Treatment of Tumors of the Choroid Plexus Epithelium
Condition: Choroid Plexus Tumors
MeSH terms: Choroid Plexus Neoplasms
Intervention: Carboplatin; Cyclophosphamide; Etoposide; Vincristine; Radiation Therapy
Intervention description: 350 mg/m^2 by vein, Over 2 Hours x 2 Days; 1 g/m^2 by vein, Over 1 Hour x 2 Days; 100 mg/m^2 by vein, Over 1 Hour x 5 Days; 1.5 mg/m^2 (by vein)IV Push Over 15 Minutes On Day 5; Radiation treatment over a period of about 6 weeks.
Intervention MeSH terms: Cyclophosphamide; Carboplatin; Etoposide; Vincristine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Healthy volunteers: No
Keywords: Choroid Plexus Tumors; Carboplatin; Cyclophosphamide; Etoposide; Vincristine; Paraplatin; Cytoxan; Neosar

Summary:

      The goal of this clinical research study is to compare carboplatin to cyclophosphamide when
      given with etoposide, vincristine, and radiation therapy in the treatment of choroid plexus
      tumors. The safety of these 2 combination therapies will also be compared.

      Objectives:

      OVERALL AIM:

      To improve choroid plexus tumor treatment through better understanding of the tumor biology
      and through increased knowledge about the benefit of specific treatment elements.

      Specific Objectives:

      The study will have a prephase to evaluate the feasibility of the following randomized study
      (main phase).

      Pre-Phase (completed 2005) Primary Specific Objective:

      To determine the number of patients accountable per year for randomization in a worldwide
      study.

      Secondary Specific Objective:

      To measure the number of drop outs and to describe the toxicity of the chemotherapy.

      Main Phase (started in 2006) Primary Specific Objective:

      To compare the survival times after cyclophosphamide based treatment with the survival times
      after carboplatin based treatment in choroid plexus tumor patients.

      Main Phase Secondary Specific Objectives:

        1. To compare the resectability of choroid plexus tumors after two blocks of
           cyclophosphamide based treatment with the resectability after two blocks of carboplatin
           based treatment.

        2. To compare response rates of incompletely resected choroid plexus tumors to two blocks
           of cyclophosphamide based treatment with the response rates after two blocks of
           carboplatin based treatment.

        3. To determine the prognostic relevance of histological atypia and SV40 in choroid plexus
           tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The reference center has confirmed the receipt of slides sent (For randomization only
             = form 2)

          2. The postoperative imaging has been done and the result is available (for randomization
             only = for form 2 only)

          3. Indication criteria: Choroid plexus papilloma (Gr I) with histologically confirmed
             metastases. (For randomization only = use form 2).

          4. Indication criteria: Atypical choroid plexus papilloma or anaplastic choroid plexus
             papilloma histology with either metastases or postoperative residual tumor. (For
             randomization only = use form 2).

          5. Indication criteria: Choroid plexus carcinoma, regardless of histologically confirmed
             metastases or residual tumor. (For randomization only = use form 2).

          6. Informed consent signed (required for registration = form 1, and for randomization =
             form 2)

          7. Patients must have the following: WBC > 2000/ul, platelets >85 000/ul, serum
             creatinine in normal range, pregnancy test negative, hearing loss less than 30dB at
             3000 Hz.

        Exclusion Criteria:

          1. Previous irradiation or chemotherapy. (Exclusion from randomization only)

          2. The protocol did not pass the local centre required approvals, such as the Ethics
             Committee or the scientific review.

          3. Previous immunotherapy or antiangiogenic therapy (Exclusion from randomization only)