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Search / Trial NCT02710253

Salvage Radiation Therapy in Treating Patients With Metastatic Cancer That Has Progressed After Systemic Immunotherapy

Launched by M.D. ANDERSON CANCER CENTER · Mar 11, 2016

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring the use of radiation therapy in patients whose cancer has spread to other parts of the body or has worsened after receiving immunotherapy, a type of treatment that helps the immune system fight cancer. The goal is to find out the best dose of radiation and to understand its side effects, while also determining how effective it can be in controlling the cancer. This study is currently looking for participants aged 18 and older who have a confirmed diagnosis of cancer and have experienced disease progression after immunotherapy.

Eligible participants should have at least one area of cancer that can be treated with radiation and must be willing to provide informed consent to join the study. While receiving radiation, patients may continue their standard immunotherapy if needed. It’s important to note that those with certain medical conditions or recent treatments may not qualify. Participants can expect to undergo radiation therapy and will be monitored closely throughout the trial to assess their response and any side effects. This trial aims to provide valuable information that could help improve treatment options for patients with advanced cancer.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Pathologically confirmed diagnosis of cancer.
  • 2. Progressive disease via irRC 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. Previous progression of disease while on treatment of an immunotherapy agent or cell-based therapy.
  • 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-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 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.
  • 10. Non-English speakers may enroll on the protocol.
  • Exclusion Criteria:
  • The subject must be excluded from participating in the trial if the subject:
  • 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 hypothyroidisim) 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.

About M.D. Anderson Cancer Center

The University of Texas MD Anderson Cancer Center is a leading institution dedicated to cancer care, research, education, and prevention. As one of the world’s most respected cancer centers, MD Anderson focuses on innovative treatment approaches and groundbreaking clinical trials aimed at improving patient outcomes. With a multidisciplinary team of experts and state-of-the-art facilities, the center is committed to advancing cancer research and providing comprehensive, personalized care to patients. MD Anderson's clinical trials play a pivotal role in translating scientific discoveries into effective therapies, positioning the center at the forefront of cancer treatment and research.

Locations

Houston, Texas, United States

Sugar Land, Texas, United States

Conroe, Texas, United States

Houston, Texas, United States

League City, Texas, United States

Patients applied

0 patients applied

Trial Officials

James Welsh

Principal Investigator

M.D. Anderson Cancer Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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