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

Brief Summary

Official Title: “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.

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: June 2008

Interventions Used in this Clinical Trial

  • 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.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Arm 1

Outcome Measures for this Clinical Trial

Primary Measures

  • efficacy
    • Time Frame: various timepoints
      Safety Issue?: No
  • safety
    • Time Frame: various timepoints
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • EMD Serono
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joseph O’Connor, MD, Principal Investigator, University of Wisconsin, Madison

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00132522