Microtubule-Targeted Agent BAL101553 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma

Description

This phase I trial studies the side effects and best dose of microtubule-targeted agent BAL101553 when given together with radiation therapy in treating patients with newly diagnosed glioblastoma. Drugs used in chemotherapy, such as microtubule-targeted agent BAL101553, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving microtubule-targeted agent BAL101553 and radiation therapy may work better in treating patients with glioblastoma.

Study Start Date

June, 07 2017

Estimated Completion Date

July 2021

Interventions

  • Other: Laboratory Biomarker Analysis
  • Radiation: Radiation Therapy
  • Drug: Microtubule-Targeted Agent BAL101553
  • Other: Pharmacological Study

Study ID

Sidney Kimmel Comprehensive Cancer Center -- ABTC 1601

Status

Recruiting

Trial ID

NCT03250299

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

30

Sponsor

Sidney Kimmel Comprehensive Cancer Center

Inclusion Criteria

  • Patients must have histologically-proven GBM
  • Patients must have recovered from the immediate post-operative period
  • Patients must have tumor MGMT methylation status of unmethylated as determined by local pathologist using a Clinical Laboratory Improvement Act (CLIA)-approved diagnostic test
  • results of routinely-used methods for MGMT methylation testing (e.g. methylation-specific [MS]
  • polymerase chain reaction [PCR] or quantitative PCR) are acceptable
  • Patients must be able to undergo magnetic resonance imaging (MRI) of the brain with gadolinium
  • Patients must not have received prior radiation therapy (RT), chemotherapy, immunotherapy or therapy with a biologic agent (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocytes, lymphokine-activated killer cells, or gene therapy), or hormonal therapy for their brain tumor
  • glucocorticoid therapy is allowed
  • Patients must have a tumor tissue form indicating availability of archived tissue from initial resection at diagnosis of GBM, completed and signed by a pathologist
  • Patients must have a Karnofsky performance status >= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Hemoglobin >= 9 g/dL
  • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), unless the patient has known Gilbert's syndrome
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN
  • Creatinine =< 1.5 x ULN
  • Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels > ULN
  • Activated partial thromboplastin time (APTT)/partial thromboplastin time (PTT) =< 1.5 x ULN
  • Sodium >= 130 mmol/L
  • Patients must be able to provide written informed consent
  • Patients must have baseline MRI performed within the 21 days prior to starting treatment
  • Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to treatment start and are required to agree to have the test repeated within 72 hours prior to the first dose of BAL101553
  • women of childbearing potential and men must agree to use highly-effective contraceptive methods for the duration of study participation and for an additional 90 days after the last dose of study drug highly-effective contraceptive methods include male or female sterilization (bilateral tubal occlusion or vasectomy) intrauterine device (IUD) combined (estrogen
  • and progesterone-containing) hormonal contraception (oral, vaginal ring or transdermal patch) with an ethinylestradiol dose of at least 30 ug, plus use of male condoms (preferably with spermicides), female condoms, a female diaphragm or a cervical cap
  • or total sexual abstinence should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately male patients must agree not to donate sperm from the first dose of study drug until 90 days after the end of treatment male patients, without a vasectomy and with a partner of childbearing potential, must agree to use condoms during the study and for at least 90 days after the end of treatment the patient should be instructed that their female partner should use another form of contraception for the duration of the study and continue this use for at least 90 days after the last dose of study drug
  • Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder
  • patients with prior malignancies must be disease-free for >= 5 years
  • Patients must be maintained on a stable corticosteroid regimen (no increase for 5 days) prior to the start of treatment
  • Patients must be able to swallow whole capsules

Exclusion Criteria

  • Patients receiving any other investigational agents are ineligible
  • Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to BAL101553 are ineligible
  • Patients on drugs that are strong inhibitors and/or inducers of CYP2C9, CYP2C19 or CYP3A4 (including enzyme-inducing anti-epileptic drugs [EIAEDs]), are not eligible for treatment under this protocol
  • patients taking non-EIAEDs are permitted to take part in the study patients previously treated with any of the prohibited concomitant medications listed above may be enrolled if they have been off of the medication for >= 10 days prior to the first dose of BAL101553
  • Patients may not be on coumarin anti-coagulants (warfarin, etc.)
  • heparin, low-molecular weight heparin (LMWH), or other antithrombotic medications are permitted
  • Patients with gastrointestinal disease, or those who have had a procedure that is expected to interfere with the oral absorption or tolerance of BAL101553 (e.g., functionally-relevant gastrointestinal obstruction, or frequent vomiting unresolved upon anti-emetic supportive care), are ineligible
  • Patients with peripheral neuropathy >= Common Terminology Criteria for Adverse Events (CTCAE) grade 2 are ineligible
  • Patients with ataxia >= CTCAE grade 2 are ineligible
  • Patients with known acute or chronic hepatitis B or hepatitis C infection are ineligible
  • Patients with systolic blood pressure (SBP) >= 140 mmHg or diastolic blood pressure (DBP) >= 90 mmHg at the screening visit are ineligible
  • patients with an initial clinic blood pressure (BP) >= 140/90 mmHg may be included if SBP < 140 mmHg and DBP < 90 mmHg is confirmed in two subsequent BP measurements on the same day
  • Patients with blood pressure (BP) combination treatment with more than two antihypertensive medications are ineligible
  • Significant cardiac disease or abnormality, including any one of the following:
  • Left ventricular ejection fraction < 50% at screening (assessed by echocardiography, cardiac MRI or multigated acquisition [MUGA])
  • Corrected QT Fridericia's correction formula (QTcF) > 470 ms on screening electrocardiogram (ECG), or a clinically-relevant ECG abnormality
  • Congenital long QT syndrome
  • History of sustained ventricular tachycardia, ventricular fibrillation, or torsades de pointes
  • Presence of atrial fibrillation with tachyarrhythmia (ventricular response rate > 100 beats per minute [bpm])
  • Bradycardia (heart rate < 50 bpm)
  • Complete left bundle branch block.
  • Bifascicular block (complete right bundle branch block and anterior or posterior left hemiblock)
  • Myocardial infarction, acute coronary syndrome (including unstable angina), coronary revascularization procedures, or coronary arterial bypass grafting within the 6 months prior to starting study drug
  • Cardiac troponin (either troponin T or troponin I) > ULN
  • Congestive heart failure of New York Heart Association class III or IV
  • Unstable angina pectoris
  • Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible
  • Pregnant women are excluded from this study
  • breastfeeding should be discontinued if the mother is treated with BAL101553
  • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (32)

Study Location Distance Name Phone Email
DanaFarberHarvard Cancer Center at Dana Farber Cancer Institute - Boston, Massachusetts 2.6 miles Clinical Trials Office DanaFarberHarvard Cancer Center 617-632-2166 None
DanaFarberHarvard Cancer Center at Dana Farber Cancer Institute - Boston, Massachusetts 2.6 miles Clinical Trials Office DanaFarberHarvard Cancer Center 617-632-2166 None
DanaFarberHarvard Cancer Center at Dana Farber Cancer Institute - Boston, Massachusetts 2.6 miles Clinical Trials Office DanaFarberHarvard Cancer Center 617-632-2166 None
DanaFarberHarvard Cancer Center at Dana Farber Cancer Institute - Boston, Massachusetts 2.6 miles Clinical Trials Office DanaFarberHarvard Cancer Center 617-632-2166 None
DanaFarberHarvard Cancer Center at Dana Farber Cancer Institute - Boston, Massachusetts 2.6 miles Clinical Trials Office DanaFarberHarvard Cancer Center 617-632-2166 None
Memorial SloanKettering Cancer Center - New York, New York 184.8 miles Tom Kaley MD 212-639-5122 None
Memorial SloanKettering Cancer Center - New York, New York 184.8 miles Tom Kaley MD 212-639-5122 None
Memorial SloanKettering Cancer Center - New York, New York 184.8 miles Tom Kaley MD 212-639-5122 None
Memorial SloanKettering Cancer Center - New York, New York 184.8 miles Tom Kaley MD 212-639-5122 None
Memorial SloanKettering Cancer Center - New York, New York 184.8 miles Tom Kaley MD 212-639-5122 None
Abrams Cancer Center of the University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Timothy Prior 215-615-3673 NCRD-BTC@uphs.upenn.edu
Johns Hopkins University - Baltimore, Maryland 356.4 miles Matthias Holdhoff MD 410-955-3657 mholdho1@jhmi.edu
Johns Hopkins University - Baltimore, Maryland 356.4 miles Matthias Holdhoff MD 410-955-3657 mholdho1@jhmi.edu
Johns Hopkins University - Baltimore, Maryland 356.4 miles Matthias Holdhoff MD 410-955-3657 mholdho1@jhmi.edu
Johns Hopkins University - Baltimore, Maryland 356.4 miles Matthias Holdhoff MD 410-955-3657 mholdho1@jhmi.edu
Johns Hopkins University - Baltimore, Maryland 356.4 miles Matthias Holdhoff MD 410-955-3657 mholdho1@jhmi.edu
Hillman Cancer Center at University of Pittsburgh Cancer Institute - Pittsburgh, Pennsylvania 477.2 miles Clinical Trials Office UPMC Cancer Centers 412-647-8073 None
Hillman Cancer Center at University of Pittsburgh Cancer Institute - Pittsburgh, Pennsylvania 477.2 miles Clinical Trials Office UPMC Cancer Centers 412-647-8073 None
Hillman Cancer Center at University of Pittsburgh Cancer Institute - Pittsburgh, Pennsylvania 477.2 miles Clinical Trials Office UPMC Cancer Centers 412-647-8073 None
Hillman Cancer Center at University of Pittsburgh Cancer Institute - Pittsburgh, Pennsylvania 477.2 miles Clinical Trials Office UPMC Cancer Centers 412-647-8073 None
Hillman Cancer Center at University of Pittsburgh Cancer Institute - Pittsburgh, Pennsylvania 477.2 miles Clinical Trials Office UPMC Cancer Centers 412-647-8073 None
Cleveland Clinic Taussig Cancer Center - Cleveland, Ohio 544.9 miles Cancer CenterCares 216-444-7923 None
Cleveland Clinic Taussig Cancer Center - Cleveland, Ohio 544.9 miles Cancer CenterCares 216-444-7923 None
Cleveland Clinic Taussig Cancer Center - Cleveland, Ohio 544.9 miles Cancer CenterCares 216-444-7923 None
Cleveland Clinic Taussig Cancer Center - Cleveland, Ohio 544.9 miles Cancer CenterCares 216-444-7923 None
Cleveland Clinic Taussig Cancer Center - Cleveland, Ohio 544.9 miles Cancer CenterCares 216-444-7923 None
Henry Ford Hospital - Detroit, Michigan 612.3 miles Amy Williamson RN None awillia12@hfhs.org
Henry Ford Hospital - Detroit, Michigan 612.3 miles Amy Williamson RN None awillia12@hfhs.org
Henry Ford Hospital - Detroit, Michigan 612.3 miles Amy Williamson RN None awillia12@hfhs.org
Henry Ford Hospital - Detroit, Michigan 612.3 miles Amy Williamson RN None awillia12@hfhs.org
Henry Ford Hospital - Detroit, Michigan 612.3 miles Amy Williamson RN None awillia12@hfhs.org
Wake Forest University Comprehensive Cancer Center - Winston-Salem, North Carolina 659.2 miles Clinical Trials Office 336-713-6771 None

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