Brain CancerPhase 2NCT01105702
Temodar (Temozolomide), Bevacizumab, Lithium and Radiation for High Grade Glioma
A Phase 2 study testing Temozolomide, Bevacizumab and Lithium Carbonate in people with Brain Cancer, run by NYU Langone Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Cancer
- What is being tested?
- Temozolomide, Bevacizumab and Lithium Carbonate
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2010to Apr 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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);
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- 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 nonsteroidal antiinflammatory drugs, antipsychotics, iodides, and angiotensin-converting enzyme inhibitor, 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 degrees Fahrenheit;
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New York University Clinical Cancer Center
New York, New York, 10016
Overlook Hospital
Summit, New Jersey, 07902
About this study
Official title: Temozolomide, Bevacizumab, Lithium and Radiation Treatment for Newly Diagnosed High Grade Glioma: A Phase II Study
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.
Read the detailed description
Treatment of high grade glioma (HGG) with anti-angiogenic therapy results in clinical improvement and prolonged progression-free survival (PFS). However, mant patients experience diffuse recurrence and treatment failure. This is a phase II trial testing the feasibility of adding lithium carbonate, previously shown to have anti-invasive properties in HGG, to bevacizumab and chemoradiation following surgical resection of HGG.
- Conditions
- Brain Cancer
- Being tested
- Temozolomide, Bevacizumab, Lithium Carbonate, Radiation
- Keywords
- brain tumor, brain cancer, glioma
- Medical subject headings
- Brain Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
Also called Temodar
BevacizumabDrug
Also called Avastin
Lithium CarbonateDrug
Also called Lithobid
RadiationRadiation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Temozolomide; Drug: Bevacizumab; Drug: Lithium Carbonate; Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 50 months
Secondary outcomes (2)
Median Overall Survival (OS)
OS defined as time from diagnosis to most recent follow up or death.
Measured: Up to 50 months
Number of Patients With Grade 3 or 4 Adverse Events
Adverse events evaluated per CTCAE 3
Measured: The whole time while on treatment and 30 days after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionApr 2014
- Study completionApr 2015
Why it stopped: Due to slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Atlantic Health System
- Responsible party
- Sponsor
- Investigators
- Deborah Gruber, MD, Principal investigator, New York University Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105702
- Sponsor's protocol ID
- NYU 07-712
- Status last verified
- Jul 2016
- First submitted
- 12 Apr 2010
- Last updated
- 4 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 20231676
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temozolomide, Bevacizumab, Lithium and Radiation Treatment for Newly Diagnosed High Grade Glioma: A Phase II Study
- ClinicalTrials.gov ID
- NCT01105702
- Acronym / sponsor ID
- NYU 07-712
- Conditions
- Brain Cancer
- Keywords
- brain tumor, brain cancer, glioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to slow accrual
- Enrolment
- 28 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Genentech, Inc., Atlantic Health System
- Study start
- May 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 16 Apr 2010 (estimated)
- Results
- Posted 6 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Treatment of high grade glioma (HGG) with anti-angiogenic therapy results in clinical improvement and prolonged progression-free survival (PFS). However, mant patients experience diffuse recurrence and treatment failure. This is a phase II trial testing the feasibility of adding lithium carbonate, previously shown to have anti-invasive properties in HGG, to bevacizumab and chemoradiation following surgical resection of HGG.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TBL/RT | Experimental | Drug: Temozolomide, Drug: Bevacizumab, Drug: Lithium Carbonate, Radiation: RadiationCycle 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- >=18 years of age;
- Karnofsky Performance Score >= 70;
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TemozolomideAlso: Temodar | Drug | TBL/RT |
| BevacizumabAlso: Avastin | Drug | TBL/RT |
| Lithium CarbonateAlso: Lithobid | Drug | TBL/RT |
| Radiation | Radiation | TBL/RT |
Primary outcome
Median Progression-Free Survival (PFS)
Time frame: Up to 50 months
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).
2 secondary outcomes
Median Overall Survival (OS)
Time frame: Up to 50 months
Number of Patients With Grade 3 or 4 Adverse Events
Time frame: The whole time while on treatment and 30 days after the treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20231676Wen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Gruber, MD principal investigator
New York University Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Temozolomide, Bevacizumab and Lithium Carbonate in people with Brain Cancer, run by NYU Langone Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Progression-Free Survival (PFS) (time frame: Up to 50 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01105702, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.