Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Choroid Plexus Tumors

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.

Conditions

• Brain Cancer
• Choroid Plexus Tumors

Interventions

DRUG

Carboplatin

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

DRUG

Cisplatin

Cycles 1 \& 2: 70 mg/m²/d IV over 6 hours on day 4

DRUG

Cyclophosphamide

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

DRUG

Dactinomycin

Cycles 1 \& 2: 45 µg/kg/day (max. 2 mg), IV on day 1

DRUG

Doxorubicin

Cycles 1 \& 2: 25 mg/m²/day IV over 12 hrs on days 1-3

DRUG

Etoposide

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

DRUG

Irinotecan

Temozolomide Irinotecan arm (4), Cycles 1 \& 2: 50 mg/m2/day x 5 days as 1 hour IV infusions

DRUG

Leucovorin

Given with Methotrexate as leucovorin rescue at hour 42 given three times on days 1, 15 and 29.

DRUG

Methotrexate

5g/m2 IV over 24 hours with leucovorin rescue at hour 42 given three times on days 1, 15 and 29.

DRUG

Temozolomide

150 mg/m2/day x 5 days orally and combined with irinotecan 50 mg/m2/day IV x 5 days as one hour infusions.

DRUG

Vincristine

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

Sponsors & Collaborators

• Tufts Medical Center

  lead OTHER

Principal Investigators

• Johannes Wolff, MD · Pending

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-11-30

Primary Completion

2013-10-31

Completion

2014-01-31

FDA Drug

Yes

Countries

• United States
• Germany
• Hungary
• New Zealand

Study Locations