This study is looking at the safety and tolerability of the experimental biological drug EMD 273066 when given with low dose cyclophosphamide to patients with recurring EpCAM positive ovarian, prostate, colorectal or non-small cell lung cancers. EMD 273066 is an experimental biological drug that may increase the immune response to certain cancers. Patients will be enrolled in groups of 3, with each successive group receiving a higher dose if the prior group adequately tolerates the study medication.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
dose-escalating study and subjects enrolled in the study may receive a maximum of 6 cycles of the assigned regimen over 18 weeks. Each cycle will be 3 weeks (21 days) with cyclophosphamide on Day 1 and EMD 273066 on Days 2 to 4, followed by 17 days with no experimental pharmaceutical product. Each cycle, cyclophosphamide at 300 mg/m2 given per institutional guidelines 1 day (22-28 hours) prior to 3 consecutive days of EMD 273066 as a 4-hour IV infusion at 1 of 6 planned dose levels of 0.5, 1, 2, 3, 4, or 6 mg/m2.
City of Hope
Durate, California, United States
Dartmouth Medical School, Pharmacology & Toxicology Dept. of Medicine
Lebanon, New Hampshire, United States
Fox Chase Cancer Oncology Department of Medical Oncology
Philadelphia, Pennsylvania, United States
University of Wisconsin Division of Gynecologic Oncology
Madison, Wisconsin, United States
Centre pluridisciplinaire d'Oncologie
Lausanne, Rue Du Bugnon, Switzerland
efficacy
Time frame: various timepoints
safety
Time frame: various timepoints
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