EMD 273066 in Patients With Recurrent EpCAM Positive Ovarian, Prostate, Colorectal or Non-small Cell Lung Cancers When First Given Cyclophosphamide
NCT ID: NCT00132522
Last Updated: 2013-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
45 participants
INTERVENTIONAL
2005-05-31
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
EMD 273066
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.
Interventions
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EMD 273066
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.
Eligibility Criteria
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Inclusion Criteria
* No more than two lines of prior chemotherapy
* Positive EpCAM expression
* Karnofsky Performance Status \> 70%
* Adequate laboratory results
* Normal cardiac stress test
Exclusion Criteria
* Pregnant or lactating females
* Significant infection
* Prior receipt of EMD 273066
* Unable to interrupt anti-hypertensive medications 2 days prior to and through each cycle of study medication administration
* Uncontrolled hypertension
* Previous diagnosis of Addison's disease
* Previous diagnosis of an autoimmune disease
* Organ transplant
* Insulin-dependent diabetes
* History of acute pancreatitis
* Congestive heart failure
18 Years
ALL
No
Sponsors
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EMD Serono
INDUSTRY
Responsible Party
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Principal Investigators
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Joseph O'Connor, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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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
Countries
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References
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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.
Other Identifiers
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EMR 62206-015
Identifier Type: -
Identifier Source: org_study_id