Zactima With Temodar During Radiation Treatment for Newly Diagnosed Stage IV Brain Tumors

Summary

Phase I:

The purpose of this research study is to determine the safety of the combination treatment of ZD6474 (Vandetanib) with the standard therapy for glioblastomas and gliosarcomas, temozolomide (Temodar) and radiation therapy. This agent is investigational for the treatment of glioblastomas. We will determine the highest dose of ZD6474 (Vandetanib) that can be given safely when combined with temozolomide (Temodar) and radiation therapy.

Phase II:

The purpose of this research study is to determine the efficacy of the combination treatment of ZD6474 (Vandetanib) with the standard therapy for glioblastomas and gliosarcomas, temozolomide (Temodar) and radiation therapy. This agent is investigational for the treatment of glioblastomas.

All subjects participating in this research study must NOT be taking a certain type of anti-seizure medication called enzyme inducing anticonvulsant drugs. These drugs include (but are not limited to) the following medications: Dilantin, Tegretol, Phenobarbital and trileptal.

Conditions

• Glioblastoma Multiforme
• Gliosarcoma

Interventions

DRUG

ZD6474

Taken orally once a day (at 100 mg/day is the phase II dose; the MTD determined by the phase I portion of the trial) until disease gets worse or participants experience unacceptable side effects

DRUG

temozolomide

During the 'Induction' phase: 75/mg/m2/day temozolomide will be given orally daily for 6 weeks (42 days) during radiation therapy, beginning either the night before or on the first day of the first fraction of radiation, including weekends and holidays. This is followed by a 4-6 week break. During the 'Maintenance' phase: The first post-radiation temozolomide cycle will be administered at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle. If 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given. This is given for 12 cycles.

RADIATION

Radiation Therapy

Radiotherapy must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy.

Sponsors & Collaborators

• Dana-Farber Cancer Institute

  collaborator OTHER

• Beth Israel Deaconess Medical Center

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• Memorial Sloan Kettering Cancer Center

  collaborator OTHER

• Henry Ford Hospital

  collaborator OTHER

• Patrick Y. Wen, MD

  lead OTHER

Principal Investigators

• Patrick Y Wen, MD · Dana-Farber Cancer Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-05-25

Primary Completion

2013-08-31

Completion

2017-10-10

Countries

• United States

Study Locations