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

NCT02710253 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2015-0936NCI-2016-00682
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Metastatic Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm

Outcome Measures

Primary Outcomes (3)

• Number of patients with stable disease

  To be evaluable for efficacy patients must receive at least one set of systemic imaging \>= 4 weeks after completion of radiation. For all control cohorts, efficacy will be evaluated based off of retrospective review of control patients. Corollary investigation will be conducted utilizing immune-related response criteria (ir-RC). Significance testing will assess differences in the frequency of disease control rate via Fisher Exact (if n =\< 20) or Chi-squared (if n \> 20) test.

  At 4 months

• Objective response (partial response or complete response)

  To be evaluable for efficacy patients must receive at least one set of systemic imaging \>= 4 weeks after completion of radiation. For all control cohorts, efficacy will be evaluated based off of retrospective review of control patients. Corollary investigation will be conducted utilizing ir-RC. Significance testing will assess differences in the frequency of objective response via Fisher exact (if n =\< 20) or Chi-squared (if n \> 20) test.

  Up to 1 year

• Incidence of adverse events

  Assessed with Common Terminology Criteria for Adverse Events version 4.0. To be evaluable for toxicity, patients must be on the trial for at least 8 weeks. For a toxicity to be considered a dose limiting toxicity, the toxicity must be grade 3+ non-dermatologic and non-laboratory, grade 4+ laboratory, or grade 4+ dermatologic. In addition the toxicity must meet the following criteria: 1. The toxicity must be immune-related. 2. The toxicity must be attributable to radiation. Exploratory analyses will compare specific treatment groups with the corresponding control group when available. Significance testing will assess differences in dose limiting toxicities via Fisher Exact (if n =\< 20) or Chi-Squared (if n \> 20) test.

  Up to 1 year

Secondary Outcomes (2)

• Overall survival

  Up to 1 year

• Progression free survival

  Up to 1 year

Study Arms (1)

Treatment (SBRT or EBRT)

EXPERIMENTAL

Patients undergo either 4, 5, or 10 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.

Radiation: External Beam Radiation Therapy; Other: Laboratory Biomarker Analysis; Radiation: Stereotactic Body Radiation Therapy

Interventions

External Beam Radiation Therapy RADIATION

Undergo EBRT

Also known as: Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy, External Beam RT, external radiation, External Radiation Therapy, external-beam radiation, Radiation, External Beam

Treatment (SBRT or EBRT)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (SBRT or EBRT)

Stereotactic Body Radiation Therapy RADIATION

Undergo SBRT

Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Treatment (SBRT or EBRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Artidis: collaborator

Study Sites (5)

MD Anderson in The Woodlands

Conroe, Texas, 77384, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MD Anderson West Houston

Houston, Texas, 77079, United States

Location

MD Anderson League City

League City, Texas, 77573, United States

Location

MD Anderson in Sugar Land

Sugar Land, Texas, 77478, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Hematologic Neoplasms; Neoplasm Metastasis

Interventions

Radiation; Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Phenomena; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• James Welsh

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: March 16, 2016
• Study Start: May 25, 2016
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

US (5)