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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMD 273066 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| efficacy | various timepoints | |
| safety | various timepoints |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph O'Connor, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Durate | California | 91010 | United States | ||
| Dartmouth Medical School, Pharmacology & Toxicology Dept. of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23320927 | Derived | Connor JP, Cristea MC, Lewis NL, Lewis LD, Komarnitsky PB, Mattiacci MR, Felder M, Stewart S, Harter J, Henslee-Downey J, Kramer D, Neugebauer R, Stupp R. A phase 1b study of humanized KS-interleukin-2 (huKS-IL2) immunocytokine with cyclophosphamide in patients with EpCAM-positive advanced solid tumors. BMC Cancer. 2013 Jan 15;13:20. doi: 10.1186/1471-2407-13-20. |
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|
| Lebanon |
| New Hampshire |
| 03756 |
| United States |
| Fox Chase Cancer Oncology Department of Medical Oncology | Philadelphia | Pennsylvania | 19111 | United States |
| University of Wisconsin Division of Gynecologic Oncology | Madison | Wisconsin | 53792 | United States |
| Centre pluridisciplinaire d'Oncologie | Lausanne | Rue Du Bugnon | 46 | Switzerland |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D015179 | Colorectal Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C494047 | tucotuzumab celmoleukin |
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