Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Choroid Plexus Tumors
Condition: Brain Cancer; Choroid Plexus Tumors
MeSH terms: Brain Neoplasms; Choroid Plexus Neoplasms
Intervention: Carboplatin; Cisplatin; Cyclophosphamide; Dactinomycin; Doxorubicin; Etoposide; Irinotecan; Leucovorin; Methotrexate; Temozolomide; Vincristine
Intervention description: 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; Cycles 1 & 2: 70 mg/m²/d IV over 6 hours on day 4; 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; Cycles 1 & 2: 45 µg/kg/day (max. 2 mg), IV on day 1; Cycles 1 & 2: 25 mg/m²/day IV over 12 hrs on days 1-3; 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; Temozolomide Irinotecan arm (4), Cycles 1 & 2:
50 mg/m2/day x 5 days as 1 hour IV infusions; Given with Methotrexate as leucovorin rescue at hour 42 given three times on days 1, 15 and 29.; 5g/m2 IV over 24 hours with leucovorin rescue at hour 42 given three times on days 1, 15 and 29.; 150 mg/m2/day x 5 days orally and combined with irinotecan 50 mg/m2/day IV x 5 days as one hour infusions.; 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 MeSH terms: Leucovorin; Dactinomycin; Cyclophosphamide; Temozolomide; Cisplatin; Carboplatin; Doxorubicin; Methotrexate; Irinotecan; Etoposide; Vincristine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Healthy volunteers: No
Keywords: Choroid Plexus Tumors; Brain Tumor; Chemotherapy; Etoposide; Carboplatin; Vincristine; Cyclophosphamide; Methotrexate; Doxorubicin; Cisplatin; Dactinomycin; temozolomide; irinotecan; Pediatrics

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.
    

Eligibility criteria:

        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.