Phase I Study of CDX-1307, hCG-B Vaccine, for Patients With Incurable, Locally Advanced or Metastatic Breast, Colorectal, Pancreatic, Bladder or Ovarian Cancer

Phase 1

Completed

• Conditions: Breast Cancer; Colorectal Cancer; Pancreatic Cancer; Bladder Cancer; Ovarian Cancer

• Registration Number: NCT00648102
• Lead Sponsor: Celldex Therapeutics

Brief Summary

This research study is for individuals who have advanced breast, colon, pancreatic, ovarian or bladder cancer. Celldex Therapeutics, Inc. is testing a form of immune therapy (vaccine) to see if it can be used to make the immune system attack the cancer. The study includes administration of additional treatments, in combination, thought to enhance the immune response effect. This study specifically administers the vaccine systemically to explore whether dendritic cell targeted vaccines can generate more robust effects via intravenous injection. (CDX 1307-02)

Detailed Description

Protocol CDX1307-02: CDX-1307 is an investigational drug that is being tested to see if it can stimulate the immune system (the cells and substances that protect the body from infection and foreign matter) of people with certain kinds of cancer. It is believed that the body's immune system can attack tumor cells and kill them. It is thought that immune cells recognize special proteins on the surface of tumors as a signal to fight the cancer. One of these proteins is called human chorionic gonadotropin-beta (hCG-β) and is found on several types of cancers including breast, colorectal, pancreatic, bladder and ovarian. The study drug, CDX-1307, is given as an intravenous infusion (administered in a vein in the arm or through a port-a-catheter). In addition, the study includes combination therapies which are thought to stimulate the immune response against tumor cells. In addition, the study includes combination therapies which are thought to stimulate the immune response against tumor cells.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2008-03-28
• Study First Submitted QC: 2008-03-31
• Study First Posted: 2008-04-01
• Primary Completion: 2009-05
• Study Completion: 2009-12
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-23
• Last Update Posted: 2010-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To establish safety and tolerability profile of CDX1307 alone and with adjuvant in patients with breast, colorectal, pancreatic, bladder and ovarian cancer	up to 2 years or until progression

Secondary Outcome Measures

Name	Time	Method
Investigate clinical activity	up to 2 years or until progression

Trial Locations

Locations (3)

Carolina BioOncology Institute; 🇺🇸 Huntersville, North Carolina, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Duke University; 🇺🇸 Durham, North Carolina, United States