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Stereotactic Body Radiation Therapy for Major Salivary Gland Cancer
Study Summary
This trial is testing the side effects and efficacy of nivolumab and ipilimumab given with stereotactic body radiation therapy for patients with salivary gland cancers.
- Stage IV Major Salivary Gland Cancer
- Bone Metastasis
- Major Salivary Gland Cancer
- Lung Cancer
- Salivary Gland Cancer
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 trial • 29 Patients • NCT02045446Trial Design
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- You have cancer that has spread to your brain or spinal cord, unless it has been stable and you have not taken steroids for at least 14 days before the study treatment.You have an autoimmune disease that requires treatment or has been severe within the past 2 years.You have a mental health or substance abuse issue that may make it difficult for you to follow the study requirements.You have been treated with a specific type of medication called monoclonal antibodies within the last 4 weeks, or you still have side effects from medications taken more than 4 weeks ago.You have cancer in your salivary gland that has spread to your head, neck, lungs, or bones and you are not eligible for curative treatment.Your condition has continued to worsen despite treatment with the most recent medication, or if you have not received any prior medication, your condition has worsened within the last 3 months according to your doctor.You are physically able to lie flat and stay still during the required SBRT treatments, according to your doctor's assessment.You need to provide a sample of your tumor tissue, either from a previous biopsy or a new one. If getting a tissue sample is not recommended or not possible, the study doctor may approve a waiver of this requirement.You are in good physical condition and have a score of 0 or 1 on the ECOG performance scale.You have had an organ transplant before or have a weakened immune system from birth.You have an ongoing illness that is not under control.You cannot have taken part in another clinical trial using a new drug or device within the past four weeks.The target lesion/s for this treatment require specific size or location.You have cancer that started in the salivary gland and has spread to other parts of the head and neck, lungs, or bones. The cancer cannot be cured with current treatments.You have already received treatment for your condition in the past.You must be willing to sign a form saying you agree to participate in the study and commit to attending all scheduled visits.You have a detectable medical condition that can be measured using a specific scale called RECIST 1.1, besides the one being treated with stereotactic radiation therapy.Your hemoglobin level, which measures the amount of oxygen in your blood, is at least 9.0 grams per deciliter.You have up to three tumors in the head and neck region or cancer that has spread to the lung or bone, which will be treated with a type of radiation called SBRT. You also have other measurable tumors that will be monitored according to standard guidelines. If the area being treated with SBRT was previously treated with high doses of radiation, there should be at least a six month gap before starting SBRT.You have received any type of treatment using medications for your condition before.
- Group 1: Treatment (nivolumab, ipilimumab, SBRT)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What type of cancer does Stereotactic Body Radiation Therapy usually target?
"While it is most commonly used as a follow-up to anti-angiogenic therapy, Stereotactic Body Radiation Therapy can also be used to treat malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."
Does Stereotactic Body Radiation Therapy have a long and varied history?
"Currently, Stereotactic Body Radiation Therapy is being studied in 86 different Phase 3 trials. Out of the 796 ongoing research projects, 43300 are based out of Pittsburgh, Pennsylvania."
Are people currently being enrolled in this clinical trial?
"This study is no longer looking for patients. The trial was first posted on 1/15/2019 and ended on 9/19/2022. However, there are other trials you may be eligible for; 2664 clinical trials are actively recruiting patients with larynx cancer and 796 trials for Stereotactic Body Radiation Therapy are also searching for participants."
How many people are signing up to participate in this research?
"Unfortunately, this particular trial is not enrolling patients at the moment. However, it's worth noting that there are 2664 other trials for larynx-related issues and 796 different trials related to Stereotactic Body Radiation Therapy currently underway."
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