Study of Intratumoral REOLYSIN® in Combination With Gemcitabine and Cisplatin as Neoadjuvant Therapy in Muscle-invasive Transitional Cell Carcinoma of the Bladder

NCT02723838 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: REO 023
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to investigate the safety and efficacy of intratumoral REOLYSIN® therapy alone and in combination with standard neoadjuvant gemcitabine and cisplatin in muscle-invasive bladder cancer.

Conditions

Muscle-invasive Transitional Cell Carcinoma of the Bladder

Keywords

Bladder; Cancer; REOLYSIN®; Gemcitabine; Cisplatin; Reovirus; Oncolytic virus

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events

  Nature, frequency, severity and timing of Adverse Events.

  During treatment and up to 28 days after treatment

• Pre- and post-treatment biopsies will be evaluated for tumor viability, percentage of necrosis, reovirus replication and tumor infiltration of immune cells and expression of PD-1 and PD-L1

  Assessed at surgery conducted following 3 3-week study treatment cycles

Secondary Outcomes (2)

• Time to Treatment Failure (TTF)

  By medical chart review until disease reoccurrence or 2 years from surgery, whichever occurs first first.

• Disease Free Survival (DFS)

  By medical chart review until disease reoccurrence or death or 2 years from surgery, whichever occurs first.

Interventions

REOLYSIN® BIOLOGICAL

3 cycles (each cycle = 21 days). Cohort 1: 3x10E10 TCID50 intratumoral via cystoscopy on Day 1 of each cycle. Cohort 2: 3x10E10 TCID50 intratumoral via cystoscopy on Day 2 of each cycle.

Gemcitabine DRUG

3 cycles (each cycle = 21 days). Cohort 1: 1000mg/m2 intravenously on Day 2 and Day 9 of Cycle 2 and Cycle 3. Cohort 2: 1000mg/m2 intravenously on Day 1 and Day 8 of each cycle.

Cisplatin DRUG

3 cycles (each cycle = 21 days). Cohort 1: 70 mg/m2 intravenously on Day 2 of Cycle 2 and Cycle 3. Cohort 2: 70 mg/m2 intravenously on Day 1 of each cycle.

Eligibility Criteria

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

You may qualify if:

• Histologically and clinically confirmed muscle-invasive bladder cancer (T2-4) with or without pelvic lymph nodes involvement (N1-2) in Stage III and IV (M0).
• ECOG performance status ≤2.
• Adequate liver function with a bilirubin within normal limits. Transaminases up to 3 x ULN (Grade 1) and alkaline phosphatase may be up to 2.5 x ULN (Grade 1).
• Adequate bone marrow function, as defined by neutrophils count of ≥1,500/mm3, and platelet count ≥100,000/ mm3.
• Adequate renal function (serum creatinine ≤1.5 times the ULN).
• Negative pregnancy test and reliable and appropriate contraceptive method during the study for a woman of childbearing potential. All female patients of childbearing age and all male patients with partners of childbearing age should use a reliable method of contraception, such as the barrier method, throughout the study and for 60 days after last treatment.
• Informed of the investigational nature of this study and must sign a written informed consent in accordance with institutional and federal guidelines.

You may not qualify if:

• Received any prior therapy for invasive bladder cancer including surgery, radiation therapy, chemotherapy or any other systemic anti-cancer therapy (prior intravesical therapy for non-invasive bladder cancer is acceptable including intravesical BCG and/or mitomycin and interferon).
• Evidence of lymph nodes or other metastatic disease beyond the pelvis (N3 and/or M1).
• Pre-existing immunosuppressive or connective tissue disorders that require immune suppressive drugs.
• History of HIV or active hepatitis.
• Any serious concurrent illness including; but not limited to, unstable angina pectoris, uncompensated congestive cardiac failure; myocardial infarct in the previous 6 months; cardiac arrhythmias or psychiatric illness that would limit compliance with study requirements.
• Pregnant or lactating.
• A history of hypersensitivity to gemcitabine and cisplatin or any component of the formulation.
• A prior malignancy, other than non-melanoma skin cancer, unless they have completed therapy at least 5 years prior to start of study and have no evidence of recurrent or residual disease.
• Unwilling or unable to sign informed consent document.
• In social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• Oncolytics Biotech: lead

MeSH Terms

Conditions

Neoplasms

Interventions

reolysin; Gemcitabine; Cisplatin

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: March 31, 2016
• Study Start: February 28, 2017
• Primary Completion: September 30, 2017
• Study Completion: February 28, 2018
• Last Updated: March 7, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share