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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01014767




Registration number
NCT01014767
Ethics application status
Date submitted
13/11/2009
Date registered
16/11/2009
Date last updated
21/07/2016

Titles & IDs
Public title
Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Choroid Plexus Tumors
Scientific title
CPT-SIOP-2009: Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Patients With Choroid Plexus Tumors
Secondary ID [1] 0 0
CPT-SIOP-2009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Cancer 0 0
Choroid Plexus Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Dactinomycin
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Etoposide
Treatment: Drugs - Irinotecan
Treatment: Drugs - Leucovorin
Treatment: Drugs - Methotrexate
Treatment: Drugs - Temozolomide
Treatment: Drugs - Vincristine

Experimental: Standard Arm (1) - Alternating chemotherapy cycles with etoposide 100 mg/m2 over 1 hour on days 1-5, carboplatin 350 mg/m2 over 2 hours on day 2 and 3, vincristine 1.5 mg/m2 on day 5 alternating with: etoposide 100 mg/m2 over 1 hour on days 1-5, cyclophosphamide 1 g/m2 over 1 hour on day 2 and 3, vincristine 1.5 mg/m2 on day 5. Six blocks are given in 4 week intervals (day1 to day1). Radiation is given between the second and the third cycle only to a small subgroup of patients defined by age histology staging and response to the first to cycles of chemotherapy.

Experimental: Doxorubicin/cisplatin arm (2) - Doxorubicin 25 mg/m²/day over 12 hrs on days 1-3, Dactinomycin 45 µg/kg/day (max. 2 mg), i.v. on day 1, and Cisplatin 70 mg/m²/d over 6 hrs on day 4, and Vincristine 1.5 mg/m²/day (max. 2 mg), i.v. on days 8, 15. An identical second cycle is started on day 28 if the side effects allow it. The further treatment is identical to the standard arm with four more cycles of chemotherapy following radiation in some of the patients in all treatment arms.

Experimental: Methotrexate Arm (3) - Methotrexate 5g/m^2 over 24 hours with leucovorin rescue at hour 42 given three times on days 1 15 and 29. The further treatment is identical in all four treatment arms.

Experimental: Temozolomide Irinotecan arm (4) - Temozolomide is given at 150 mg/m2/day x 5 days orally and combined with irinotecan 50 mg/m2/day x 5 days as one hour infusions. Two of these cycles are followed by the common radiation - four cycle chemotherapy protocol.


Treatment: Drugs: Carboplatin
Standard Arm, Cycle 2: 350 mg/m2 IV over 2 hours on day 2 and 3
All Arms, Cycles 4 & 6: 350 mg/m2 IV over 2 hours on day 2 and 3

Treatment: Drugs: Cisplatin
Cycles 1 & 2: 70 mg/m²/d IV over 6 hours on day 4

Treatment: Drugs: Cyclophosphamide
Standard Arm, Cycle 1: 1 g/m^2 IV over 1 hour on day 2 and 3
All Arms, Cycles 3 & 5: 1 g/m^2 IV over 1 hour on day 2 and 3

Treatment: Drugs: Dactinomycin
Cycles 1 & 2: 45 µg/kg/day (max. 2 mg), IV on day 1

Treatment: Drugs: Doxorubicin
Cycles 1 & 2: 25 mg/m²/day IV over 12 hrs on days 1-3

Treatment: Drugs: Etoposide
Standard Arm (1), Cycles 1 & 2:
100 mg/m2 IV over 1 hour on days 1-5
All Arms, Cycles 4-6:
100 mg/m2 IV over 1 hour on days 1-5

Treatment: Drugs: Irinotecan
Temozolomide Irinotecan arm (4), Cycles 1 & 2:
50 mg/m2/day x 5 days as 1 hour IV infusions

Treatment: Drugs: Leucovorin
Given with Methotrexate as leucovorin rescue at hour 42 given three times on days 1, 15 and 29.

Treatment: Drugs: Methotrexate
5g/m2 IV over 24 hours with leucovorin rescue at hour 42 given three times on days 1, 15 and 29.

Treatment: Drugs: Temozolomide
150 mg/m2/day x 5 days orally and combined with irinotecan 50 mg/m2/day IV x 5 days as one hour infusions.

Treatment: Drugs: Vincristine
Standard Arm (1), Cycles 1 & 2 : 1.5 mg/m^2 IV over 15 minutes on day 5
Doxorubicin/cisplatin arm (2), Cycles 1 & 2: 1.5 mg/m^2/day (max. 2 mg), i.v. on days 8, 15
For all Groups, Cycles 3 - 6: 1.5 mg/m2 IV over 15 minutes on day 5

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

Outcomes
Primary outcome [1] 0 0
Time to Disease Progression
Timepoint [1] 0 0
Till disease progression or death (up to 6 cycles of 28-day treatment)
Primary outcome [2] 0 0
Toxicity during first 4 months of therapy
Timepoint [2] 0 0
4 Months

Eligibility
Key inclusion criteria
1. Histological diagnosis of a choroid plexus tumor by a local
pathologist/neuropathologist. This includes choroid plexus papilloma, atypical choroid
plexus papilloma, anaplastic choroid plexus papilloma, malignant choroid plexus
papilloma, and choroid plexus carcinoma.

2. Slides have been sent to the pathology reference center (by declaration of the sending
center).

3. Informed consent signed

4. The first registration on the study was completed or was sent with the same mail or
fax or electronic registration.

5. The reference center has confirmed the receipt of slides sent.

6. The postoperative imaging has been done and the result is available.

7. Disease status and histology: The patient is suffering from either choroid plexus
carcinoma of any stage, OR an atypical choroid plexus papilloma with tumor residual
after maximal possible surgical resection, OR a primary metastatic atypical choroid
plexus papilloma. OR a first recurring choroid plexus papilloma that is either not
resectable or was metastatic, OR a second recurrence of any choroid plexus tumor.

8. The agreement of patient or legal guardian has been documented according to the local
guidelines.

9. For females in reproductive age: pregnancy test negative (both urine or blood test
acceptable)

10. Females in reproductive age, patients must agree to use a medically accepted method of
contraception while receiving protocol-specified medication.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous chemotherapy

2. Previous radiation therapy of the central nervous system

3. White blood cell count < 2000/ uL

4. Platelet count < 85 000 / uL

5. Inadequate kidney function with Creatinine > age adapted upper normal range AND
creatinine clearance or GFR determined by nuclear medicine < 70 ml/min/1.73 m2 Body
surface area

6. Hearing loss more than 30 dB at 3000 Hz or more than 40 dB at 4000 Hz.

7. Echocardiography indicates myocardial dysfunction or weakness

8. Patients who are involuntarily hospitalized because of mental illness

9. Pregnancy

10. ALT or AST elevated higher than three times the upper normal level.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
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)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
Germany
State/province [3] 0 0
Regensburg
Country [4] 0 0
Hungary
State/province [4] 0 0
Budapest
Country [5] 0 0
New Zealand
State/province [5] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Other
Name
Tufts Medical Center
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a "tissue banking and data review" research study that also has a "clinical" research
part:

- The goal of the tissue banking part of this study is to store tissue in a research
tissue bank by the International Society for Pediatric Oncology (SIOP) at an
international reference center for choroid plexus tumors. The tissue will be used in
future research related to cancer.

- The goal of the data review part of this study is to collect information from the
medical records of patients with choroid plexus tumors, and to store the information in
SIOP databases for use in future research related to cancer.

- The goal of this clinical research study is to compare 4 chemotherapy treatments for
choroid plexus tumors. The safety and level of effectiveness of these study treatments
will be compared and studied. The study drugs include different combinations of
etoposide, carboplatin, vincristine, cyclophosphamide, methotrexate, doxorubicin,
cisplatin, dactinomycin, temozolomide, and irinotecan.
Trial website
https://clinicaltrials.gov/show/NCT01014767
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Johannes Wolff, MD
Address 0 0
Pending
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

No data has been provided for results reporting
Summary results
Not applicable