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EMD 273066 in Patients With Recurrent EpCAM Positive Ovarian, Prostate, Colorectal or Non-small Cell Lung Cancers When First Given Cyclophosphamide

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ClinicalTrials.gov Identifier: NCT00132522
Recruitment Status : Completed
First Posted : August 22, 2005
Last Update Posted : October 25, 2013
Sponsor:
Information provided by (Responsible Party):
EMD Serono

August 19, 2005
August 22, 2005
October 25, 2013
May 2005
June 2008   (Final data collection date for primary outcome measure)
  • efficacy [ Time Frame: various timepoints ]
  • safety [ Time Frame: various timepoints ]
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Complete list of historical versions of study NCT00132522 on ClinicalTrials.gov Archive Site
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EMD 273066 in Patients With Recurrent EpCAM Positive Ovarian, Prostate, Colorectal or Non-small Cell Lung Cancers When First Given Cyclophosphamide
A Study to Find the Highest Dose of Biological Study Drug (EMD 273066) That Can Be Given Safely to Patients With Recurrent EpCAM Positive Ovarian, Prostate, Colorectal or Non-Small Cell Lung Cancers When First Given a Low Dose of Cyclophosphamide
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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Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Ovarian Cancer
  • Colorectal Cancer
  • Carcinoma, Non-small-cell Lung
  • Prostate Cancer
Drug: 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.

Experimental: Arm 1
Intervention: Drug: EMD 273066
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
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April 2009
June 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Recurrent non-small cell lung, colorectal, ovarian or prostate cancer
  • No more than two lines of prior chemotherapy
  • Positive EpCAM expression
  • Karnofsky Performance Status > 70%
  • Adequate laboratory results
  • Normal cardiac stress test

Exclusion Criteria:

  • Evidence of brain metastases
  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland,   United States
 
 
NCT00132522
EMR 62206-015
No
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EMD Serono
EMD Serono
Not Provided
Principal Investigator: Joseph O'Connor, MD University of Wisconsin, Madison
EMD Serono
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP