Temodar (Temozolomide), Bevacizumab, Lithium and Radiation for High Grade Glioma
Information source: New York University School of Medicine
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain Cancer
Intervention: Temozolomide, bevacizumab, lithium, radiation (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: New York University School of Medicine Official(s) and/or principal investigator(s):
Michael Gruber, MD, Principal Investigator, Affiliation: New York University Clinical Cancer Center
Overall contact:
Donna Catamero, RN, Phone: 212-731-5404, Email: donna.catamero@nyumc.org
Summary
This is an open-label, Phase II study to estimate the effect on time to tumor progression
and safety in patients with newly diagnosed high grade glioma.
Clinical Details
Official title: Temozolomide, Bevacizumab, Lithium and Radiation Treatment for Newly Diagnosed High Grade Glioma: A Phase II Study
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Time to Tumor Progression
Detailed description:
Cycle 1 (42-day cycle):
Temozolomide will be taken at a dose of 75 mg/m2 orally, beginning the night prior to the
first radiation treatment. Duration of temozolomide treatment is 42 consecutive days.
Radiation therapy must begin within 3 weeks of surgery. Treatment of 1. 8 Gy will be given
daily for 5 days per week, Monday through Friday. Treatment will continue for 33 fractions
for a total dose of 59. 4 Gy over 6. 5 weeks. All portals shall be treated during each
treatment session. Doses are specified as the target dose that shall be to the center of
the target volume.
Bevacizumab will be added to the temozolomide/radiation treatment plan 29(+3 if necessary)
days post surgery . This may be delayed to ensure that 28 days has elapsed between surgery
and the first dose of bevacizumab. No patient will be treated with bevacizumab before 28
days after a surgical procedure.
Bevacizumab treatment continues until the first post-treatment MRI is performed.
Radiological re-evaluation by MRI with gadolinium contrast with perfusion sequences will be
performed at 35 days (+ 2 days) after completion of radiation therapy. Assessment of
response will continue to be performed following every 2 cycles.
Treatment Cycle 2-7 (28 day cycles):
If the Cycle 1 post-treatment MRI is stable or without sign of recurrent tumor the
subsequent cycles (Cycles 2 - 7) will be administered as follows:
- Temozolomide at a dose of 150 mg/m2 will be taken orally on Days 1-7
- Bevacizumab will be administered at a dose of 10 mg/kg per dosing administration on Day
8 and Day 22
- Magnetic Resonance Imaging is performed after every 2 cycles
Lithium Carbonate: Initiate treatment at 300 mg PO BID; increase dose every 7 days by 300 mg
to goal total dose of 1200 mg per day. Serum levels will than be assessed and dose adjusted
until therapeutic level of 0. 8 to 1. 2 mEq/L is reached. Adjust dose according to clinical
response and trough serum level (12 h) after steady state is reached (4-5 days).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Newly diagnosed high grade glioma (WHO Grade III and IV)
- Brain magnetic resonance imaging (MRI) scan with gadolinium contrast
- If taking an AED, must be Keppra, or Lamictal or Depakote
- Must have normal organ and marrow function
- Negative Pregnancy Test for women of childbearing potential
- Residual measurable disease.
Exclusion Criteria:
- Current, recent (within 4 weeks of the first infusion of this study), or planned
participation in an experimental drug study
- Prior radiation therapy to the brain
- Prior treatment with Chemotherapy or Targeted agent
- Previous (within last 5 years) or current malignancies at other sites except for
adequately treated basal cell or squamous cell skin cancer in situ carcinoma of the
cervix
- Uncontrolled High blood pressure
- History of myocardial infarction within 6 months
- History of stroke within 6 months
- Clinically significant peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to the first dose of bevacizumab or anticipation of need for major surgical
procedure during the course of the study
- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days
prior to study enrollment
- Serious, non-healing wound, ulcer, or bone fracture
- Glioma showing prior spontaneous hemorrhage
- Patients on enzyme-inducing anti-epileptic drugs
- Known Positive HIV-1, hepatitis B surface antigen, or hepatitis C antibody
- Any previous cytotoxic drug therapies, excluding corticosteroids and temozolomide
concurrent with radiation therapy
- Any known genetic cancer-susceptibility syndromes;
- Acute infection: any active viral, bacterial, or fungal infection that requires
specific therapy. Antibiotic therapy must have been completed at least 7 days prior
to first immunization
- Active uncontrolled infection - examples include sexually transmitted disease,
herpes, scrofula, malaria, etc.
- Fever over 101. 5
- Unstable or severe intercurrent medical conditions such as unstable angina,
uncontrolled arrythmias, Crohn's disease, ulcerative colitis, psoriasis, etc.
- Implantation of Gliadel wafers at surgery
- Organ allografts
- Allergies to reagents used in this study
Locations and Contacts
Donna Catamero, RN, Phone: 212-731-5404, Email: donna.catamero@nyumc.org
New York University Clinical Cancer Center, New York, New York 10016, United States
Additional Information
Starting date: April 2010
Last updated: April 15, 2010
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