Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

Safety and Tolerability of GemRIS 225 mg in Subjects With Muscle-Invasive Bladder Cancer

Protocol: OSU-16090

Full Title

A Phase 1b, Multicenter, Open Label Study Evaluating Safety, Tolerability and Preliminary Efficacy of GemRIS 225 mg in Subjects with Muscle-Invasive Transitional Cell Carcinoma of the Bladder

Purpose

The purpose of this study is to determine if GemRIS, an investigational drug-delivery

system, is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC) between

diagnosis and radical cystectomy (RC).

Are you eligible?

Inclusion Criteria:

Histological proof of muscle-invasive transitional cell carcinoma of the bladder

(stage II-IIIb). Patients with evidence of metastatic nodal disease to the obuturator

or presacral lymph nodes only may be included (N1 M0). Subjects with any degree of

fixation of the pelvic sidewall are not eligible.

Patient must have residual visible tumor following TURBT measuring no less than 3-cm.

Adequate laboratory parameters.

Subjects must be willing to undergo a cystoscopy on study for investigational product

removal.

Eligible for and willing to undergo radical cystectomy per the attending urologist.

Subjects must be deemed ineligible for cisplatin-based combination chemotherapy by

the attending medical oncologist.

Subjects medically eligible for neoadjuvant cisplatin-based combination chemotherapy

who refuse this therapeutic option and understand the risks and benefits of doing so.

Prior radiation therapy is allowed provided that no radiation therapy was

administered to the urinary bladder.

Written informed consent and HIPAA authorization for release of personal health

information.

Age > 18 years at the time of consent.

Exclusion Criteria:

A history of prior malignancy, however the following are allowed:

1. non-muscle invasive transitional cell carcinoma

2. adequately treated basal cell or squamous cell skin cancer

3. in situ cervical cancer

4. Gleason < grade 7 prostate cancers

5. Other cancer for which the subject has been disease-free for at least 5 years

Prior systemic chemotherapy for transitional cell carcinoma of the bladder. Any other

prior systemic chemotherapy for a non-urothelial carcinoma must have been completed >

5 years prior to initiation of study.

Previous exposure to gemcitabine instillations.

Currently receiving other intravesical chemotherapy.

Concurrent clinically significant infections as determined by the treating

investigator.

Presence of any bladder or urethral anatomic feature that in the opinion of the

investigator may prevent the safe placement, indwelling use or removal of GemRIS.

Documented history of vesicoureteral reflux or the presence of an indwelling ureteral

stent or nephrostomy tube at the time of screening.

Pelvic radiotherapy administered within less than 6 months prior to enrollment.

Subjects who received radiotherapy ≥ 6 months prior to enrollment must demonstrate no

cystoscopic evidence or symptoms of radiation cystitis.

Bladder Post-Void Residual Volume (PVR) of > 250-mL.

Active, uncontrolled urogenital bacterial, viral or fungal infections, including

urinary tract infection. Subject must not have a UTI within one month prior to GemRIS

Insertion Visit, Study Day 0. Skin/nail fungal infections are not exclusionary.

Subjects with active shingles (varicella zoster infection) will be excluded from the

study.

History or presence of any significant cardiovascular, pulmonary, hepatic, renal,

gastrointestinal, gynecological, endocrine, immunological, dermatological,

neurological or psychiatric disease or disorder that, in the opinion of the

investigator, contraindicates participation.

History of diagnosis of neurogenic bladder.

Concomitant immunosuppressive medications, such as methotrexate or TNF inhibitors,

within 2 weeks of Study Day 0.

Difficulty providing blood samples.

Unwilling or unable to provide informed consent or comply with the requirements of

this protocol, including the presence of any condition (physical, mental or social)

that is likely to affect the subject's return for scheduled visits and follow-up.

Other unspecified reasons that, in the opinion of the investigator or TARIS, make the

subject unsuitable for enrollment.

Bladder Cancer Genitourinary Cancers