Stereotactic Body Radiation Therapy for Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: City of Hope Medical Center

Disqualifiers: Splenic disorders, Uncontrolled illness, Allergic reactions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 2-3 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how stereotactic body radiation therapy affects the immune system's CD8+ T cells. These cells play a crucial role in infiltrating and killing tumor cells, potentially aiding in cancer control. The trial includes patients with lymphoma and those with metastatic solid tumors to determine if radiation can effectively recruit these cells to combat cancer. Candidates should have a solid tumor treatable with this radiation type and should not have changed their treatment plan in the last two months. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require no change in your systemic treatment regimen for 2 months before starting the radiation therapy. It's best to discuss your specific medications with the trial team.

What prior data suggests that this radiation therapy is safe?

Research has shown that Stereotactic Body Radiation Therapy (SBRT) is generally safe and well-tolerated. Studies have found positive results, particularly for patients with certain types of cancer. For instance, patients with oligometastatic cancer—a condition where cancer has spread but remains limited in number and location—have found SBRT both safe and manageable.

Intensity Modulated Radiation Therapy (IMRT) is also considered safe. One study found that IMRT reduced long-lasting side effects compared to traditional radiation methods, meaning patients may experience fewer side effects over time.

Both SBRT and IMRT have demonstrated promising safety in previous research. These therapies target tumors more precisely, helping to limit damage to healthy tissues. This precision reduces the chance of harmful side effects. While side effects can occur, evidence suggests these treatments are generally well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this approach because Stereotactic Body Radiation Therapy (SBRT) offers precise targeting of tumors, which could reduce damage to surrounding healthy tissue compared to traditional radiation therapy options like External Beam Radiation Therapy (EBRT). SBRT allows for higher doses of radiation to be delivered in fewer sessions, potentially improving treatment outcomes and convenience for patients. Additionally, the use of zirconium Zr 89-Df-crefmirlimab in combination with PET imaging could enhance the accuracy of tumor targeting, further boosting the efficacy and safety of the treatment.

What evidence suggests that Stereotactic Body Radiation Therapy could be effective for cancer?

Research has shown that Stereotactic Body Radiation Therapy (SBRT), one of the treatments in this trial, effectively controls tumors. One study found that 89.1% of tumors did not grow for two years after treatment. Another study showed that 88% of tumors either completely or partially shrank.

For Intensity Modulated Radiation Therapy (IMRT), which may be used for lymphoma patients in this trial, research indicates it effectively treats lymphoma. One study reported that 68% of patients were still alive five years after treatment, suggesting a good long-term survival rate. Another study found that patients treated with IMRT had better overall outcomes compared to another method. ^{6 7 8 9 10}

Who Is on the Research Team?

Savita Dandapani, MD

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Documented informed consent of the participant and/or legally authorized representative

Participant is willing and able to comply with all protocol required procedures

Lymphoma patients may be allowed as determined by the principal investigator (PI)

Exclusion Criteria

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures

History of allergic reactions attributed to compounds of similar chemical or biologic composition to CD8 PET tracer

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive zirconium Zr 89-Df-crefmirlimab IV and undergo PET imaging before and after SBRT. SBRT is administered every 2-5 days for a total of 5 fractions.

2-3 weeks

Multiple visits for SBRT and PET imaging

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 4-6 weeks, 3 months, 1 year, and periodically for 2 years.

2 years

Follow-up visits at 4-6 weeks, 3 months, 1 year, and periodically for 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Intensity Modulated Radiation Therapy
• Positron Emission Tomography
• Stereotactic Body Radiation Therapy

Trial Overview

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).

How Is the Trial Designed?

Group I: Basic science (zirconium Zr 89-Df-crefmirlimab, PET, SBRT) Experimental Treatment 4 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.

Intensity Modulated Radiation Therapy is already approved in United States, European Union, Canada, Japan, China for the following indications:

Approved in United States as Intensity Modulated Radiation Therapy for:

• Various types of cancer, including but not limited to prostate cancer, head and neck cancer, lung cancer, breast cancer, brain tumors, and spinal tumors

Approved in European Union as Intensity Modulated Radiation Therapy for:

• Various types of cancer, including but not limited to prostate cancer, head and neck cancer, lung cancer, breast cancer, brain tumors, and spinal tumors

Approved in Canada as Intensity Modulated Radiation Therapy for:

• Various types of cancer, including but not limited to prostate cancer, head and neck cancer, lung cancer, breast cancer, brain tumors, and spinal tumors

Approved in Japan as Intensity Modulated Radiation Therapy for:

• Various types of cancer, including but not limited to prostate cancer, head and neck cancer, lung cancer, breast cancer, brain tumors, and spinal tumors

Approved in China as Intensity Modulated Radiation Therapy for:

• Various types of cancer, including but not limited to prostate cancer, head and neck cancer, lung cancer, breast cancer, brain tumors, and spinal tumors

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Stereotactic ablative body radiotherapy (SABR) is now the standard treatment for early-stage non-small-cell lung cancer (NSCLC) in patients who cannot undergo surgery, highlighting its efficacy in this patient population.

The review also discusses the safety profile of SABR, including reported toxicity rates, and explores its potential use in combination with other therapies for improved outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of outcomes following stereotactic ablative radiotherapy in the treatment of early-stage primary lung cancer. Murray, P., Franks, K., Hanna, GG.[2022]

In a study of 100 patients with early-stage non-small cell lung cancer (NSCLC) treated with stereotactic ablative body radiotherapy (SABR), the 1-, 2-, and 3-year local control rates were 100%, 93.55%, and 84.33%, respectively, indicating high efficacy in tumor control.

The treatment was associated with low toxicity, with only 2% of patients experiencing Grade-3 side effects, suggesting that SABR is a safe option for patients who are inoperable or refuse surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definitive Treatment of Early-Stage Non-Small Cell Lung Cancer with Stereotactic Ablative Body Radiotherapy in a Community Cancer Center Setting. Heal, C., Ding, W., Lamond, J., et al.[2020]

In a study of 73 patients with metastatic lung tumors treated using the CyberKnife system, stereotactic ablative body radiotherapy (SABR) demonstrated high effectiveness, achieving a 2-year local control rate of 89.1% and an overall survival rate of 71.3%.

The treatment was associated with acceptable toxicity levels, with only two cases of grade 2 or higher radiation pneumonitis, indicating that SABR with a central high dose is a safe option for managing metastatic lung tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy with a central high dose using CyberKnife for metastatic lung tumors. Hayashi, K., Suzuki, O., Shiomi, H., et al.[2023]

Stereotactic ablative radiotherapy (SABR) using Cyberknife demonstrated high effectiveness in treating stage I non-small-cell lung cancer, with 2-year local control, progression-free, and overall survival rates of 91.9%, 61.7%, and 84.8%, respectively, based on a study of 153 patients.

The treatment was generally safe, with only 8.1% of patients experiencing severe toxicities, including one case of grade 5 radiation pneumonitis, indicating that while SABR is effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. Hayashi, K., Suzuki, O., Shiomi, H., et al.[2022]

Stereotactic ablative radiotherapy (SABR) is an effective treatment for early-stage non-small cell lung cancers (NSCLCs) that are medically inoperable, providing local control and toxicity levels comparable to surgical resection.

SABR is gaining interest as a noninvasive treatment option for patients with borderline resectable lung cancers, although further randomized studies are needed to evaluate its survival benefits in operable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. Iyengar, P., Westover, K., Timmerman, RD.[2013]

Stereotactic ablative radiotherapy (SABR) is an effective treatment for early-stage non-small cell lung cancer, especially for patients who cannot undergo surgery, showing high local tumor control rates with manageable side effects.

The CyberKnife system is particularly advantageous for SABR in lung tumors due to its ability to accurately target moving tumors during breathing, enhancing treatment precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CyberKnife stereotactic ablative radiotherapy for lung tumors. Gibbs, IC., Loo, BW.[2022]

Cyberknife stereotactic ablative radiotherapy (SABR) demonstrated a 71.6% objective response rate in 53 patients with unresectable hepatocellular carcinoma (HCC), indicating its efficacy as a salvage treatment when other therapies failed.

The median survival time for patients treated with SABR was 20 months, with 1- and 2-year overall survival rates of 70.1% and 45.4%, respectively, suggesting that while SABR is effective, there is a need to address issues like out-field recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy for unresectable hepatocellular carcinoma patients who failed or were unsuitable for transarterial chemoembolization. Lo, CH., Huang, WY., Lee, MS., et al.[2022]

CyberKnife stereotactic ablative radiotherapy (SABR) for treating intermediate- to very-high-risk prostate cancer showed a high 3-year biochemical relapse-free survival rate of 90.2%, indicating its efficacy in managing this condition.

The treatment was well-tolerated, with no patients experiencing severe toxicity (≥ grade 3), and only mild genitourinary and gastrointestinal side effects were reported, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. Fan, CY., Chao, HL., Huang, WY., et al.[2017]

Stereotactic ablative body radiotherapy (SABR) is a feasible and well-tolerated treatment for patients with bone-only oligometastatic breast cancer, with 80% of patients successfully receiving treatment and no severe (grade 3 or 4) toxicities reported.

The treatment showed promising efficacy, with a 100% local progression-free survival (LPFS) and 67% distant progression-free survival (DPFS) at two years, suggesting that SABR could be a viable option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial. David, S., Tan, J., Savas, P., et al.[2020]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10854861/

Long-Term Results of IFRT vs. ISRT in Infradiaphragmal ...

The survival rates in our study (68% at 5 years) are consistent with lymphoma outcomes. According to the National Cancer Institute data from ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1040842821002250

A Systematic Review on Intensity Modulated Radiation ...

We performed a systematic review of the current literature regarding comparisons between IMRT and conventional photon beam radiotherapy, or between different ...

3.

redjournal.org

redjournal.org/article/S0360-3016(23)07944-0/fulltext

Phase 2 Clinical Trial of Simultaneous Boost Intensity ...

This study achieved favorable clinical outcomes, as well as satisfactory long-term QOL for patients. The scheme of target volume delineation and ...

4.

ar.iiarjournals.org

ar.iiarjournals.org/content/41/10/5131

Intensity-modulated Radiotherapy in Patients With ...

Results: The median follow-up was 42 months. Patients treated with IMRT experienced higher overall responde rate than patients who received 3DCRT (85% vs. 73%, ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/27034178/

Intensity Modulated Radiation Therapy for Early-Stage ...

The 5-year overall survival (OS), progression-free survival, and locoregional control rates for all patients were 80.4%, 75.0%, and 93.2%, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6791404/

Ten-Year Outcomes Of Intensity-Modulated Radiotherapy ...

Both univariable and multivariable analyses showed that the addition of chemotherapy to IMRT did not significantly improve the 10-year survival outcomes. The ...

7.

astro.org

astro.org/news-and-publications/news-and-media-center/news-releases/2025/imrt-matches-proton-therapy-in-patient-reported-outcomes-for

Intensity-modulated radiation therapy (IMRT) matches ...

At a median follow-up of 28.3 months, two-year freedom from cancer returning at or near the original tumor site was 94.3% for protons and 96.8% ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39007360/

Efficacy and safety of proton therapy versus intensity ...

Proton therapy demonstrated superior overall survival (OS), disease-free survival (DFS), and better local control rate (LCR) compared to IMRT.

9.

sciencedirect.com

sciencedirect.com/science/article/pii/S2331518023002354

Outcomes of Proton Beam Therapy Compared With ...

Our data show PT may decrease the frequency of diarrhea at the end of radiation therapy and lower the risk of bowel incontinence at 12 months as compared with ...

10.

ascopubs.org

ascopubs.org/doi/abs/10.1200/JCO.21.02831

Intensity-Modulated Radiation Therapy Reduces Patient ...

Intensity-modulated radiation therapy reduces patient-reported chronic toxicity compared with conventional pelvic radiation therapy.