This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. CA4P is a novel anti-cancer agent that displays potent and selective toxicity towards tumor vasculature. Aside from its activity as a single agent in rodent tumor models, CA4P has been shown to enhance or act synergistically with several chemotherapy agents and radiation. CA4P was evaluated in three Phase I trials. The objectives of this trial are to determine the objective response rate, to determine the clinical predictors of response, and to further characterize the safety profile of CA4P given to patients with anaplastic carcinoma of the thyroid. The study also attempts to determine whether CA4P alters the natural history of anaplastic thyroid cancer by virtue of doubling the median survival of patients with advanced disease from 4-6 months to 12 months. To meet the sample size of 29 subjects, the study will enroll up to 36 subjects at three sites. Patients will receive CA4P at a dose of 45 mg/m2 as a 10-minute intravenous infusion weekly for 3 weeks followed by one week of rest (1 Cycle = 4 weeks). Subjects will come to the GCRC on an outpatient basis for medication administration and EKGs (after Cycle 2, EKG monitoring may be reduced; after Cycle 6, EKG monitoring may be halted). Pharmacokinetic sampling will be done only during Cycle 1. Cycles may continue until disease progression or for two cycles beyond documentation of complete remission.
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