Is NCT05039281 recruiting in Houston, TX?

Yes, NCT05039281 is currently recruiting participants at its Houston, TX location. This recurrent glioblastoma clinical trial is actively enrolling qualified participants.

How do I join the recurrent glioblastoma clinical trial in Houston?

To join this clinical trial in Houston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Houston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Recurrent Glioblastoma Clinical Trial in Houston, TX

About This Recurrent Glioblastoma Study in Houston

This phase I/II trial tests the safety and side effects of atezolizumab in combination with cabozantinib and whether they work to shrink tumors in patients with glioblastoma that has come back (recurrent). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atezolizumab and cabozantinib may help control the disease in patients with recurrent glioblastoma.

Sponsor: M.D. Anderson Cancer Center

Who Can Participate

Inclusion Criteria

Signed informed consent form (ICF)

Ability and willingness to comply with the requirements of the study protocol

Age \>= 18 years

Have histologically confirmed World Health Organization grade IV glioma (glioblastoma or gliosarcoma). Archival tissue will be required for diagnosis confirmation. Receipt of archival tissue is not required for the start of treatment

Patients must have been previously treated with radiation and temozolomide

Patients must be at least 12 weeks out from completion of concurrent chemoradiation

Have a performance status of \>= 60 on the Karnofsky performance status (KPS)

Patients at either first or second recurrence will be considered eligible

A baseline brain magnetic resonance imaging (MRI) obtained no more than 14 days prior to study enrollment

Absolute neutrophil count (ANC) \>= 1,500 /mcL

Platelets \>= 100,000 /mcL

Hemoglobin \>= 9 g/dL or \>= 5.6 mmol/L

Serum creatinine =\< 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\]) \>= 60 mL/min for subject with creatinine levels \> 1.5 X institutional ULN

Creatinine clearance should be calculated per institutional standard

Urine protein/creatinine ratio (UPCR) =\< 1 mg/mg (=\< 113.2 mg/mmol) OR 24 hour (h) urine protein =\< 1g

Serum total bilirubin =\< 1.5 X ULN OR direct bilirubin =\< ULN for subjects with total bilirubin levels \> 1.5 ULN

Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 2.5 X ULN

Serum albumin \>= 2.8 g/dl

International normalized ratio (INR) or prothrombin time (PT) activated partial thromboplastin time (aPTT) =\< 1.3 X ULN

All screening labs should be performed within 14 days (+3 working days) of treatment initiation

Female subject of childbearing potential should have a negative serum pregnancy test within 14 days (+/- 3 working days) of study enrollment

Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the duration of the study and 5 months after the last dose of study treatment. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year

Male subjects should agree to use an adequate method of contraception during the course of the study and 5 months after the last dose of study treatment

Exclusion Criteria

Has received prior interstitial brachytherapy, implanted chemotherapy, or therapeutics delivered by local injection or convection enhanced delivery. Prior treatment with Gliadel wafers will be excluded. Active treatment with the Optune device will be excluded

Has received radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment, or systemic treatment with radionuclides within 6 weeks before first dose of study treatment

Has clinically relevant ongoing complications from prior radiation therapy

Is currently participating in any other recurrent therapeutic trial after completion of chemoradiation

Has history of cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation

Any serious medical condition that interferes with adherence to study procedures

Malignancies other than the disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai Stage 0)

Has known leptomeningeal disease, gliomatosis cerebri, extracranial disease, or multifocal disease. Subject has multifocal glioblastoma (GBM), defined as discrete sites of contrast enhancing disease without contiguous T2/fluid attenuated inversion recovery (FLAIR) abnormality that require distinct radiotherapy ports. Satellite lesions that are associated with a contiguous area of T2/FLAIR abnormality as the main lesion(s) and that are encompassed within the same radiotherapy port as the main lesion(s) are permitted

Has history of interstitial lung disease or active, non-infectious pneumonitis

Has an active infection requiring systemic therapy

Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator

Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit

Contraindication for undergoing MRIs

Inability to comply with study and follow-up procedures

History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis

Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible

Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible

Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:

Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations

Rash must cover less than 10% of body surface area (BSA)

Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)

No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation \[PUVA\], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)

Has a medical history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or active pneumonitis

History of radiation pneumonitis in the radiation field (fibrosis) is permitted

Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications

History of human immunodeficiency virus (HIV) infection or active hepatitis B (HBV) (chronic or acute) or hepatitis C infection

Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen \[HBsAg\] test and a positive anti-HBc \[antibody to hepatitis B core antigen\] antibody test) are eligible. Patients will be sampled for HBV DNA and will be referred to a virologist to monitor for HBV re-activation

Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA

Active tuberculosis

Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia

Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1

Received oral or IV antibiotics within 2 weeks prior to cycle 1, day 1

Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible

Anticipation of need for a major surgical procedure (e.g., laparoscopic nephrectomy, gastrointestinal \[GI\] surgery, removal or biopsy of brain metastasis) within 2 weeks before first dose of study treatment, or of need for a minor surgery within 10 days before first dose of study treatment. Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible

Administration of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or anticipation that such a live, attenuated vaccine will be required during the study

Influenza vaccination should be given during influenza season only (approximately October to March). Patients must not receive live, attenuated influenza vaccine (e.g., FluMist) within 4 weeks prior to cycle 1, day 1 or at any time during the study and for 5 months after last dose of atezolizumab

Patients may not receive concomitant chemotherapy, hormonal therapy, immunotherapy, or radiotherapy while patients are on study

MEDICATION-RELATED EXCLUSION CRITERIA:

Prior treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents

Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment

Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment

Prior treatment with anti-angiogenic (e.g. anti-vascular endothelial growth factor \[VEGF\]) therapeutic antibody or pathway targeting agents

Treatment with systemic immunostimulatory agents (including but not limited to interferon \[IFN\]- or interleukin \[IL\]-2) within 6 weeks or five half-lives of the drug (whichever is shorter) prior to cycle 1, day 1

Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 2 weeks prior to cycle 1, day 1

Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled

The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed

History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies, fusion proteins or components of cabozantinib

Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation

Evidence of recent hemorrhage on post-operative MRI of the brain, however patients with clinically asymptomatic presence of hemosiderin, resolving post-operative changes and punctate intratumoral hemorrhage are permitted

Known lesions invading or encasing any major blood vessels. Subjects with lesions invading the intrahepatic vasculature, including portal vein, hepatic vein, and hepatic artery, are eligible

Corrected QT interval calculated by the Fridericia formula (QTcF) \> 500 ms per electrocardiogram (ECG) within 14 days before first dose of study treatment

Note: if a single ECG shows a QTcF with an absolute value \> 500 ms, two additional ECGs at intervals of approximately 3 min must be performed within 30 minutes after the initial ECG, and the average of these three consecutive results for QTcF will be used to determine eligibility

Inability to swallow tablets

Inadequately controlled hypertension (defined as systolic blood pressure \> 140mmHg and/or diastolic blood pressure \> 90mmHg)

A history of or active nephrotic syndrome

Prior history of hypertensive crisis or hypertensive encephalopathy

New York Heart Assocation (NYHA) grade II or greater congestive heart failure

History of myocardial infarction or unstable angina within 6 months prior to study enrollment

History of stroke or transient ischemic attack (TIA) within 6 months prior to study enrollment

Significant vascular disease (e.g. aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to study enrollment

History of clinically significant hematuria, hematemesis, or hemoptysis of \> 0.5 teaspoon (2.5 ml) of red blood, or any other history of significant bleeding (e.g. pulmonary hemorrhage) within 12 weeks before first dose of study treatment

Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)

Major surgical procedure, open biopsy, intracranial biopsy, ventriculoperitoneal shunt or significant traumatic injury within 28 days prior to study enrollment

Core biopsy (excluding intracranial biopsy) or other minor surgical procedure within 107 days prior to study enrollment. Placement of a central vascular access device if performed within 2 days prior to cabozantinib administration

History of abdominal fistula, bowel obstruction, gastrointestinal perforation or intra-abdominal abscess within 6 months before first dose of study treatment

Note: complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment

History of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction

History of intracranial abscess within 6 months prior to study enrollment

Clinically-significant disorders that would preclude safe study participation

Serious non-healing wound, active ulcer or untreated bone fracture

Uncompensated/symptomatic hypothyroidism

Moderate to severe hepatic impairment (Child-Pugh B or C)

Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g. , dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel)

Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH) are allowed

Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor are also allowed

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Houston?

Yes, this clinical trial (NCT05039281) has an active research site in Houston, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Recurrent Glioblastoma Treatment Options in Houston, TX

If you're searching for recurrent glioblastoma treatment options in Houston, TX, this clinical trial (NCT05039281) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced recurrent glioblastoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all recurrent glioblastoma clinical trials near you to find additional studies recruiting in your area.

Recurrent Glioblastoma Clinical Trial in Houston, TX

Expert Care in Houston

IRB Approved

No-Cost Care

Apply for This Houston Location

Why Participate?

Simple Process