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GENITOURINARY
Advanced Renal Cell Carcinoma
Phase-I/II trial of Atragen and interferon alfa-2B in patients with advanced renal cell carcinoma (May-99 through Jul-03). Atragen is a formulation of the vitamin-A derivative called all-trans retinoic acid (ATRA), which induces tumor cells to differentiate into mature cells that do not proliferate abnormally. Interferon is an anti-viral chemical produced by the body that has been used with success against cancer.
Principal Investigator: Dr. David Nanus
0498-209
Advanced Renal Cell Carcinoma
7070-A0001-206: A phase-II study of E7070, an agent that interferes with cell division, for patients with progressive inoperable or metastatic renal-cell carcinoma.
Sponsor: Eisai, Inc.
Principal Investigator: Dr. David Nanus
CU14299
Carcinoma of the Urethelium
Phase-I/II trial of a sequence of drug combinations starting with doxorubicin and gemcitabine and proceeding to ifofamide, paclitaxel, and cisplatin chemotherapy. For patients with metastatic or locally advanced transitional cell carcinoma of the urethelium.
Principal Investigator: Dr. David Nanus
0298-121
Advanced Urethelial Cancer
NCI 198: Phase-II evaluation of trastuzumab (Herceptin), paclitaxel (Taxol), carboplatin, and gemcitabine in treatment of advanced urothelial cancer. The trial is for patients who have locally recurrent or metastatic urothelial carcinoma incurable by surgery or radiotherapy and whose tumor cells overexpress the growth-related receptor protein her-2/neu.
Consortium study: Weill Cornell (open), NYU (distributed), Mt. Sinai (distributed), North Shore(distributed) and Montefiore (distributed).
Sponsor: National Cancer Institute
0402-258
Oral Gallium Maltolate
Randomized study of the safety and pharmokinetics of gallium malolate against several cancers. The drug is an orally administered formulation of gallium, a semimetallic element that has demonstrated preliminary evidence of effectiveness when given intravenously. This study will test the safety of the oral form in four different doses and monitor serum concentrations of the drug in patients with prostate cancer, bladder cancer, multiple myeloma, and lymphoma. From this information an optimal dose will be selected for assessment of efficacy. Randomly selected patients will receive doses ranging from 50 to 1000 milligrams daily for up to six 42-day cycles.
Sponsor: Titan Pharmaceuticals
Principal Investigator: Dr. Matthew Milowsky
1202-621
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