Bladder Cancer Research

For enrollment information involving the following trials, please contact a member of our research support staff.

Genistein Therapy (GIBBS STUDY)

Surgical Resection (PK BUTTON)


rAd-IFN/Syn3 (Phase III)

Genistein Therapy (GIBBS Study)

Randomized Placebo-Controlled Clinical Trial of Genistein in Reducing the Toxicity and Improving the Efficacy of Intravescial Therapy

Inclusion Criteria:

  • Diagnosis of superficial bladder cancer

  • Scheduled for BCG intravesical therapy

  • Willing and able to give blood sample

  • Willing and able to fill out a pill diary to ensure compliance

Exclusion Criteria:

  • Pregnant patients

  • Diagnosis of invasive bladder cancer

  • HIV positive or immunocompromised

  • Presence of concurrent second cancer (active, not history)

Principal Investigator: Omer Kucuk, MD (Department of Hematology and Medical Oncology)

Co-Investigators & Collaborators: Kenneth Ogan, MD, Viraj Master, MD, PhD, John Pattaras, MD

Surgical Resection (PK Button)

PK Button Vaporization Electrode for Treatment of Bladder Tumors


  • Cystoscopically detected bladder tumors requiring TURBT

  • Endoscopically resectable by surgeon's judgment with only one trip to the operating room

Exclusion Criteria:

  • Lymphoma, or patients with any metastatic renal sites

Principal Investigator: Kenneth Ogan, MD

Co-Investigators & Collaborators: Viraj Master, MD, PhD, John Pattaras, MD


An Open-Label, Multicenter Phase 3 Study to Evaluate the Efficacy and Tolerability of Intravesical Vicinium™ in Subjects with Non Muscle-Invasive Carcinoma in Situ (CIS) and/or High-Grade Papillary Disease of the Bladder Previously Treated with Bacillus Calmette-Guérin (BCG)

Inclusion Criteria:

  • Histologically confirmed high-grade non muscle-invasive bladder cancer-CIS, Ta or any grade T1 papillary disease or CIS plus papillary disease, following adequate BCG treatment

  • The CIS, Ta, or T1 disease is documented as unresponsive (i.e. not tolerant) to adequate BCG therapy; unresponsive subjects may be either refractory or relapsing

  • Bladder biopsy confirming the diagnosis, observational mapping of the location of the tumors, and quantifying the affected area of bladder within eight weeks before study drug administration

Exclusion Criteria:

  • Evidence of urethral or upper tract transitional cell carcinoma (TCC) by biopsy or upper tract radiological imaging; subjects with hydronephrosis; current severe urinary tract infection or history of recurrent severe bacterial cystitis

  • Any intravesicular or other chemotherapy treatment within two weeks, or any investigational agent within four weeks prior to the initial dose of study drug 

  • History of other primary malignancy (other than squamous or basal cell skin cancers) that will require concomitant cancer therapy during the study period

Principal Investigator: Kenneth Ogan, MD

Co-Investigators & Collaborators: Viraj Master, MD, PhD, Mehrdad Alemozaffar, MD

rAd-IFN/Syn3 (Phase III)

A Phase III, Open Label Study to Evaluate the Safety and Efficacy of INSTILADRIN® (rAd-IFN/Syn3) Administered Intravesically to Patients with High Grade, BCG Unresponsive, Non-Muscle Invasive Bladder Cancer (NMIBC)

Inclusion Criteria:

  • "BCG unresponsive" patients with high grade NMIBC who are unlikely to benefit from and should not receive further intravesical BCG

  • Carcinoma in Situ (CIS) only; Ta/T1 high grade disease with concomitant CIS or Ta/T1 high grade disease without concomitant CIS

  • Absence of concomitant upper tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra

  • ECOG status two or less

  • "5+2" doses must be completed within one year (induction (5) + maintenance (2) or induction (5) + induction (2)). Exception: Those who have HGT1 at 1st evaluation after induction (5 or 6 doses) may qualify

  • All visible papillary tumors must be resected and those with persistent T1 disease on TURBT should undergo an additional re-TURBY within 14-60 days prior to study treatment start. Obvious areas of CIS should also be fulgurated

Exclusion Criteria:

  • Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease

  • Clinically significant and unexplained elevated liver or renal function tests, patients who cannot hold instillation for one hour, and patients who cannot tolerate intravesical dosing or intravesical surgical manipulation

  • Current systemic therapy for bladder cancer; prior treatment with adenovirus-based drugs

  • Existing urinary tract infection or bacterial cystitis

  • Suspected hypersensitivity to IFN alfa2b; current or prior pelvic external beam radiotherapy within five years of entry

  • History of malignancy of other organ system within past five years, except treated basal cell carcinoma or squamous cell carcinoma of the skin and ≤ pT2 upper tract urothelial carcinoma at least 24 months after nephroureterectomy. Also patients with genitourinary cancers other than urothelial cancer or prostate cancer that are under active surveillance

Principal Investigator: Mehrdad Alemozaffar, MD

Co-Investigators & Collaborators: Kenneth Ogan, MD, Viraj Master, MD, PhD

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