← Back to Search

Radiation Therapy

Stereotactic Body Radiation Therapy for Cancer

Phase 1
Recruiting
Led By Savita V Dandapani
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age: >= 18 years
Eastern Cooperative Oncology Group (ECOG) =< 2
Must not have
Females only: Pregnant or breastfeeding
Patients should not have any uncontrolled illness including ongoing or active infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-sbrt to post-sbrt (1 week after completion of sbrt)
Awards & highlights

Summary

This trial uses radiation therapy and a special PET scan to help lymphoma and metastatic solid tumor patients. The radiation attracts immune cells to fight the cancer, and the scan checks if these cells are working properly.

Who is the study for?
Adults (18+) with lymphoma or solid tumor malignancies suitable for radiation therapy, able to follow the trial's procedures. They must have stable treatment for 2 months prior and be willing to undergo daily PET scans post-radiation. Women of childbearing age need a negative pregnancy test and agree to use contraception.
What is being tested?
This phase I trial is testing how radiation affects immune cells in cancer patients by using a special PET scan tracer before and after radiation therapy. The goal is to see if this can help monitor immune response in patients getting CAR T-cell infusion or stereotactic body radiation therapy (SBRT).
What are the potential side effects?
Potential side effects are not detailed but may include reactions related to the CD8 PET tracer used for imaging, similar to those seen with other compounds of its class. Side effects from the radiation therapy itself could also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am able to get out of my bed or chair and move around.
Select...
My cancer has spread and is suitable for targeted radiation therapy.
Select...
I am a woman who can have children and my pregnancy test is negative.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not pregnant or breastfeeding.
Select...
I do not have any uncontrolled illnesses or active infections.
Select...
I have a spleen condition or had my spleen removed that may affect CD8 imaging.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-bridging radiation to post-car t cell therapy (approximately at least 7 days after car t cell infusion). additional response and survival data will be collected up to 2 years after completion of study therapy.
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-bridging radiation to post-car t cell therapy (approximately at least 7 days after car t cell infusion). additional response and survival data will be collected up to 2 years after completion of study therapy. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in CD8 positron emission tomography (PET) maximum standardized uptake value (SUVmax)
Secondary study objectives
CD8 PET SUV (Subset)
Evaluation of tumor response (fludeoxyglucose F-18 [FDG] PET and/or computed tomography [CT]) as it relates to both baseline CD8 PET SUV and changes observed after SBRT.
Histology specific differences in immune characterization (CD8 PET SUV) and changes
+3 more
Other study objectives
Correlation between immune characterization of blood samples and CD8 PET SUVs and tumor response

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446
87%
Fatigue
53%
Nausea
33%
Cough
27%
Dyspnea
27%
Depression
27%
Platelet count decreased
27%
Anemia
27%
Pain
27%
Fall
27%
Lymphocyte count decreased
20%
Chills
20%
Edema limbs
20%
Neutropenia
20%
Diarrhea
20%
Dizziness
20%
Chest pain
13%
Dysesthesia
13%
Edema
13%
Vomiting
13%
Tinnitus
13%
Skin infection
13%
Myalgia
13%
Rash
13%
Back pain
13%
Insomnia
13%
Constipation
13%
Delirium
13%
Dysgeusia
13%
Weakness (limb)
13%
Weight loss
7%
Hypoxic respiratory failure
7%
Hypernatremia
7%
Seizures
7%
Headaches
7%
Death NOS
7%
Encephalopathy
7%
Gait disturbance
7%
Fever
7%
Sneezing
7%
Tremor
7%
Amnesia
7%
Oral lesions
7%
Neutrophil count decreased
7%
Photophobia
7%
Pleural effusion
7%
Proteinuria
7%
Urinary frequency
7%
Cognitive disturbance
7%
Muscle weakness
7%
Lung infection
7%
Acute kidney injury
7%
Hypertension
7%
Allergy (seasonal)
7%
Dysphagia
7%
Bruising
7%
Low white blood count
7%
Hypomagnesemia
7%
Nasal congestion
7%
Parathesia (tingling)
7%
Febrile Neutropenia
7%
Anxiety
7%
Anorexia
7%
Creatinine increased
7%
Hypokalemia
7%
Erythema multitforme
7%
Headache
7%
Hearing impaired
7%
Hearing loss
7%
Lymphocytopenia
7%
Sleep apnea
7%
Urinary urgency
7%
Weakness (facial)
7%
Hypoxia
7%
Shingles
100%
80%
60%
40%
20%
0%
Study treatment Arm
Maintenance Chemotherapy
Stereotactic Body Radiation Therapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: Basic science (zirconium Zr 89-Df-crefmirlimab, PET, SBRT)Experimental Treatment4 Interventions
Patients receive zirconium Zr 89-Df-crefmirlimab IV over 5-10 minutes and then under PET imaging 24 hours after infusion before and after SBRT. Patients undergo SBRT every 2-5 days for a total of 5 fractions. For lymphoma patients only, IMRT on consecutive days may be used.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2011
Completed Phase 2
~2200
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~790
Intensity Modulated Radiation Therapy
2017
Completed Phase 2
~490

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
596 Previous Clinical Trials
1,923,527 Total Patients Enrolled
101 Trials studying Lymphoma
6,550 Patients Enrolled for Lymphoma
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,990 Total Patients Enrolled
1,399 Trials studying Lymphoma
382,853 Patients Enrolled for Lymphoma
Savita V DandapaniPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
33 Total Patients Enrolled
1 Trials studying Lymphoma
9 Patients Enrolled for Lymphoma
~3 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top