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

Study Purpose

This phase II trial studies the side effects and best dose of radiation therapy and to see how well it works in treating patients with cancer that has spread to other places in the body or has increased in size after being treated with immunotherapy. Giving radiation therapy may help to control the cancer after the disease has gotten worse after receiving immunotherapy in patients with cancer that has spread to the other places in the body.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Pathologically confirmed diagnosis of cancer.
  • - Progressive disease via Response Evaluation Criteria in Solid Tumors version 1.1 (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 radiation therapy [RT]) at the discretion of treating physician and/or principal investigator (PI) - Be within 6 months (+/-1 week) between last dose of an immunotherapy agent and study enrollment.
  • - Patients may continue with maintenance immunotherapy as part of standard of care therapy while receiving radiation.
  • - 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.
  • - Be willing and able to provide written informed consent/assent for the trial.
  • - Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale.
  • - Female subject of childbearing potential should have a negative urine or serum pregnancy within 28 days prior to study registration up to the first fraction of radiation; - Note: if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • - 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:

  • - Has a diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy.
  • - 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.
  • - 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.
  • - Has an active infection requiring intravenous systemic therapy or hospital admission.
  • - Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02710253
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

M.D. Anderson Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

James Welsh
Principal Investigator Affiliation M.D. Anderson Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Metastatic Malignant Neoplasm
Study Website: View Trial Website
Additional Details

PRIMARY OBJECTIVES:

  • I. To identify immunotherapy-based treatments where salvage radiation produces systemic disease control after initial progressive disease.
  • II. To identify immunotherapy-based treatments where salvage radiation produces a high rate of treatment-related toxicities.
SECONDARY OBJECTIVES:
  • I. To determine the frequency of systemic disease control (objective response or stable disease) after salvage radiation following progression on immunotherapy among all patients and within each treatment group.
  • II. Determine the frequency of dose limiting toxicities (DLTs) with salvage radiation after progression on treatment with an immunotherapy agent among all patients and within each treatment group.
  • III. To determine the rate of systemic objective response among all patients and within each treatment group among all patients and within each treatment group.
  • IV. To determine the duration of response in patients who achieve disease control among all patients and within each treatment group.
  • V. To determine the overall survival after salvage radiation among all patients and within each treatment group.
  • VI. To determine the systemic progression free survival after salvage radiation among all patients and within each treatment group.
OUTLINE: Patients undergo either 4 fractions of stereotactic body radiation therapy (SBRT) or 5-15 fractions of external beam radiation therapy (EBRT) to any site of metastatic disease daily for any time between 4 days and 3 weeks as determined by the treating radiation oncologist. Patients with at least stable disease (SD) after the second imaging evaluation may undergo additional SBRT in 4 fractions or EBRT in 3 fractions. After completion of study treatment, patients are followed up at 30 days, then every 12 weeks for up to 1 year.

Arms & Interventions

Arms

Experimental: Treatment (SBRT or EBRT)

Patients undergo either 4 fractions of SBRT or 5-15 fractions of EBRT to any site of metastatic disease daily for any time between 4 days and 3 weeks as determined by the treating radiation oncologist. Patients with at least SD after the second imaging evaluation may undergo additional SBRT in 4 fractions or EBRT in 3 fractions.

Interventions

Radiation: - External Beam Radiation Therapy

Undergo EBRT

Other: - Laboratory Biomarker Analysis

Correlative studies

Radiation: - Stereotactic Body Radiation Therapy

Undergo SBRT

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

M D Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

M D Anderson Cancer Center

Houston, Texas, 77030

Site Contact

James Welsh

jwelsh@mdanderson.org

713-563-2300

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