Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Choroid Plexus Tumors

• Status: Terminated
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tufts Medical Center
• Treatments: Camptothecin; Carboplatin; Cisplatin; Cyclophosphamide; Dacarbazine; Dactinomycin; Doxorubicin; Etoposide; Etoposide phosphate; Irinotecan; Leucovorin; Liposomal doxorubicin; Methotrexate; Temozolomide; Vincristine

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.