Clinical Trials Logo

Clinical Trial Summary

This study is designed to assess the efficacy and safety of DTA-H19/PEI given as six intravesical instillations of 20 mg of plasmid DNA complexed with PEI into the bladder of patients with intermediate risk superficial bladder cancer [recurrent stages Ta (low or high grade)and T1, (low grade) transitional cell carcinoma (TCC)] who have failed prior intravesical therapies including either Bacillus Calmette-Guérin (BCG) or chemotherapy. The primary efficacy objective is to determine the effect of DTA-H19/PEI on the prevention of new tumors after the induction course of 6 weekly intravesical administrations of investigational product assessed 8 to 10 weeks after the start of treatment. Secondary objectives include assessing the ablative effect of DTA-H19/PEI on a marker tumor, safety assessed by the incidence and severity of adverse events, determining the long-term (46 weeks) continued rates of absence of bladder cancer, and time to tumor recurrence in those patients who had a complete response (CR) after the induction course.


Clinical Trial Description

DTA-H19, is a doubled stranded DNA plasmid that carries the gene for the diphtheria toxin A (DT-A) chain under the regulation of the H19 promoter sequence. This is a Patient-Oriented, Targeted Therapy as DT-A chain expression is triggered by the presence of H19 transcription factors that are upregulated in tumor cells. The selective initiation of toxin expression results in selective tumor cell destruction via inhibition of protein synthesis in the tumor cell, enabling highly targeted cancer treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00595088
Study type Interventional
Source Anchiano Therapeutics Israel Ltd.
Contact
Status Completed
Phase Phase 2
Start date January 2008
Completion date January 2013

See also
  Status Clinical Trial Phase
Completed NCT01687244 - Intravesical Administration of rAd-IFN/Syn3 in Patients With BCG-Refractory or Relapsed Bladder Cancer Phase 2
Completed NCT02773849 - ADSTILADRIN (=INSTILADRIN) in Patients With High Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) Phase 3
Recruiting NCT03379909 - Phase II Study of Oral Metformin for Intravesical Treatment of Non-muscle-invasive Bladder Cancer Phase 2
Completed NCT00782587 - Study of Immediate Post-Operative Intravesical Instillation of Chemophase® in Patients With Superficial Bladder Cancer Phase 1
Recruiting NCT05084586 - Comparison of the Efficacy and Safety of Continuous and Single-Dose Intravesical Epirubicin Instillation N/A
Recruiting NCT03121768 - A New Prognostic Model for Predicting the Outcome of Patients With Non-muscle Invasive Bladder Cancer (NMIBC) N/A
Completed NCT03091764 - Evaluation of a Patient-Reported Symptom Index for NMIBC
Completed NCT01939756 - Intravesical Natural Baobab Oil in the Management of BCG-induced Lower Urinary Tract Symptoms Phase 1/Phase 2
Completed NCT02007005 - Maximum Tolerable Concentration of abnobaVISCUM Fraxini Intravesically in Patients With Superficial Bladder Cancer Phase 1/Phase 2
Completed NCT01149174 - Preoperative Intravesical Electromotive Mitomycin-c for Primary Non-muscle Invasive Bladder Cancer Phase 3
Completed NCT00322699 - Sequential Whole Bladder Photodynamic Therapy (WBPDT) in the Management of Superficial Bladder Cancer Phase 1/Phase 2
Completed NCT00191711 - Intravesical Gemcitabine Instillation Followed by Transurethral Resection for the Treatment of Patients With Superficial Bladder Cancer at Low Risk. Phase 2
Completed NCT00192049 - A Randomized Study Comparing Single Agent Gemcitabine Intravesical Therapy Versus Mitomycin C in Patients With Intermediate Risk Superficial Bladder Cancer Phase 2
Recruiting NCT04752722 - LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve Phase 1/Phase 2
Recruiting NCT02106572 - Therapeutic Instillation of Mistletoe Phase 3
Completed NCT00734994 - Mitomycin C With Hyperthermia and Intravesical Mitomycin C to Treat Recurrent Bladder Cancer Phase 0