Bladder

ID:AAAC1114

Institutional
Principal Investigator: Dr. James Mckiernan

Adult: A Combined Phase I amp; II Trial of Intravesicular Abraxane, a nanoparticle albumin-bound paclitaxel, for Treatment-refractory Transitional Cell Carcinoma of the Urinary Bladder

This is a combined phase I and phase II study to determine the safety, toxicity, and efficacy of intravesically-administered Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), a biologically interactive albumin-bound paclitaxel in patients with transitional cell carcinoma (TCC) of the urinary bladder that has recurred after standard intravesical BCG therapy. This nonrandomized phase I trial will be designed to test if this novel treatment regimen has an appropriate safety and toxicity profile to be further investigated to afford patients a greater likelihood of complete response than the 20% response noted with currently available second line intravesical chemotherapy agents. TCC refractory patients will be enrolled in the Phase I portion of the study and these patients will receive weekly intravesical instillations of Abraxane once weekly for six weeks. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Bladder

ID:AAAC7449

Cooperative Group
Principal Investigator: Dr. Mitchell Benson

Adult: S0337,quot;A Phase III Blinded Study of Immediate Post-TURBT Instillation of Gemcitabine Versus Saline in Patients with Newly Diagnosed or Occasionally Recurring Grade I/II Superficial Bladder Cancer.quot;

This is a Phase III blinded study of immediate post-transurethral resection of the bladder (TURBT) instillation of Gemcitabine versus Saline in patients with newly diagnosed or occasionally recurring grade I/II Superficial Bladder Cancer. The primary objective of this study is to determine the efficacy of a single post-TURB intravesical instillation of gemcitabine versus saline in preventing recurrence of completely resected Grade 1 or 2, Ta or T1 transitional cell cancer (TCC) of the bladder at two years. Patients will be randomized to one of two treatment groups. Arm 1 pts. will receive gemcitabine 2,000 mg in 100 ml of 0.9% NaCl. Solution is to be held in the bladder for one hour. Arm 2 pts. will receive 100 ml of sterile 0.9% NaCl Solution. After randomization, patient will have a complete resection of all visible index bladder tumors (TURBT). Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Other Urinary, Bladder

ID:AAAI1368

Industry
Principal Investigator: Dr. Edward Gelmann

Adult: A RANDOMIZED PHASE 2 OPEN-LABEL STUDY EVALUATING DN24-02 AS ADJUVANT THERAPY IN SUBJECTS WITH HIGH RISK HER2+ UROTHELIAL CARCINOMA

This is a randomized, phase 2, open-label, research study evaluating an investigational treatment DN24-02 for subjects with urothelial cancer (cancer of the bladder, renal pelvis, urethra or ureter), who have had surgery to remove the cancer, and have a high risk of the cancer returning. The research investigators are studying an immune system treatment for urothelial cancer called DN24 02. DN24-02 uses cells, called antigen presenting cells, which is prepared from the subject?s own blood. An antigen is a substance, in this case a protein, which may be able to stimulate the body?s immune system. Antigen presenting cells are a type of white blood cell (cells that fight cancer and infections), and they are important to the immune system because they teach other white blood cells to recognize specific markers on other cells in your body. These blood cells are removed from the body, cultured with an antigen in the laboratory, and then put back into the body. Training the white blood cells to recognize markers may help the immune system find and attack cancer cells.The study compares subjects who receive DN24 02 to subjects who do not receive DN24 02. The main purpose of the study is to learn if DN24 02 helps subjects to live longer. Other purposes of the study are to learn about the safety of DN24 02, to learn if it delays the time until urothelial cancer returns, and to learn if the immune system responds to treatment with DN24 02. DN24-02 is an investigational treatment, which means that it has not been approved for commercial use by the United States Food and Drug Administration (FDA). Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Kidney, Bladder

ID:AAAI0285

Industry
Principal Investigator: Dr. Edward Gelmann

Adult: An Open-Label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of Docetaxel in Combination with Ramucirumab (IMC 1121B) Drug Product or IMC 18F1 or Without Investigational Therapy as Second-line Therapy in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Bladder, Urethra, Ureter, or Renal Pelvis Following Disease Progression on First-line Platinum-based Therapy.

This is an Open-Label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of Docetaxel in Combination with Ramucirumab (IMC 1121B) Drug Product or IMC 18F1 or Without Investigational Therapy as Second-line Therapy in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Bladder, Urethra, Ureter, or Renal Pelvis Following Disease Progression on First-line Platinum-based Therapy The main purpose of this study is to gather information about the efficacy of the use of two investigational drugs called ramucirumab drug product (ramucirumab DP) and IMC-18F1 when each agent is administered in combination with a chemotherapy called docetaxel. Being part of this study may or may not make you better. You will only be included in this study if you choose to participate voluntarily. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Kidney, Other Urinary, Prostate, Bladder

ID:AAAE9906

Cooperative Group
Principal Investigator: Dr. Edward Gelmann

Adult: A RANDOMIZED DOUBLE-BLINDED PHASE III STUDY COMPARING GEMCITABINE, CISPLATIN, AND BEVACIZUMAB (IND #7921, NSC #704865) TO GEMCITABINE, CISLPATIN, AND PLACEBO IN PATIENTS WITH ADVANCED TRANSITIONAL CELL CARCINOMA

This is a randomized, multi-center double-blinded phase III research study.The purpose of this study is to compare the effects of the combination of the chemotherapy drugs gemcitabine and cisplatin (chemotherapy) with the combination of gemcitabine, cisplatin, and the experimental drug bevacizumab on subjects with transitional cell cancer of the urinary tract to find out which is better. Bevacizumab is an antibody that may block a protein called VEGF and inhibit the growth of new blood vessels. Bevacizumab has been approved by the FDA for the treatment of metastatic colorectal, lung, and breast cancer, but for transitional cell carcinoma, it is not FDA-approved and should be considered experimental.Bevacizumab is the common name for the commercial drug Avastin. The bevacizumab used in this trial, however, is for use in research studies only. The combination of gemcitabine and cisplatin is one commonly used treatment that has been shown to make some patients with transitional cell carcinoma live longer. This research is being done to see if adding bevacizumab to gemcitabine and cisplatin will delay the growth of this cancer and allow subjects to live longer. The National Cancer Institute (NCI) will provide Bevacizumab free of charge to subjects who are participating in this study. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Bladder

ID:AAAI6557

Industry
Principal Investigator: Dr. Edward Gelmann

Adult: A Randomized, Double-blind Phase 2 Study Comparing Gemcitabine and Cisplatin in Combination with OGX-427 or Placebo in Patients with Advanced Transitional Cell Carcinoma.

The main purpose of this study is to find out if treatment with gemcitabine, cisplatin and study drug (OGX-427) at two different doses (600 mg and 1000 mg) can increase survival in subjects with TCC compared to gemcitabine, cisplatin and placebo. A placebo is a medication which contains no active ingredient. The study will also see if OGX-427 at two different dose levels is safe when given with gemcitabine and cisplatin.OGX 427 is a new drug that is experimental. Experimental means that it has not been approved by Health Canada, the Food and Drug Administration in the United States, or governmental regulatory agencies in other countries. OGX-427 reduces the level of a protein called Hsp27 which is overproduced in cancer cells such as bladder cancer. Hsp27 has been shown to help cancer cells protect themselves against the effects of cancer treatments. This means that the cancer drugs cannot work as well. OGX-427, the experimental or study drug, lowers the level of Hsp27 so that cancer drugs may work better.Approximately 180 people will take part in this study at about 40-50 international sites. All subjects will receive gemcitabine and cisplatin. About 60 subjects will receive OGX-427 at the 600 mg dose, 60 will receive OGX-427 at the 1000 mg dose, and 60 will receive placebo. It may take approximately 8 months for you to complete the study, depending on when your cancer progresses. After your disease has progressed, you will continue to be followed every three months for the rest of your life to look at the long-term effects of the study treatment and survival. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Bladder

ID:AAAK7800

Institutional
Principal Investigator: Dr. James Mckiernan

Adult: A Combined Phase 1 and Phase 2 Study of Albumin-bound Rapamycin Nanoparticles (nab-rapamycin, ABI-009) in the Treatment of BCG Refractory or Recurrent Nonmuscle Invasive Transitional Cell Bladder Cancer

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.