ECI301 and Radiation for Advanced or Metastatic Cancer
Condition: Cancer; Neoplasm Metastasis; Radiation Oncology; Neoplasm; Metastasis
MeSH terms: Neoplasms; Neoplasm Metastasis; Neoplasms, Second Primary
Intervention: Radiation Therapy; ECI301
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Metastasis; Cancer; Radiation Therapy; Locally Advanced; Palliation; Metastatic Cancer

Summary:

      Background:

      - ECI301 is a drug that may help make cancer cells more visible to the immune system after
      radiation. The drug may also help the immune system destroy the cancer at sites that have not
      received radiation therapy. Researchers want to study ECI301 in people with advanced cancer
      or cancer that has spread in the body (metastatic).

      Objectives:

      - To test ECI301 with radiation therapy for advanced or metastatic cancer.

      Eligibility:

      - People at least 18 years of age with either metastatic or advanced cancer that may benefit
      from radiation therapy.

      Design:

        -  Participants will be screened with a medical history and physical exam. They will also
           have blood and urine tests, and imaging studies.

        -  All participants will have radiation therapy 5 days a week for 2 weeks.

        -  They will have different doses of ECI301 to test its safety and effectiveness. ECI301
           will be given in a vein during the second week of radiation therapy. Frequent blood
           tests and imaging studies will monitor the treatment.

        -  After participants have ECI301, tumor samples may be taken from the site that had
           radiation and another site that did not have radiation.

        -  Follow-up visits will include blood tests and imaging studies.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

        2.1.1.1 Age greater than or equal to18 years.

        2.1.1.2 Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
        2.

        2.1.1.3 Life expectancy of greater than 3 months

        2.1.1.4 Histologically confirmed cancer

        2.1.1.5 Extracranial metastatic cancer or locally advanced cancer for which palliative
        radiotherapeutic management would be appropriate (no more than two sites will be treated on
        this trial)

        2.1.1.6 Patients must have measurable or evaluable disease at the site(s) requiring
        radiation

        2.1.1.7 Adequate marrow and organ function defined as

          -  absolute neutrophil count (ANC) > 1.5 times 10(9)/L,

          -  platelet count > 100 times 10(9),

          -  hemoglobin >9 g/L.

          -  creatinine clearance greater than or equal to 60 mL/min/1.73 m(2) for patients with
             creatinine levels above institutional normal

          -  serum bilirubin <1.5 times upper limit reference range (ULRR),

          -  alanine aminotransferase (ALT), aspartate aminotransferase (AST), or

        alkaline phosphatase (ALP) <2.5 times the ULRR (<5 times the ULRR in the presence

        of liver metastases)

        2.1.1.8 Female patients of childbearing potential must either be surgically sterile to
        prevent pregnancy, be at least 1-year post-menopausal, or have had no menses for 12 months,
        or agree to use reliable methods of contraception (oral contraceptives, barrier methods,
        approved contraceptive implant, long-term injectable contraception, copper banded
        intrauterine device, tubal ligation or abstinence) from time of screening until 4 weeks
        after discontinuing study treatment. It is not known whether ECI301 has the capacity to
        induce hepatic enzymes so hormonal contraceptives should be combined with a barrier method
        of contraception.

        2.1.1.9 Male patients must agree to use barrier contraception (i.e. condoms) and refrain
        from donating sperm from the start of dosing until 16 weeks after discontinuing study
        treatment. If male patients wish to father children, they should be advised to arrange for
        freezing of sperm prior to the start of study treatment.

        EXCLUSION CRITERIA:

        2.1.2.1 Pregnant or lactating females

        2.1.2.2 Contraindications to radiotherapy (i.e. prior radiotherapy to the intended
        treatment site)

        2.1.2.3 Untreated or previously treated but progressive intracranial metastases (Patients
        with previously treated intracranial metastases should have no clinical evidence of
        progression and be at least 4 weeks from therapy for intracranial metastases)

        2.1.2.4 Need for emergent radiotherapy (defined as need for radiotherapy within 24 hours of
        consultation at the judgment of the treating radiation oncologist)

        2.1.2.5 Active treatment with immunosuppressive therapy and subjects taking systemic
        corticosteroid therapy for any reason including replacement therapy for hypoadrenalism

        2.1.2.6 Chemotherapy, radiation therapy, Tamoxifen or investigational therapy during the 4
        weeks prior to initiation of protocol therapy

        2.1.2.7 History of rheumatoid arthritis, systemic lupus erythematosus, Sjogren's disease,
        sarcoidosis, vasculitis, polymyositis, temporal arteritis or any other autoimmune disease

        2.1.2.8 History of organ transplant

        2.1.2.9 Human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C positivity

        2.1.2.10 Uncontrolled intercurrent illness including, but not limited to, ongoing or active
        infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
        arrhythmia, or psychiatric illness/social situations that would limit compliance with study
        requirements

        2.1.2.11 Use of excluded immune modulating medications within 4 weeks prior to protocol
        therapy, or requirement for concurrent use.