Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion
Principal Investigator
by C. Babis Andreadis, MD (ucsf)
Photo of C. Babis Andreadis
C. Babis Andreadis

Description

Summary

This study evaluates whether tumors present in patients with cancer who are planned to get CAR T-cells have low amounts of oxygen (hypoxia). PET scans may be used to check the amounts of oxygen within areas of cancer with a special radioactive tracer called FAZA that specifically looks for areas of low oxygen. This study is being done to help researchers determine how the amount of oxygen within areas of cancer affect how well CAR T-cells kill cancer cells.

Official Title

Pilot Study of Hypoxia-Specific Imaging to Predict Outcomes of Chimeric Antigen Receptor T-Cell Therapy

Details

PRIMARY OBJECTIVE:

  1. To evaluate the incidence of intratumoral hypoxia in patients with relapsed or refractory (R/R) malignancies before treatment with chimeric antigen receptor (CAR) T-cell therapy.

SECONDARY OBJECTIVE:

  1. To evaluate the association between intratumoral hypoxia and clinical responses to CAR T-cell therapy.

EXPLORATORY OBJECTIVES:

  1. To correlate intratumoral hypoxia with markers of CAR T-cell activity and toxicity.
  2. To correlate pre-therapy fluorine F 18-fluoroazomycin arabinoside (18F-FAZA) uptake with pre-therapy 18Ffluorodeoxyglucose (FDG) positron emission tomography (PET) uptake.

OUTLINE:

Prior to CAR T-cell therapy, patients receive 18F-FAZA intravenously (IV). Beginning 2 hours after injection, patients undergo PET scan over 30-45 minutes.

After completion of study, patients are followed up for up to 6 months after CAR T-cell therapy.

Keywords

Recurrent Aggressive Non-Hodgkin Lymphoma Recurrent Diffuse Large B-Cell Lymphoma Recurrent High Grade B-Cell Lymphoma Recurrent Malignant Neoplasm Recurrent Plasma Cell Myeloma Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma Refractory Aggressive Non-Hodgkin Lymphoma Refractory Diffuse Large B-Cell Lymphoma Refractory High Grade B-Cell Lymphoma Refractory Malignant Neoplasm Refractory Plasma Cell Myeloma Refractory Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma Lymphoma Neoplasms Multiple Myeloma Neoplasms, Plasma Cell Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Hypoxia Recurrence Aggression Fluoroazomycin arabinoside Fluorine F 18-fluoroazomycin Arabinoside Positron Emission Tomography

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically confirmed diagnosis of:
  • Aggressive lymphoma, including: Diffuse large B-cell lymphoma (DLBCL) (including transformed disease), high-grade B-cell lymphoma, or primary mediastinal B-cell lymphoma
  • Multiple myeloma (MM), with imaging within 6 months of enrollment demonstrating >= 1 plasmacytoma measuring >= 5 cm along any axis
  • Other malignancy with radiographically measurable disease
  • R/R disease with planned receipt of CAR T-cell therapy at University of California, San Francisco (UCSF), either through an Food and Drug Administration-approved CAR construct or through a separate interventional clinical trial
  • Planned 18F-FDG PET scan before receipt of CAR T-cell therapy
  • Ability to provide informed consent prior to study entry

You CAN'T join if...

  • Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with participant's safety, provision of informed consent, or compliance with study procedures
  • Body weight over 300 pounds (precluding use of PET scanner)
  • Pregnancy or active lactation

Location

  • University of California, San Francisco
    San Francisco California 94143 United States

Lead Scientist at UC Health

Details

Status
currently not accepting new patients, but might later
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04409314
Study Type
Observational
Last Updated