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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

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

No Placebo-Only Group

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

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I do not have any uncontrolled illnesses or active infections.

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I have a spleen condition or had my spleen removed that may affect CD8 imaging.

Timeline

Screening ~ 3 weeks3 visits

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.

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%

Pain

27%

Fall

27%

Dyspnea

27%

Depression

27%

Lymphocyte count decreased

27%

Platelet count decreased

27%

Anemia

20%

Chills

20%

Dizziness

20%

Chest pain

20%

Neutropenia

20%

Diarrhea

20%

Edema limbs

13%

Dysesthesia

13%

Insomnia

13%

Edema

13%

Constipation

13%

Delirium

13%

Dysgeusia

13%

Skin infection

13%

Vomiting

13%

Tinnitus

13%

Rash

13%

Myalgia

13%

Back pain

13%

Weakness (limb)

13%

Weight loss

Proteinuria

Bruising

Hearing loss

Anxiety

Oral lesions

Headaches

Acute kidney injury

Hypokalemia

Lymphocytopenia

Seizures

Weakness (facial)

Hearing impaired

Neutrophil count decreased

Death NOS

Hypertension

Headache

Creatinine increased

Fever

Pleural effusion

Gait disturbance

Nasal congestion

Tremor

Urinary urgency

Amnesia

Hypernatremia

Photophobia

Urinary frequency

Dysphagia

Low white blood count

Sneezing

Cognitive disturbance

Erythema multitforme

Lung infection

Allergy (seasonal)

Muscle weakness

Hypomagnesemia

Parathesia (tingling)

Febrile Neutropenia

Anorexia

Hypoxic respiratory failure

Sleep apnea

Encephalopathy

Hypoxia

Shingles

100%

80%

60%

40%

20%

Study treatment Arm

Maintenance Chemotherapy

Stereotactic Body Radiation Therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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