Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma

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Brief Title

Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma

Official Title

A Pilot Clinical Trial of Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma

Brief Summary

      Background:

      Advanced urothelial cancer has no cure. But only a few chemotherapy drugs have been tested
      for it. The Co-eXpression ExtrapolatioN (COXEN) model predicts if cells respond to treatment.
      It may also help determine which drugs fight urothelial cancer based on the characteristics
      of a tumor. Researchers want to test if this model can choose the best therapy for advanced
      urothelial cancer within 3 weeks and how tumors respond to the next best therapy.

      Objective:

      To test if the COXEN model can choose the best therapy for advanced urothelial cancer within
      3 weeks.

      Eligibility:

      People ages 18 and older whose urothelial cancer has spread after at least 1 line of
      chemotherapy

      Design:

      Participants will be screened with medical history, physical exam, blood and urine tests, and
      tumor scans.

      Participants will provide a tumor sample from a previous surgery and a new biopsy. A needle
      will remove a small piece of tumor.

      Participants will repeat screening tests, plus have an electrocardiogram (EKG) and scan. For
      the scan, they will get an injection of radioactive drug. They will lie in a machine that
      takes pictures.

      Participants will take the drugs assigned by the COXEN model. They will have visits every 2-3
      weeks. These will include blood and urine tests.

      Participants will have tumor scans every 8-9 weeks.

      Participants may have another biopsy.

      Participants will take the drugs until they can't tolerate the side effects or their cancer
      worsens. They may be assigned to a second COXEN therapy.

      Participants will have a follow-up visit 4-5 weeks after their last drug dose.

      Participants will be contacted by phone every few months until death.
    

Detailed Description

      Background:

        -  Patients presenting de novo with metastatic bladder cancer, or developing visceral
           metastatic disease after local treatment, are incurable with currently available
           therapeutic modalities.

        -  Only a small number of chemotherapeutic agents have been tested and very few have some
           single agent activity in the treatment of metastatic urothelial carcinoma. However most
           (>100) Food and Drug Administration (FDA) approved anticancer agents have yet to be
           tested in this disease.

        -  Novel approaches to the development of genomic predictors of chemosensitivity that do
           not require clinical trials for their identification are urgently needed in order to
           identify agents that are clinically effective when either repurposed or discovered de
           novo specifically for urothelial carcinoma. Such repurposing of an FDA approved
           anticancer agent in order to advance therapy from one cancer to another would require
           only minimal clinical development, saving billions of dollars and reducing the time
           required to reach routine clinical practice.

        -  Our established extramural-intramural National Cancer Institute (NCI) collaboration
           pulls together significant expertise in biomarker development and clinical trial design
           in bladder cancer. The innovation of this group lies not only in the novel scientific
           approaches i.e. CoeXpression ExtrapolatioN (COXEN) under investigation, but also in the
           successful creation of a cohesive multi-institutional research collaboration dedicated
           to improved clinical outcomes in bladder cancer patients.

        -  COXEN uses molecular profiles as a Rosetta Stone for translating drug sensitivities of
           one set of cancers into predictions for another completely independent set of cell lines
           or human tumors. The COXEN methodology has been scrutinized and deemed methodologically
           sound by peer review. The ability of COXEN to predict drug effectiveness in patients a
           priori, from purely in vitro assays, is unique as no other tool currently either in
           practice or in development provides similar results.

      Objectives:

      - To determine the feasibility of using the Co-eXpression ExtrapolatioN (COXEN) model in
      making a real-time treatment decision (within 3 weeks) in patients with advanced urothelial
      carcinoma.

      Eligibility:

        -  Patients must have a histologically confirmed diagnosis of metastatic, progressive
           urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.

        -  Patients must have progressive metastatic disease defined as new or progressive lesions
           on cross-sectional imaging.

        -  Patients must have at least:

             -  One measurable site of disease (according to Response Evaluation Criteria in Solid
                Tumors (RECIST) criteria)

             -  Or, appearance of one new bone lesion

        -  Patients must have been previously treated, as defined by treatment with at least one
           prior cytotoxic chemotherapy regimen or agent. Patients may have received any number of
           prior cytotoxic agents.

        -  Archival tumor tissue must be available for enrollment.

        -  Tumor amenable to biopsy will be mandatory for this study.

        -  18 years of age or older

        -  Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >60%)

      Design:

        -  This will be a pilot single-arm, open-label study using the COXEN score to select the
           best next therapy from a list of 75 FDA approved anti-neoplastic drugs, in patients with
           metastatic bladder cancer who have progressed despite treatment with cytotoxic
           chemotherapy. Combinations of the listed agents may also be utilized provided that phase
           1 data are available.

        -  The COXEN algorithm requires a multi-step process (pathology, tissue processing,
           messenger ribonucleic acid (mRNA) profiling, bioinformatics, etc.) and is potentially
           labor intensive and time intensive.

        -  Given the disease state of patients eligible for this protocol, using this algorithm to
           select a treatment would only be a worthwhile process to undertake if it can be
           demonstrated that a very high fraction of patients are likely to obtain the benefit from
           the procedure.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Percentage of Participants Who Enrolled and Underwent a Biopsy Who Went on to Receive Treatment Within 21 Days

Secondary Outcome

 Progression Free Survival

Condition

Urothelial Carcinoma

Intervention

75 approved agents

Study Arms / Comparison Groups

 Treatment Regimen
Description:  Treatment regimen selected by CO eXpression ExtrapolatioN (COXEN) model

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

8

Start Date

March 27, 2017

Completion Date

October 23, 2019

Primary Completion Date

October 23, 2019

Eligibility Criteria

        -  INCLUSION CRITERIA:

          -  Patients must have a histologically confirmed diagnosis of metastatic, progressive
             urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.

          -  Patients must have progressive metastatic disease defined as new or progressive
             lesions on cross-sectional imaging.

          -  Patients must have at least:

               -  One measurable site of disease (according to Response Evaluation Criteria in
                  Solid Tumors (RECIST) criteria), defined as at least one lesion that can be
                  accurately measured in at least one dimension (longest diameter to be recorded
                  for non-nodal lesions and short axis for nodal lesions) as more than or equal to
                  20 mm with conventional techniques or as less than or equal to 10 mm with spiral
                  computed tomography (CT) scan.

               -  Or, appearance of one new bone lesion

          -  Patients must have been previously treated with at least one prior cytotoxic
             chemotherapy regimen or agent. Patients may have received any number of prior
             cytotoxic agents.

          -  Archival tumor tissue must be available for enrollment.

          -  Tumor amenable to biopsy will be mandatory for this study.

          -  Age more than or equal to 18 years. Eastern Cooperative Oncology Group (ECOG)
             performance status less than or equal to 2 (Karnofsky more than or equal to 60%,).

          -  Patients must have normal organ and marrow function as defined below:

               -  hemoglobin more than or equal to 9 g/dL

               -  leukocytes more than or equal to 3,000/mcL

               -  absolute neutrophil count more than or equal to 1,200/mcL

               -  platelets more than or equal to 75,000/mcL

               -  total bilirubin within normal institutional limits

               -  Aspartate aminotransferase (AST)/Serum glutamic oxaloacetic transaminase
                  (SGOT)/Alanine aminotransferase (ALT)/Serum glutamic pyruvic transaminase(SGPT)
                  less than or equal to 2.5 X institutional upper limit of normal

               -  creatinine 1.5 x the normal institutional limits

        OR

        --creatinine clearance more than or equal to 40 mL/min/1.73 m^2

          -  Because many of the therapeutic agents used in this trial are known to be teratogenic,
             women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for
             the duration of study participation. Should a woman become pregnant or suspect she is
             pregnant while she or her partner is participating in this study, she should inform
             her treating physician immediately.

          -  Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral
             therapy may be eligible if there are no pharmacokinetic interactions with the agents
             used on the study, stable on Chimeric antigen receptor T-cell (CART) therapy and
             cluster of differentiation 4 (CD4) is >200 and viral load is undetectable.

          -  Ability of subject to understand and the willingness to sign a written informed
             consent document.

        EXCLUSION CRITERIA:

          -  The patient has received cytotoxic chemotherapy (including investigational cytotoxic
             chemotherapy) within 3 weeks or biologic agents (e.g., cytokines or antibodies) within
             4 weeks prior to study enrollment.

          -  Patients who are receiving any investigational agents.

          -  Patients with known brain metastases should be excluded from this clinical trial
             because of their poor prognosis and because they often develop progressive neurologic
             dysfunction that would confound the evaluation of neurologic and other adverse events.
             Patients with brain metastases that are stable after more than or equal to 1 year
             after primary surgery or radiation will not be excluded.

          -  The subject has not recovered to baseline or Common Terminology Criteria for Adverse
             Events (CTCAE) less than or equal to Grade 1 from toxicity due to all prior therapies
             except alopecia and other non-clinically significant adverse events (AEs(.

          -  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.

          -  Patients who are Hepatitis B or C positive.

          -  Pregnant women are excluded from this study because the agents used in the study have
             the potential for teratogenic or abortifacient effects. Because there is an unknown
             but potential risk for adverse events in nursing infants secondary to treatment of the
             mother with these agents, breastfeeding should be discontinued if the mother is
             treated with these agents. These potential risks may also apply to other agents used
             in this study.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Andrea B Apolo, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02788201

Organization ID

160121

Secondary IDs

16-C-0121

Responsible Party

Principal Investigator

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Andrea B Apolo, M.D., Principal Investigator, National Cancer Institute (NCI)


Verification Date

October 2020