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

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono
• Treatments: Cyclophosphamide; Interleukin-2

Criteria

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