone marrow transplantation
may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
Radiation therapy uses high-energy x-rays to damage tumor cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy, surgery, radiation
therapy, and bone marrow or peripheral stem cell transplantation in treating patients who
have primary CNS germ cell tumors.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00025324
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jonathan L. Finlay, MB, ChB
Address 0 0
Children's Hospital Los Angeles
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/NCT00025324