Not provided
Not provided
Not provided
Not provided
Not provided
Due to slow accrual
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| Atlantic Health System | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TBL/RT | Experimental | Cycle 1(One 42-day cycle)
Treatment Cycles 2-7 (28 days per cycle)
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temozolomide | Drug |
|
| |
| Bevacizumab |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Median Overall Survival (OS) | OS defined as time from diagnosis to most recent follow up or death. | Up to 50 months |
| Number of Patients With Grade 3 or 4 Adverse Events | Adverse events evaluated per CTCAE 3 |
Not provided
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:
>=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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Deborah Gruber, MD | New York University Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Overlook Hospital | Summit | New Jersey | 07902 | United States | ||
| New York University Clinical Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20231676 | Background | 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. |
Not provided
Not provided
Not provided
From June 2010 to June 2012, 28 patients were enrolled from New York University Langone Medical Center and Outlook Hospital, Summit, NJ.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | TBL/RT | Cycle 1(One 42-day cycle)
Treatment Cycles 2-7 (28 days per cycle)
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All patients enrolled
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TBL/RT | Cycle 1(One 42-day cycle)
Treatment Cycles 2-7 (28 days per cycle)
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Intent-to-treat population | Posted | Median | 95% Confidence Interval | months | Up to 50 months |
|
whole time while on treatment plus 30 days after the treatment
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TBL/RT | Cycle 1(One 42-day cycle)
Treatment Cycles 2-7 (28 days per cycle)
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection with unknown ANC: Wound | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip): | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Gruber, MD | Perlmutter Cancer Center at NYU Langone | 212-731-5577 | michael.gruber@nyumc.org |
Not provided
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| D000068258 | Bevacizumab |
| D016651 | Lithium Carbonate |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
|
| Lithium Carbonate | Drug |
|
|
| Radiation | Radiation |
|
| The whole time while on treatment and 30 days after the treatment |
| New York |
| New York |
| 10016 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| World Health Organization Grade (staging) | Grade III: Malignant although there is not always a big difference between grade II and grade III tumors. The cells of a grade III tumor are actively reproducing abnormal cells, which grow into nearby normal brain tissue. These tumors tend to recur, often as a grade IV. Grade IV: These are the most malignant tumors. They reproduce rapidly, can have a bizarre appearance when viewed under the microscope, and easily grow into nearby normal brain tissue. These tumors form new blood vessels so they can maintain their rapid growth. | Number | participants |
|
|
|
| Secondary | Median Overall Survival (OS) | OS defined as time from diagnosis to most recent follow up or death. | intent-to-treat population | Posted | Median | 95% Confidence Interval | months | Up to 50 months |
|
|
|
| Secondary | Number of Patients With Grade 3 or 4 Adverse Events | Adverse events evaluated per CTCAE 3 | all the patients with treatment | Posted | Number | participants | The whole time while on treatment and 30 days after the treatment |
|
|
|
| 7 |
| 28 |
| 26 |
| 28 |
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection with unknown ANC: Lung (pneumonia) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy: sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection with unknown ANC: Eye NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Pain - Other (Specify, __): jaw | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Seizure | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
|
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ataxia (incoordination) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Auditory/Ear - Other (Specify, __): flud in right ear | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Calcium, serum-high (hypercalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cholesterol, serum-high (hypercholestremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Confusion | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dental: periodontal disease | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema: limb | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Flushing | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hearing: patients without baseline audiogram and not enrolled in a monitoring program | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Heartburn/dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage, GI: Oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage, GI: Rectum | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage, pulmonary/upper respiratory: Nose | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection - Other (Specify, __): thrush | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection - Other (Specify, __): Urinary tract infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils: Urinary tract NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mood alteration: Anxiety | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mood alteration: Depression | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mucositis/stomatitis (clinical exam): Stomach | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muscle weakness, generalized or specific area (not due to neuropathy): Whole body/generalized | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nasal cavity/paranasal sinus reactions | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy: cranial- Pupil, upper eyelid, extra ocular movements | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy: cranial- sensory facial | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy: Cranial-smell | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy: sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nystagmus | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain: Back | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain: Bone | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain: Chest/thorax NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain: Dental/teeth/peridontal | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain: Extremity-limb | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain: Head/headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain: Middle ear | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain: Stomach | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Psychosis (hallucinations/delusions) | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash: dermatitis associated with radiation: Chemoradiation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Seizure | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Somnolence/depressed level of consciousness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Speech impairment (e.g., dysphasia or aphasia) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Supraventricular and nodal arrhythmia: Sinus bradycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sweating (diaphoresis) | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Syncope (fainting) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Taste alteration (dysgeusia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thyroid function, high (hyperthyroidism, thyrotoxicosis) | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urinary frequency/urgency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urinary retention (including neurogenic bladder) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vision-blurred vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vision-flashing lights/floaters | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weight loss: | General disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002254 | Carbonates |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D018020 | Lithium Compounds |
| D055585 | Physical Phenomena |
| Neurologic |
|
| Pneumonia |
|
| Rash |
|
| Cough |
|
| Hyponatremia |
|
| Gastrointestinal |
|
| Febril Neutropenia |
|
| Neutropenia |
|
| Thrombocytopenia |
|
| Somnolence |
|