Brain Cancer Clinical Trial
Official title:
CPT-SIOP-2009: Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Patients With Choroid Plexus Tumors
Verified date | August 2019 |
Source | Tufts Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 27 |
Est. completion date | January 2014 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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. 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. |
Country | Name | City | State |
---|---|---|---|
Germany | St. Hedwig Children's Hospital, University of Regensburg (International Study Center) | Regensburg | |
Hungary | Semmelweis University | Budapest | |
New Zealand | Christchurch Hospital | Christchurch | |
United States | Tufts Medical Center | Boston | Massachusetts |
United States | Children's Cancer Hospital at UT MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Tufts Medical Center |
United States, Germany, Hungary, New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Disease Progression | PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available | Till disease progression or death (up to 6 cycles of 28-day treatment) | |
Primary | Toxicity During First 4 Months of Therapy | PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available | 4 Months |
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