10 Participants Needed

Stereotactic Body Radiation Therapy for Cancer

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: City of Hope Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

Who Is on the Research Team?

Dr. Savita Dandapani, MD – Duarte, CA ...

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)
See 8 more

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
See 4 more

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?
1Treatment groups
Experimental Treatment
Group I: Basic science (zirconium Zr 89-Df-crefmirlimab, PET, SBRT)Experimental Treatment4 Interventions

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

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Approved in United States as Intensity Modulated Radiation Therapy for:
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Approved in European Union as Intensity Modulated Radiation Therapy for:
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Approved in Canada as Intensity Modulated Radiation Therapy for:
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Approved in Japan as Intensity Modulated Radiation Therapy for:
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Approved in China as Intensity Modulated Radiation Therapy for:

Find a Clinic Near You

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

Citations

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 ...
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 ...
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 ...
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.govpubmed.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%, ...
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 ...
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.govpubmed.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.
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 ...
Intensity-Modulated Radiation Therapy Reduces Patient ...Intensity-modulated radiation therapy reduces patient-reported chronic toxicity compared with conventional pelvic radiation therapy.
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