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Summary

for people ages 18 years and up
at San Francisco, California
study started
estimated completion:

Description

Summary

This is a single-center cross-sectional imaging study in patients with localized bladder cancer undergoing neoadjuvant atezolizumab as part of a companion clinical trial (NCT02451423; Phase 2 study of atezolizumab in non-metastatic bladder transitional cell carcinoma), and patients with locally advanced or metastatic bladder cancer receiving standard of care (SOC) atezolizumab. For the neoadjuvant cohort, study participants will undergo whole body PET(Positron Emission Tomography)/MR(Magnetic Resonance) imaging with [18F]F-AraG within 7 days of initiating atezolizumab and within 7 days before surgery. For the SOC cohort, study participants will undergo whole body PET/MR imaging with [18F]F-AraG within 7 days of initiating atezolizumab and between Day 14 and Day 21 of Cycle 1 atezolizumab.

Official Title

Functional Imaging of T-cell Activation With [18F]F-AraG in Bladder Cancer Patients Receiving Neoadjuvant or Standard of Care Atezolizumab

Details

This is a single-center cross-sectional imaging study in patients with localized bladder cancer undergoing neoadjuvant atezolizumab as part of a companion clinical trial (NCT02451423; Phase 2 study of atezolizumab in non-metastatic bladder transitional cell carcinoma), and patients with locally advanced or metastatic bladder cancer receiving standard of care (SOC) atezolizumab. For the neoadjuvant cohort, study participants will undergo whole body PET/MR imaging with [18F]F-AraG within 7 days of initiating atezolizumab and within 7 days before surgery. For the SOC cohort, study participants will undergo whole body PET/MR imaging with [18F]F-AraG within 7 days of initiating atezolizumab and between Day 14 and Day 21 of Cycle 1 atezolizumab, where a Simon's two-stage design will be utilized.

A total of 31 patients will be enrolled over an accrual period of approximately 20 months. 12 patients will be enrolled in the neoadjuvant atezolizumab cohort, and approximately 19 patients will be enrolled in the SOC atezolizumab cohort.

Patients will be evaluated one day and one week via telephone visit after each radiopharmaceutical injection for safety follow-up. All adverse events will be recorded. Due to the noninvasive and non-therapeutic nature of the study, potential risks of the study are anticipated to be low.

To the investigator's knowledge, this is the first study to investigate changes in activated T cell localization in the setting of immunotherapy for bladder cancer utilizing functional PET imaging.

Keywords

Bladder Cancer Antibodies, Monoclonal

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Age>18 years
  2. Histologically or cytologically documented bladder transitional cell carcinoma
  3. Eligible for with plan to undergo neoadjuvant treatment with atezolizumab followed by surgery as part of companion study (NCT02451423), or planned to undergo treatment with atezolizumab per standard of care
  4. Must have measurable disease by RECIST v1.1 regardless of disease stage (e.g.localized, locally advanced, or metastatic)
  5. In female patients, negative pregnancy test with no plans to become pregnant during the duration of the study
  6. Able to provide informed consent and follow the study guidelines
  7. Archival tumor tissue from biopsy or Transurethral Resection of Bladder Tumor (TURBT)will be required for all patients. Archival tissue should be of good quality based on total and viable tumor contents. Fine-needle aspiration, brushing, and cytologic cell pellets are not acceptable.

You CAN'T join if...

  1. History of prior treatment with immune checkpoint antibodies (e.g. anti-PD-1,anti-PD-L1, anti-CTLA-4 antibody) or co-stimulatory agonist antibodies (e.g.anti-41BB, anti-OX40)

    a. Prior intravesical treatment with Bacillus Calmette-Guerin (BCG) is allowed.However, the last dose must be at least 6 weeks from time of enrollment and patients must have documented progressive disease at least 6 weeks from completion of last BCG.

  2. Diagnosis of immunodeficiency including history of Human Immunodeficiency Virus (HIV)
  3. Receiving systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to first injection of [18F]F-AraG.

    a. Topical and inhaled corticosteroids are allowed.

  4. Prior allogeneic stem cell or solid organ transplant
  5. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
  6. Biopsy or resection of the primary tumor within 14 days the first injection of[18F]F-AraG
  7. Contraindication to Magnetic Resonance Imaging (MRI) imaging, as determined through review of the University of California San Francisco (UCSF) MRI screening form by qualified site personnel, which includes the presence of pacemaker, aneurysm clip,implanted device, or severe claustrophobia.
  8. Evidence of active infection within 14 days of study enrollment
  9. Female patients who are pregnant or breastfeeding
  10. Inability to receive furosemide (Lasix) in patients with a primary genitourinary tract tumor (e.g. cancers of the bladder, kidney, ureters, urethra, prostate, penis, vagina,uterus, ovaries, or fallopian tubes), including evidence of the following:
  11. Absence of urine formation over last 24 hours
  12. Active pancreatitis
  13. Hearing problem
  14. History of heart attack
  15. Blood pressure drop upon standing resulting in fainting in the last 6 months
  16. Abnormally low blood pressure (systolic pressure < 80mmHg)
  17. Obstruction to outflow of urinary bladder without presence of catheter
  18. Enlarged prostate causing significant difficulty urinating
  19. Systemic lupus erythematosus
  20. Congestive heart failure
  21. High amount of uric acid in the blood if this value is being followed clinically(> 6mg/dL if female;>7mg/dL if male)
  22. Azotemia with Blood Urea Nitrogen (BUN):Creatinine (Cr) ratio> 20
  23. Alkalosis if documented in the medical record within the past 2 weeks
  24. Diabetes
  25. Gout
  26. Low amount of magnesium in the blood (Mg < 1.5)
  27. Low amount of calcium in the blood (Ca < 8.5)
  28. Low amount of sodium in the blood (Na < 135)
  29. Low amount of potassium in the blood (K < 3.5)
  30. Low amount of chloride in the blood (Cl < 97).

Location

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Lawrence Fong
ID
NCT03007719
Phase
Phase 2
Lead Scientist
Lawrence Fong
Study Type
Interventional
Last Updated
July 1, 2017
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