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July 2004

Clean Air for Healthy Children Pilot Research Project to Assess Change

Principal Investigator: Dottie Schell, Program Director Clean Air for Healthy Children

Collaborators: Alice Yoder & Robin Search

Sponsor: PA Department of Health/PA Chapter of the American Academy of Pediatrics

Objective: Pilot research project to assess practice change and patient change as a result of clean air smoking cessation training.


Evaluation of the Efficiency of New FDA Approved Equipment for Implantation of Pacemakers and Defibrillators

Principal Investigator: Seth J. Worley, MD

Collaborators: Douglas C. Gohn, MD

Sponsor: None

Objective: The purpose of this study is to evaluate the efficiency of FDA approved devices designed to facilitate the placement of pacing and sensing leads on/in various areas of the heart. These devices may be used in the inter-atrial septum, coronary sinus and coronary sinus tributary vessels. The study will evaluate new curve and length geometry of existing devices and devices that are modified on a case by case basis.


A Double-blind, randomized, placebo-controlled, parallel group, multicenter, phase IIb/III study to assess the efficacy and safety of NXY-059 in acute ischemic stroke

Principal Investigator: Venkatachalam Mangeshkumar, MD

Collaborator: Nagbhushan Rao, MD

Sponsor: Astra/Zenecca

Objective: The study is evaluating the neuroprotective agent NXY-059, a nitrone chemically, which traps free radicals, in the treatment of acute ischemic stroke patients presenting within 6 hours of the onset of symptoms.


A Phase III Randomized, Open-Label Study of CG1940 and CG 8711 versus Docetaxel and Prednisone in Patients with Metastatic Hormone-Refractory Prostate Cancer who are Chemotherapy-Naïve

Principal Investigator: Paul R. Sieber, MD

Collaborators: None

Sponsor: Cell Genesys

Objective: The primary objective of this study is to compare the duration of survival between the two treatment arms. The secondary objectives through comparison of both arms of treatment are the proportion of patients who: experience a bone related event, experience progression of bone metastases, time to onset of bone pain.


ECOG E-4402: A randomized, Phase III trial comparing two different rituximab dosing regimens for patients with low-tumor-burden, indolent non-Hodgkin's lymphoma.

Principal Investigator: Robert J. Gottlieb, MD

Collaborators: G. Thomas O'Connor, MD; Ashok Beedassy, MD; Shyam S. Balepur, MD; Elizabeth Horenkamp, MD

Sponsor: The Eastern Cooperative Oncology Group.

Objectives: To compare time to rituximab failure between the rituximab scheduled (single dose given every 12 weeks until disease progression) and rituximab re-treatment arms (four weekly doses at the time of disease progression).

Secondary objective will compare the toxicities between the two arms, document the rationale for beginning cytotoxic therapy, defined as chemotherapy, radiation therapy, or radioimmunotherapy, and compare the times to first cytotoxic therapy between the two arms.