Clinical Trials
Clinical trials are strictly controlled studies of new and emerging therapies. At MD Anderson, these trials incorporate state-of-the-art of patient care, while carefully evaluating how best to apply the most recent developments in cancer medicine.
We have clinical trials for every stage bladder cancer. Some are appropriate for newly diagnosed patients who have not undergone treatment. Others involve patients who have already received specific types of treatment, or whose treatment may have failed.
Bladder cancer trials are conducted in MD Anderson's Genitourinary Care Center.
Neoadjuvant chemotherapy
Low to intermediate risk
A Phase Ib Safety and Dose-Assessment Study of Neoadjuvant Ipilimumab Monotherapy in Patients with Urothelial Carcinoma Undergoing Surgical Resection: Bladder cancer is a tumor type that is responsive to treatments that activate the immune system. In the setting of superficial bladder cancer, BCG therapy is given into the bladder and can successfully activate immune responses against the tumor. However, for patients with recurrent disease after BCG treatment or patients whose disease are more advanced than superficial disease, surgical removal of the bladder may be recommended as the best curative therapy. In order to develop treatments that activate immune responses in these types of patients, we designed a clinical trial to treat patients with a new immunological agent, Ipilimumab, which has been shown to successfully activate immune responses in patients with other cancers, such as melanoma. Our clinical trial is aimed to determine if Ipilimumab can also successfully activate immune responses in bladder cancer patients.
Principal Investigator: Padmanee Sharma, M.D., Ph.D.
Protocol Number: 2006-0080
High risk (i.e., locally advanced)
A Phase II Clinical Trial of Neoadjuvant Chemotherapy with M-VAC Plus Avastin in Patients with Locally Advanced Urothelial Cancer: Our research found that cancers which over-express VEGF (Vascular Endothelial Growth Factor), have a higher rate of relapse despite pre-operative chemotherapy. Avastin is an anti-angiogenic drug which blocks blood vessel growth by binding to VEGF. This clinical trial involves aggressive chemotherapy given before surgical removal of the bladder in patients with a low chance of cure by means of surgery only. This trial is also available for patients with certain sub-types of bladder cancer that are known to be more aggressive.
Principal Investigator:Arlene O. Siefker-Radtke, M.D.
Protocol Number:2006-0620
Metastatic urothelial cancer
Phase I Two-Dimensional Dose-Finding Study of Bortezomib in Combination with Gemcitabine/Doxorubicin in Metastatic Surgically Unresectable Urothelial Cancer or Other Solid Tumors: Bladder cancer is a chemo-sensitive tumor with response rates on the order of 50-70% with front-line treatments. Unfortunately, when patients relapse, their tumors are less likely to respond as their cancer cells become more resistant to chemotherapy. Pre-clinical studies suggest that the proteosome inhibitor bortezomib can enhance the sensitivity of cancer cells to agents such as gemcitabine and doxorubicin and overcome this resistance. This trial is available for patients with metastatic urothelial cancer who have failed prior chemotherapy.
Principal Investigator:Arlene O. Siefker-Radtke, M.D.
Protocol Number:2006-0014
Phase II Trial of Weekly Docetaxel (Taxotere) versus Weekly Docetaxel in Combination with ZD1839 (Iressa® ) as Consolidation Therapy for Metastatic Urothelial Cancer Following Maximal Response to Multi-Agent Chemotherapy: Many patients who initially respond to chemotherapy, are at a high risk of relapse. Research from our Bladder SPORE suggest that agents such as docetaxel and iressa may delay cancer progression. This trial is available for patients with metastatic urothelial cancer who have responded to initial chemotherapy, and who wish to continue with milder low-dose chemotherapy as a means of trying to delay progression of their cancer.
Principal Investigator:Arlene O. Siefker-Radtke, M.D.
Protocol Number:2003-0767
Rare bladder tumors
Phase II Trial of 5-Fluorouracil, Leucovorin, Gemcitabine and Cisplatin for Adenocarcinomas of the Urothelial Tract and Urachal Remnant:This trial is only available at MD Anderson. It is for patients with a rare variant of bladder cancer.
Principal Investigator: Arlene Siefker-Radtke, M.D.
Protocol Number: ID03-0111
Non-muscle invasive (“superficial”) bladder cancer
A Randomized, Comparative, Controlled Phase III Multicenter Study of Hexvix Fluorescence Cystoscopy and White Light Cystoscopy in the Detection of Papillary Bladder Cancer and the Early Recurrence Rate in Patients with Bladder Cancer: This clinical study randomizes patients with multifocal or recurrent non-muscle invasive bladder cancer to conventional transurethral resection or transurethral resection using fluorescence. This study will assess the impact of fluorescence on bladder cancer detection and the rate of tumor recurrence.
Principal Investigator: H. Barton Grossman, M.D.
Protocol Number: 2004-0495
Markers of Response to Intravesical Bladder Cancer Therapy: This trial is designed for patients who are undergoing treatment with intravesical BCG (with or without interferon). Patients who are receiving such therapy will undergo various urinary and serum based tests. These tests are aimed to help us to develop a ‘risk profile’ to identify those patients who will fail therapy prior to actual manifestation of tumor. Such surrogate markers of response to intravesical immunotherapy would enable clinicians to offer tailored therapy to patients with bladder cancer, thus optimizing the timing of curative treatments for this disease. Of particular importance is our desire to make the study “user (i.e., patient and physician) friendly,” therefore, the study has been designed to allow the intravesical therapy to be administered in the office of the referring physician. Only specific assays will need be performed at MD Anderson Cancer Center.
Principal Investigator: Ashish M. Kamat, M.D.
Protocol Number: LAB05-0326
Modulation of Death Effector Expression by Short-Term Exposure to Low-Dose Interferon: Bladder cancer is responsive to treatments such BCG and interferon, which activate various facets of the immune system. It has also been shown that interferon therapy can modulate the expression of death receptors on bladder cancer cells and cause apoptosis (cell death). In order to understand the biology behind this phenomenon, and explore potential therapeutic strategies with death receptor directed therapy, we have designed a clinical trial to treat patients who are scheduled for transurethral resection of bladder tumors with systemic interferon (self-administered). After the tumor has been resected, various assays will then be performed to assess the in vivo effects of interferon exposure.
Principal Investigator: Ashish M. Kamat, M.D.
Protocol Number: ID03-0172
Phase III Open-Label, Multi-Center Study of the Efficacy and Safety of MCC in the Treatment of Patients with Non-Muscle Invasive (Superficial) Bladder Cancer at High Risk of Progression and Who Are Refractory to BCG: This trial is designed for patients who have non-muscle invasive (superficial) bladder cancer and have failed therapy with BCG, thus putting them at high risk of progression. The traditional recommendation for such patients is to proceed with radical cystectomy. Various bladder sparing therapeutic modalities have been tried, including salvage chemotherapy and interferon therapy, but the results are less than optimal. MCC (Mycobacterial Cell Wall-DNA Complex) has a dual mode of activity – BCG like immunostimulatory effects as well as chemotherapy like direct apoptosis inducing effects – and hence offers a potential for salvage therapy in these patients. The purpose of this trial is to evaluate its efficacy and study its safety profile in patients who have failed BCG therapy with high grade disease but do not wish to or are not able to undergo radical cystectomy.
Principal Investigator: Ashish M. Kamat, M.D.
Protocol Number: 2007-0091
Detection of Bladder Cancer by Microsatellite Analysis (MSA) of Urinary Sediment: The purpose of this study is to see if a new test performed on urine samples can detect bladder tumors. The bladder cancer test uses a technology known as microsatellite DNA analysis (MSA) and evaluates changes in certain genes that control bladder cancer growth.
Principal Investigator: Ashish M. Kamat, M.D.
Protocol Number: 2004-0051