PARTICIPATION IN CALGB

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The UMCC has a longstanding relationship with CALGB. UMCC staff participate in administrative, scientific, committee and planning activities within the CALGB. The UMCC faculty design, conduct and chair studies and enter patients onto multiple CALGB protocols. Funding to continue and expand these activities will allow for the evolution of UMCC in-house phase I(2-4/year) studies into group phase II studies. UMCC also conducts pilot studies which have formed the conceptual basis for groupwide studies. UMCC sees many new patients with acute leukemia and funding will enhance UMCC participation and entry of these patients onto CALGB studies. Specialized laboratories at UMCC including cytogenetics and pharmacology will serve as a resource for collaborative efforts and innovative data base for future CALGB studies. UMCC and its collaborating institutions (VA Hospital, Baltimore) and physicians, (Drs. Lichtenfeld, Lichtenfeld and Sachs) propose to enter 80 to 90 patients per year onto CALGB studies. Participation in CALGB studies will allow UMCC as well as collaborating physicians greater treatment options for patients with these diseases. UMCC has completed its in-house ANLL study seeking to verify data from another group member. Current participation includes the entry of patients with leukemia on to a pilot study of high dose maintainence. Ancillary activities are evaluating the cellular pharmacology and sensitivity of Ara-C as well as the cytogenetics of leukemia cells utilizing both standard and methotrexate sychronized high resolution banding techniques. Pilot studies in acute leukemia include clinical and pharmacokinetic phase II studies of investigational agents such as AZQ high dose Ara-C in combination with additional agents and in vitro differentiators. A UMCC study of 5-Azacytidine and etoposide led to a CALGB protocol for CML in blast crisis. All breast cancer patients seen at UMCC are entered onto CALGB studies and nearly 10% of stage IV study accrual has come from UMCC. The current stage IV study, and several phase II studies have been designed and chaired at UMCC. UMCC studies in small cell lung cancer have established an active three drug combination which will serve as the basis for a pilot study currently being proposed for group activation and is likely to serve as a portion of the new extensive disease protocol for this disease. UMCC will also participate in selected CALGB phase II studies in both small cell and non-small cell lung cancer. Patients with uncommon tumors such as soft tissue sarcomas will be entered onto the intergroup studies through CALGB. This grant will allow UMCC to enter patients onto CALGB studies, participate on CALGB committees, develop meritorious pilot protocols, monitor and collect data to produce mutual benefit to the UMCC and CALGB.