Efficacy Study of Recombinant Adenovirus for Non Muscle Invasive Bladder Cancer

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Brief Title

Efficacy Study of Recombinant Adenovirus for Non Muscle Invasive Bladder Cancer

Official Title

An Integrated Phase II/III, Open Label, Randomized and Controlled Study of the Safety and Efficacy of CG0070 Adenovirus Vector Expressing GM-CSF in Patients With NMIBC With Carcinoma In Situ Disease Who Have Failed BCG

Brief Summary

      The use of a designed viral vector that can destroy cancer cells while leaving normal cells
      largely unharmed. The virus also stimulates an immunological response by producing a special
      factor (GM-CSF) to attract and promote the development of dendritic and T effector cells. It
      forms the hypothesis that this regimen may be used for people who have failed current forms
      of treatment and are recommended for cystectomy. It is with hope that this novel therapy will
      be able to delay or potentially avoid cystectomy for this patient population. Bladder
      instillation of this agent causes little long lasting side effects and may drastically
      improve the stimulation of the immune system for local cancer cell death as well as
      destroying those tumor cells that may have travelled to regional lymph nodes or distant
      organs.
    

Detailed Description

      After the phase I/II CG0070 trial review, it became apparent that the use of CG0070 oncolytic
      vaccine as an intravesical agent for oncolytic lysis of tumor cells, together with the
      transcription of GM-CSF on site, may have distinct advantages. This first study showed
      excellent tumor response rates of 48-77% depending on the dose schedule administered. All of
      these patients had residual non-muscle invasive bladder cancer who have previously failed BCG
      therapy at the time of treatment.

      With the addition of a transduction agent such as DDM, the intravesical instillation of
      CG0070 enabled uniform distribution of viral particles and exposure to the tumor during those
      30-60 minutes instillations as contrast to the intra-tumor injection, intra-arterial or
      intravenous injection of viral particles in other oncolytic viral trials. Some or most of
      these delivering methodologies have obvious intrinsic imperfections and potential toxicity.
      This unique opportunity of an relatively easy intravesical tumor exposure is difficult to
      duplicate in other solid tumor models.

      The replication of CG0070 in the majority of patients during the first phase I/II trial
      indicated tumor lysis with release of tumor specific or tumor associated antigens that have
      been stably expressed, in abundant quantities during tumor cell death. Release of tumor
      antigens have been the key elements, together with sufficient on-site GM-CSF, in stimulating
      strong cross-presentation and confirmation signals to the antigen presenting cells such as
      dendritic cells interacting with CD4+ and CD8+ T cells. This concept of a "real time" vaccine
      like regimen is expected to compare favorably with other forms of cancer immunotherapy
      treatment such as BCG in this patient population.

      It is with this thought that CG0070 may find a success in this setting because of a
      reasonably and proven complete response rate in residual and failed BCG bladder cancer
      patients in the first phase I/II study (some cases with only one instillation). Of importance
      as well, is the demonstration in the study data of a strong GM-CSF expression during its
      replication phase. Those patients with carcinoma in situ disease and those with RB pathway
      dysfunction were particularly responsive.

      It is therefore, desirable to formulate a protocol to encompass the specialty of this
      oncolytic vaccine and the unique intravesical delivery to prove the efficacy by a randomized
      controlled study. This opportunity allows a study on the CG0070's beneficial effects, if any,
      on the standard of care for carcinoma in situ non muscle invasive bladder cancer patients
      after they failed BCG therapy. The prognosis of this group presently depends mainly on early
      radical cystectomy, which carries a high morbidity and decrease of quality of life generally
      viewed as unacceptable for this group of older patients.
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Complete Response Proportion (CR)

Secondary Outcome

 Progression rate to muscle invasive disease

Condition

Transitional Cell Carcinoma

Intervention

CG0070 Adenovirus Vector

Study Arms / Comparison Groups

 CG0070 oncolytic virus
Description:  Interventions: CG0070 oncolytic virus intravesical instillations weekly X6 with each instillation lasting 45 minutes after prior transduction agent of DDM intravesically for 15 minutes

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

Biological

Estimated Enrollment

22

Start Date

March 2014

Completion Date

June 2016

Primary Completion Date

June 2016

Eligibility Criteria

        Inclusion Criteria:

          1. Patients must be considered high risk, with pathologically confirmed high grade
             disease (HG) WHO 2004

          2. Patients must have pathologically-proven unresectable, primary, secondary or
             concurrent carcinoma in situ disease, defined by having either Ta and/or T1 with CIS,
             or CIS

          3. Patients must have no evidence of muscle invasive disease

          4. Patient need to sign a specific informed consent acknowledging that a delay of
             cystectomy may lead to an increase chance of progression and/or metastasis with
             serious or sometimes fatal consequences.

          5. Patients must have received at least two or more prior courses of intravesical
             therapy. BCG must have been one of the prior therapies administered. Patients can have
             either failed BCG induction therapy within a six month period or have been
             successfully treated with BCG, but subsequently found to have recurrence. The standard
             course of intravesical therapy must include six weekly treatments (allowable range of
             instillations per course is 4-9). The second course of BCG can consist of three weekly
             treatments

          6. 18 years of age or older

          7. Residual disease at accrual

          8. Pathologically diagnosed transitional cell (urothelial) bladder cancer (further
             details in 10.) patients where radical cystectomy with curative intent is indicated
             for superficial bladder cancer that is resistant to treatment.

          9. Patients must be able to enter into the study within five weeks of their most recent
             diagnostic procedure, which is usually a diagnostic biopsy, a transurethral resection
             of bladder tumor (TURBT) procedure or other diagnostic scanning such as CT and PET
             procedures.

         10. Histopathologically confirmed, transitional cell (urothelial) carcinoma. Urothelial
             tumors with mixed histology (but with <50% variant) are eligible.

         11. No evidence of urethral or renal pelvis TCC by upper tract radiological imaging (e.g.,
             intravenous pyelogram, CT urogram, or retrograde pyelogram) within the past 2 years.

         12. Eastern Cooperative Oncology Group (ECOG) performance status <2.

         13. Not pregnant or lactating

         14. Patients with child bearing potential must agree to use adequate contraception

         15. Agree to study specific informed consent and HIPAA authorization for release of
             personal health information

         16. Adequate baseline CBC, renal and hepatic function. Renal parameters as detailed above.
             Absolute lymphocyte count ≥ 1,000/μL before all doses of CG0070

         17. Patient to provide a tumor specimen for determination of RB pathway status

        Exclusion Criteria:

          1. Previous systemic chemotherapy or radiation for bladder cancer. Note: Prior
             immunotherapy or intravesical (administered within the bladder) chemotherapy for
             superficial disease is acceptable

          2. No bladder cancer residual disease, such as patients that are rendered disease free by
             TURBT

          3. History of anaphylactic reaction following exposure to humanized or human therapeutic
             monoclonal antibodies, hypersensitivity to GM-CSF or yeast derived products,
             clinically meaningful allergic reactions or any known hypersensitivity or prior
             reaction to any of the formulation excipients in the study drugs.

          4. Known infection with HIV, HBV or HCV.

          5. Anticipated use of chemotherapy, radiotherapy, or other immunotherapy not specified in
             the study protocol while on study

          6. Any underlying medical condition that, in the Investigator's opinion, will make the
             administration of study vaccine hazardous to the patient, would obscure the
             interpretation of adverse events, or surgical resection. Anticipated use of
             chemotherapy, radiotherapy, or other immunotherapy not specified in the study protocol
             while on study

          7. Systemic treatment on any investigational clinical trial within 28 days prior to
             registration.

          8. Concurrent treatment with immunosuppressive or immunomodulatory agents, including any
             systemic steroid (exception: inhaled or topically applied steroids, and acute and
             chronic standard dose NSAIDs, are permitted). Use of a short course (i.e., ≤ 1 day) of
             a glucocorticoid is acceptable to prevent a reaction to the IV contrast used for CT
             scans.

          9. Immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or
             tacrolimus within 3 months of study entry.

         10. History of prior experimental cancer vaccine treatment (e.g., dendritic cell therapy,
             heat shock vaccine)

         11. History of partial cystectomy in the setting of bladder cancer primary tumor.

         12. History of anaphylactic reaction following exposure to humanized or human therapeutic
             monoclonal antibodies, hypersensitivity to GM-CSF or yeast derived products,
             clinically meaningful allergic reactions or any known hypersensitivity or prior
             reaction to any of the formulation excipients in the study drugs.

         13. History of stage III or greater cancer, excluding urothelial cancer. Basal or squamous
             cell skin cancers must have been adequately treated and the subject must be
             disease-free at the time of registration. Subjects with a history of stage I or II
             cancer, must have been adequately treated and have been disease-free for ≥ 3 years at
             the time of registration.

         14. Concomitant active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis,
             autoimmune thyroid disease, uveitis)

         15. Progressive viral or bacterial infection

         16. All infections must be resolved and the patient must remain afebrile for seven days
             without antibiotics prior to being placed on study

         17. Any underlying medical condition that, in the Investigator's opinion, will make the
             administration of study vaccine hazardous to the patient, would obscure the
             interpretation of adverse events, or not permit adequate surgical resection.

         18. Unwilling or unable to comply with the protocol or cooperate fully with the
             investigator and site personnel
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Alex W Yeung, MBBS, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01438112

Organization ID

12154


Responsible Party

Sponsor

Study Sponsor

CG Oncology, Inc.


Study Sponsor

Alex W Yeung, MBBS, Study Chair, CG Oncology, Inc.


Verification Date

April 2021