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Bladder Cancer Trials

For enrollment information involving the following trials, please contact one of the research staff members listed on Meet the Team.

Genistein Therapy (GIBBS STUDY)

Surgical Resection (PK BUTTON)

Vicinium

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, Peter Nieh, MD


Surgical Resection (PK Button)

PK Button Vaporization Electrode for Treatment of Bladder Tumors

Eligibility:

  • 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, Peter Nieh, MD


Vicinium

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, Peter Nieh, 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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