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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-sbrt to post-sbrt (1 week after completion of sbrt)
Awards & highlights

Study Summary

This trial is testing if radiation therapy can help recruit CD8 T cells to help with tumor control.

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.Check my eligibility
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).See study design
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 β€œYes” for the criteria below
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I am 18 years old or older.
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I am able to get out of my bed or chair and move around.
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My cancer has spread and is suitable for targeted radiation therapy.
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I am a woman who can have children and my pregnancy test is negative.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in CD8 positron emission tomography (PET) maximum standardized uptake value (SUVmax)
Secondary outcome measures
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 outcome measures
Correlation between immune characterization of blood samples and CD8 PET SUVs and tumor response

Side effects data

From 2022 Phase 2 trial β€’ 29 Patients β€’ NCT02045446
79%
Cough
64%
Nausea
64%
Dyspnea
57%
Fatigue
43%
Constipation
36%
Pain
36%
Dizziness
29%
Anemia
29%
Back pain
29%
Vomiting
21%
Lymphocyte count decreased
21%
Chest pain
21%
Death NOS
21%
Anorexia
21%
Anxiety
21%
Fall
14%
Wheezing
14%
Hypotension
14%
Depression
14%
Diarrhea
14%
Dysphagia
14%
Platelet count decreased
14%
Abdominal Pain
14%
Edema
14%
Fever
14%
Headache
14%
Insomnia
14%
Palpitations
7%
Hemorrhoids
7%
Amnesia
7%
Dehydration
7%
Dysuria
7%
Hypertension
7%
Creatinine increased
7%
Dysgeusia
7%
Confusion
7%
Dementia
7%
Hypernatremia
7%
Productive cough
7%
Pneumonitis
7%
White blood cell count decreased
7%
Throat pain
7%
Bone marrow biopsy
7%
Blurred vision
7%
Hearing impaired
7%
Rash
7%
Eye pain
7%
Tachycardia
7%
Lung infection
7%
Neuropathy
7%
Pleuritic pain
7%
Neutropenia
7%
Hypoxia
7%
Aspiration pneumonia
7%
Blood bilirubin increased
7%
Muscle weakness
7%
Tremor
7%
Weight loss
7%
Thrombocytopenia
7%
Floaters
7%
Toothache
7%
Sinusitis
7%
Alopecia
7%
Esophagitis
7%
Otitis externa
7%
Leukocytosis
7%
Edema limbs
7%
Gait disturbance
7%
Parathesia (tingling)
7%
Edema face
7%
COPD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Body Radiation Therapy
Maintenance Chemotherapy

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
2008
Completed Phase 2
~2260
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Intensity Modulated Radiation Therapy
2017
Completed Phase 2
~490

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
561 Previous Clinical Trials
1,918,242 Total Patients Enrolled
97 Trials studying Lymphoma
6,460 Patients Enrolled for Lymphoma
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,337 Total Patients Enrolled
1,377 Trials studying Lymphoma
381,618 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies remaining for participants in this research trial?

"Affirmative. Clinicaltrials.gov has reported that this medical trial, which was initially published on June 20th 2022, is still recruiting patients. The research team requires 10 volunteers from a single clinic to participate in the study."

Answered by AI

Are there any risks associated with Stereotactic Body Radiation Therapy for patients?

"The safety of Stereotactic Body Radiation Therapy is rated as a 1 since this experimental trial only has limited evidence for its efficacy and safety."

Answered by AI

How many test subjects are receiving treatment in this experiment?

"Affirmative. According to the details on clinicaltrials.gov, this study is actively recruiting patients - with 10 individuals required from a single location - since it was first posted in June 2022 and revised last November."

Answered by AI
~0 spots leftby Apr 2024