Clinical Trial: Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Choroid Plexus Tumors

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

Official Title: CPT-SIOP-2009: Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Patients With Choroid Plexus Tumors

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.

Detailed Summary:

Tissue Banking:

If you agree, samples of your leftover tissue (left over from standard care procedures) will be stored in a research tissue bank by SIOP for use in future research related to cancer.

Data Collection:

If you agree, data from your medical record will be sent to SIOP. The data will be stored in secure research databases by SIOP for use in future research related to cancer. One planned use of the databases is to learn how many patients have choroid plexus tumors, what type of choroid plexus tumors patients have, and the results of treatment for different types of choroid plexus tumors.

Other Information:

Before your tissue and/or data is sent to SIOP for storage, your name and any personal identifying information will be coded to protect your privacy. SIOP will not have access to the codes that link the data to your identity. Tufts Medical CEnter will not have oversight of any leftover tissue and/or data that will be stored by SIOP for additional research.

Length of Study:

You will be on-study for as long as you agree to continue having your tissue and/or data used for research.

This is an investigational study. Up to 190 patients will take part in this study. Up to 6 will be enrolled at M. D. Anderson.

Clinical Research:

The Study Drugs:

The study drugs are all designed to interfere with the growth of cancer cells by blocking cell division, which may cause the cells to
Sponsor: Tufts Medical Center

Current Primary Outcome:

  • Time to Disease Progression [ Time Frame: Till disease progression or death (up to 6 cycles of 28-day treatment) ]
  • Toxicity during first 4 months of therapy [ Time Frame: 4 Months ]


Original Primary Outcome:

  • Time to Disease Progression [ Time Frame: Baseline to disease progression or death (up to 6 cycles of 28-day treatment) ]
  • Toxicity during first 4 months of therapy [ Time Frame: Baseline to 4 Months ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Tufts Medical Center

Dates:
Date Received: November 13, 2009
Date Started: November 2009
Date Completion:
Last Updated: July 21, 2016
Last Verified: July 2016