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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Ovarian Cancer, Colorectal Cancer, Carcinoma, Non-small-cell Lung, Prostate Cancer

Intervention / Treatment
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* Drug: EMD 273066


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: EMD 273066<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy |  | various timepoints | 
| safety |  | various timepoints | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EpCAM, monoclonal-antibody, targeted therapy, colorectal, prostate, non-small cell lung cancer, ovarian, solid tumor