Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Trial of Salvage Radiation Therapy to Induce Systemic Disease Regression After Progression on Systemic Immunotherapy

Summary: The goal of this clinical research study is to learn if using radiation therapy can help to control the cancer after the disease has gotten worse after receiving immunotherapy.
  This is an investigational study. Radiation therapy is delivered using FDA approved and commercially available methods. It is considered investigational to use radiation therapy in patients whose disease has gotten worse after receiving immunotherapy.
  The study doctor can explain how radiation therapy is designed to work.
  Up to 150 participants will take part in this study. All will be enrolled at MD Anderson.

Detailed description: Study Groups and Radiation Therapy:
  If you are found to be eligible to take part in this study, you will receive radiation therapy. The radiation oncologist will decide what type of radiation you receive. Depending on the type of radiation that is chosen for you, you may receive radiation anywhere between 4 days to 3 weeks. The study doctor will discuss what type of radiation you will have and how often you will receive it. You may be receiving sub-therapeutic doses of radiation.
  Within 7 days before you begin radiation therapy, you will have radiation simulation to plan radiation treatment. During radiation simulation, you will go through the motions of receiving radiation (though you will not receive radiation) to help you understand the radiation process. This will also help the doctor know where to "aim" the radiation when you receive radiation. This may take up to 1 hour.
  Study Visits:
  At start of your radiation therapy and then every 4-12 weeks while you are on study:
  -  You will have a physical exam.
  -  You will have an MRI, CT, or PET/CT scan. You will not have these scans the day after you receive radiation therapy.
  Length of Study:
  You may receive radiation for up to 3 weeks. However, you will continue to have study visits every 4-12 weeks. You will continue having study visits unless the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
  Your participation on the study will be over after you have completed the follow-up visits for 1 year.
  End-of-Study Visit:
  About 30 days after the study stops or you decide to withdraw from the study, you will have a physical exam and you will be asked about any side effects you may have and if you have had a change in medication. If you cannot come to MD Anderson for this visit, a member of the study staff will call you. This call should last about 10 minutes.
  Follow-Up:
  About every 12 weeks for up to 1 year, you will be asked about any side effects you may have had and your medical history will be recorded. If you cannot come to MD Anderson for this visit, a member of the study staff will call you. This call should last about 10 minutes.
  After 1 year of follow up, you will continue to have follow-up as part of your standard of care (collecting information about any side effects you may have and your medical history). If the follow-up is at another hospital, the information about your medical history, physical exam, lab tests, PET, MRI, or CT scans will be sent to MD Anderson for review.

Eligibility: Inclusion Criteria:
  1. Pathologically confirmed diagnosis of cancer
  2. Progressive disease via RECIST 1.1 on prior study or standard of care therapy utilizing an immunotherapy agent OR a clinical status that requires salvage radiation treatment (e.g.: palliative RT) at the discretion of treating Physician and/or PI.
  3. Be within 6 months (+/-1 week) between last dose of an immunotherapy agent and study enrollment. *a. Patients may continue with maintenance immunotherapy as part of standard of care therapy while receiving radiation.
  4. Have at least one site of metastatic disease amenable to radiation. All lesions amenable to radiation may be irradiated at the discretion of treating Radiation Oncologist, depending on the location, size and number of lesions.
  5. Be willing and able to provide written informed consent/assent for the trial.
  6. Be >/= 18 years of age on day of signing informed consent.
  7. Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale.
  8. Female subject of childbearing potential should have a negative urine or serum pregnancy within 28 days prior to first fraction of radiation. *Note: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  9. We will allow prior radiation to other sites, with no washout period, prior to study entry as long as the high dose regions of the prior and proposed radiation fields do not overlap or it can overlap, as long as the area being treated is getting low dose radiation; this can be done alone or in combination with high dose to a previously un-irradiated area.
  Exclusion Criteria:
  1. Has a diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy.
  2. Has had prior radiation therapy within the past 3 months where the high dose area of the prior radiation would overlap with the high dose area of the intended radiation based on the judgment of the treating radiation oncologist.
  3. Has not recovered (i.e., </= Grade 1 or at baseline) from adverse events due to a previous treatment. *Note: Subjects with permanent </= Grade 2 toxicities (e.g. neuropathy) or toxicities corrected through routine medical management (e.g. thyroid replacement for hypothyroidism) are an exception to this criterion and may qualify for the study. **Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. ***Note: Subjects with asymptomatic </= Grade 2 laboratory or dermatologic abnormalities are an exception to this criterion and may qualify for the study pending the judgment of the treating radiation oncologist.
  4. Has an active infection requiring intravenous systemic therapy or hospital admission.
  5. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  6. Is pregnant or expecting to conceive or within the projected duration of the trial, starting with the screening visit through 60 days after the last fraction of radiation.

Relevance to patient case: not relevant