Zactima With Temodar During Radiation Treatment for Newly Diagnosed Stage IV Brain Tumors
Information source: Dana-Farber Cancer Institute
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glioblastoma Multiforme; Gliosarcoma
Intervention: ZD6474 (Drug); temozolomide (Drug); Radiation Therapy (Radiation)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: Dana-Farber Cancer Institute Official(s) and/or principal investigator(s):
Patrick Y Wen, MD, Principal Investigator, Affiliation: Dana-Farber Cancer Institute
Overall contact:
Patrick Y Wen, MD, Phone: 617-632-2166, Email: pwen@partners.org
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
the following medications: Dilantin, Tegretol, Phenobarbital and trileptal.
Clinical Details
Official title: Phase I/II Study of ZD6474 (Vandetanib) With Radiation Therapy and Concomitant and Adjuvant Temozolomide in Patients With Newly-Diagnosed Glioblastoma
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Primary outcome: PHASE I: To determine the maximum tolerated dose of ZD6474 (Vandetanib) in patients with newly-diagnosed glioblastomas multiforme (GBM) and gliosarcomas who are also receiving radiation therapy with concomitant and adjuvant temozolomide.PHASE II: To determine the efficacy of ZD6474 (Vandetanib) in combination with radiation therapy and concomitant and adjuvant temozolomide in patients with newly-diagnosed GBM and gliosarcomas as measured by overall survival and median survival.
Secondary outcome: PHASE II: To determine the 12-month survival and median time to tumor progression.PHASE II: To further evaluate the safety profile of ZD6474 (Vandetanib) in combination with radiation therapy and temozolomide in this patient population. PHASE I: To define the safety of ZD6474 (Vandetanib) with radiation therapy and concomitant and adjuvant temozolomide in this population.
Detailed description:
Currently the standard treatment for glioblastomas and gliosarcomas is temozolomide
(Temodar) and radiation therapy. This study is being done because research has shown that
glioblastomas have genetic changes that may cause an excess of certain cell growth factors
and their receptors, which can cause uncontrolled tumor growth. The drug being used in this
research study, ZD6474 (Vandetanib), is designed to block the receptors to two of these
growth factors, the vascular endothelial growth factor (VEGF) and the epidermal growth
factor (EGF). These growth factors are important in pathways that promote tumor growth and
increasing blood supply to the tumor. Blocking these receptors may reduce the blood supply
to the tumor and help slow down tumor growth. There is also laboratory evidence that
blocking these receptors may increase the sensitivity of glioblastomas to radiation therapy.
This research study is a Phase I/II clinical trial.
Phase I clinical trials test the safety of an investigational drug. Phase I studies also
try to define the appropriate dose of the investigational drug to use for further studies.
We will determine the highest dose of ZD6474 (Vandetanib) that can be given safely when
combined with temozolomide (Temodar) and radiation therapy.
The purpose of Phase II 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. It will look to see how
patients are do on treatment (if they progress and when, how they are doing after 12 months
of treatment). In this research study, the safety of the combination treatment of ZD6474
(Vandetanib) with the standard therapy for glioblastomas and gliosarcomas, temozolomide
(Temodar) and radiation therapy will be further evaluated. We will also be looking at
samples to see if there are correlations between them and how well patients do on treatment.
This agent is investigational for the treatment of glioblastomas. "Investigational" means
that the drug is still being studied and that research doctors are trying to find out more
about it. It also means that the FDA (U. S. Food and Drug Administration) has not approved
ZD6474 (Vandetanib) for use for your type of cancer. 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 the following medications: Dilantin,
Tegretol, Phenobarbital and trileptal.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
All inclusion and exclusion criteria apply to both phase I and II patients.
Inclusion Criteria:
- Subjects with histologically proven intracranial glioblastoma multiforme (GBM) and
gliosarcoma will be eligible for this protocol.
- Diagnosis will have been established by biopsy or resection no more than 4 weeks (28
days) prior to registration.
- Gadolinium MRI or contrast CT must be obtained within 14 days prior to registration.
- Subjects must have a plan to begin treatment with ZD6474 (vandetanib) and/or
temozolomide no sooner than 3 weeks (21 days) after surgical resection or biopsy.
- Subjects must have a plan to begin partial brain radiotherapy 5-7 days after
beginning ZD6474. Radiotherapy must be a) at the Radiation Oncology Department of
the participating institution, or b) at an affiliated site that is currently approved
to participate in any trial of the Radiation Therapy Oncology Group (RTOG).
- Subjects must be willing to forego other cytotoxic and non-cytotoxic drug therapy
against the tumor while being treated with ZD6474 (ZactimaTM), with the exception of
temozolomide.
- All subjects must sign an informed consent indicating that they are aware of the
investigational nature of this study.
- Subjects must be > 18 years old.
- Subjects must be able to care for themselves.
- Women of childbearing potential must have a negative pregnancy test documented within
14 days prior to registration.
- Men and women of childbearing potential must agree to use adequate contraception.
Exclusion Criteria:
- Subjects must not have had prior cranial radiation therapy.
- Subjects must not have had prior treatment for brain tumors.
- Subjects must not have received prior Gliadel wafers.
- Subjects must not have any significant medical illnesses.
- Subjects with a history of any other cancer (except non-melanoma skin cancer or
carcinoma in-situ of the cervix), unless in complete remission and off of all therapy
for that disease for a minimum of 3 years are ineligible.
- Subjects must not have any unresolved toxicity greater than CTC grade 1 related to
previous anti-cancer therapy.
- Subjects must not have active infection.
- Subjects must not be pregnant/breast feeding.
- Subjects must not have history of any clinically significant cardiac event, or
evidence of heart disease.
- Subjects must not have any enzyme-inducing anti-epileptic drugs (Dilantin, Tegretol,
valproic acid, trileptal.
- Subjects must not have uncontrolled high blood pressure.
- Subjects must not have active diarrhea that may affect the ability of the patient to
absorb or tolerate ZD6474 (ZactimaTM).
Locations and Contacts
Patrick Y Wen, MD, Phone: 617-632-2166, Email: pwen@partners.org
Dana Farber / Brigham and Women's Cancer Center, Boston, Massachusetts 02115, United States; Recruiting
Lisa Doherty, ANP, Phone: 617-632-5925, Email: lisa_doherty@dfci.harvard.edu
Debra C LaFrankie, RN, OCN, Phone: 617-632-6327, Email: debra_lafrankie@dfci.harvard.edu
Patrick Wen, MD, Principal Investigator
Jan Drappatz, MD, Sub-Investigator
Santosh Kesari, MD, Sub-Investigator
Andrew Norden, MD, Sub-Investigator
Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Tracy T Batchelor, MD, Phone: 617-724-8770, Email: tbatchelor@partners.org
Nancy Shearer, RN, Phone: 617-726-7851, Email: nshearer@partners.org
Tracy T Batchelor, MD, Sub-Investigator
Scott Plotkin, MD, Sub-Investigator
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States; Recruiting
Eric T Wong, MD, Phone: 617-667-1665, Email: ewong@bidmc.harvard.edu
Loretta Barron, NP, Phone: 617-667-1665, Email: lbarron@bidmc.harvard.edu
Suriya Jeyapalan, MD, Sub-Investigator
Henry Ford Hospital, Detroit, Michigan 48202, United States; Not yet recruiting
Tiffany Pearce, Phone: 313-916-1784, Email: TPEARCE1@hfhs.org
Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States; Not yet recruiting
Andrew Lassman, MD, Phone: 212-639-6037, Email: lassman@mskcc.org
Kristin Herman, Phone: 646-227-2269, Email: hermank@mskcc.org
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania 15232-1305, United States; Not yet recruiting
Frank Lieberman, MD, Phone: 412-692-2600, Email: liebermanf@msx.upmc.edu
University of Virginia, Charlottesville, Virginia 22908-4324, United States; Active, not recruiting
Additional Information
Starting date: May 2007
Ending date: May 2010
Last updated: March 10, 2009
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