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Temodar (Temozolomide), Bevacizumab, Lithium and Radiation for High Grade Glioma

Information source: New York University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Brain Cancer

Intervention: Temozolomide (Drug); Bevacizumab (Drug); Lithium (Drug); Radiation (Radiation)

Phase: Phase 2

Status: Terminated

Sponsored by: New York University School of Medicine

Official(s) and/or principal investigator(s):
Deborah Gruber, MD, Principal Investigator, Affiliation: New York University Cancer Institute

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/m^2 orally, beginning the night prior to the first radiation treatment. Duration of temozolomide treatment is 42 consecutive days. Radiation therapy must begin within 3-5 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/m^2 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

- Patient must have normal organ and marrow function as defined below:

- Absolute neutrophil count >= 1,500/mm^3;

- Platelet count >=100,000/mm^3;

- Hemoglobin >= 10g/dL;

- Blood urea nitrogen and serum creatinine both =< 1. 5 times upper limit of normal

(ULN);

- Total bilirubin both =< 1. 5 times ULN;

- SGOT and SGPT both =< 3 times ULN;

- Alkaline phosphatase =< 2 times ULN.

- >=18 years of age;

- Karnofsky Performance Score >= 70;

- Life expectancy >= 8 weeks;

- Negative serum or urine beta-hCG pregnancy test at screening for patients of child

bearing potential;

- Men and women with reproductive potential must agree to use an acceptable method of

birth control (surgical, hormonal or double barrier, ie, condom and diaphragm) during treatment and for 6 months after completion of treatment;

- Patient or their legal proxy must provide written informed consent prior to

registration on study;

- 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 >150/100

- Common Terminology Criteria Adverse Event 3. 0 >= Grade 2 congestive heart failure

(CHF);

- 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;

- Urine protein/Creatinine ratio >= 2. 0 at screening;

- Serious, non-healing wound, ulcer, or bone fracture;

- Inability to comply with study and/or follow-up procedures;

- Glioma showing active intratumoral bleeding;

- Patients on enzyme-inducing anti-epileptic drugs;

- Known Positive HIV-1, hepatitis B surface antigen, or hepatitis C antibody;

- Medications like NSAIDs, antipsychotics, iodides, and ACEI, If they are receiving

them, they must have been discontinued for 7 days prior to initiating lithium;

- 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.

- Active uncontrolled infection - examples include sexually transmitted disease,

herpes, scrofula, malaria, etc.;

- Fever > 101. 5 F0;

- 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;

- Patients with organ allografts; and

- Allergies to reagents used in this study.

Locations and Contacts

Overlook Hospital, Summit, New Jersey 07902, United States

New York University Clinical Cancer Center, New York, New York 10016, United States

Additional Information

Starting date: May 2010
Last updated: January 23, 2015

Page last updated: August 23, 2015

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