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

NCT01105702 | Terminated Phase 2 Results DMC

• 1 other identifier: NYU 07-712
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

This pilot phase II trial studies how well giving temozolomide, bevacizumab, lithium carbonate, and radiation therapy works in treating patients with newly diagnosed high grade glioma.

Conditions

Brain Cancer

Keywords

brain tumor; brain cancer; glioma

Outcome Measures

Primary Outcomes (1)

• Median Progression-Free Survival (PFS)

  PFS defined as time from date of diagnosis to most recent follow up, disease progression, or death. Disease progress defined as either clinical deterioration or radiographic progressive disease on magnetic resonance imaging (MRI) per updated response assessment in neuro-oncology criteria (Wen, et al).

  Up to 50 months

Secondary Outcomes (2)

• Median Overall Survival (OS)

  Up to 50 months

• Number of Patients With Grade 3 or 4 Adverse Events

  The whole time while on treatment and 30 days after the treatment

Study Arms (1)

TBL/RT

EXPERIMENTAL

Cycle 1(One 42-day cycle) * Temozolomide 75 mg/m\^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment * Radiation within 3-5 weeks of surgery * Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks Treatment Cycles 2-7 (28 days per cycle) * Temozolomide at a dose of 150 mg/m\^2 on Days 1-7 * Bevacizumab 10 mg/kg on Day 8 and Day 22 * Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L.

Drug: Temozolomide; Drug: Bevacizumab; Drug: Lithium Carbonate; Radiation: Radiation

Interventions

Temozolomide DRUG

Also known as: Temodar

TBL/RT

Bevacizumab DRUG

Also known as: Avastin

TBL/RT

Lithium Carbonate DRUG

Also known as: Lithobid

TBL/RT

Radiation RADIATION

TBL/RT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• NYU Langone Health: lead
• Genentech, Inc.: collaborator
• Atlantic Health System: collaborator

Study Sites (2)

Overlook Hospital

Summit, New Jersey, 07902, United States

Location

New York University Clinical Cancer Center

New York, New York, 10016, United States

Location

Related Publications (1)

• Wen PY, Macdonald DR, Reardon DA, Cloughesy TF, Sorensen AG, Galanis E, Degroot J, Wick W, Gilbert MR, Lassman AB, Tsien C, Mikkelsen T, Wong ET, Chamberlain MC, Stupp R, Lamborn KR, Vogelbaum MA, van den Bent MJ, Chang SM. Updated response assessment criteria for high-grade gliomas: response assessment in neuro-oncology working group. J Clin Oncol. 2010 Apr 10;28(11):1963-72. doi: 10.1200/JCO.2009.26.3541. Epub 2010 Mar 15.

  PMID: 20231676 BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms; Glioma

Interventions

Temozolomide; Bevacizumab; Lithium Carbonate; Radiation

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Carbonates; Alkalies; Inorganic Chemicals; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds; Physical Phenomena

Results Point of Contact

• Title: Michael Gruber, MD
• Organization: Perlmutter Cancer Center at NYU Langone

michael.gruber@nyumc.org

212-731-5577

Study Officials

• Deborah Gruber, MD

  New York University Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: April 16, 2010
• Study Start: May 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2015
• Last Updated: August 4, 2016
• Results First Posted: November 6, 2015

Record last verified: 2016-07

Locations

US (2)