RecruitingPhase 2NCT02710253

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

Phase II Trial of Salvage Radiation Therapy to Induce Systemic Disease Regression After Progression on Systemic Immunotherapy

Sponsor

M.D. Anderson Cancer Center

Enrollment

230 participants

Start Date

May 25, 2016

Study Type

INTERVENTIONAL

Conditions

Metastatic Malignant Solid Neoplasm Hematopoietic and Lymphoid Cell Neoplasm

Summary

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 (metastatic) 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.

Eligibility

Min Age: 18 Years

Inclusion Criteria12

Pathologically confirmed diagnosis of cancer.
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.
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.
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-for the trial.
Be ≥ 18 years of age on day of signing informed consent.
Have a performance status of 0-2 on the ECOG performance scale.
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.
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.
Non-English speakers may enroll on the protocol.

Exclusion Criteria10

The subject must be excluded from participating in the trial if the subject:
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 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.
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.