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Sponsored by: |
Celldex Therapeutics |
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Information provided by: | Celldex Therapeutics |
ClinicalTrials.gov Identifier: | NCT00709462 |
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. (CDX 1307-01)
Condition | Intervention | Phase |
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Breast Cancer Colorectal Cancer Pancreatic Cancer Bladder Cancer Ovarian Cancer |
Biological: CDX1307 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study |
Official Title: | A Phase I, Open-Label, Dose-Escalation, Multidose Study of CDX-1307, a Mannose Receptor-Targeted hCG-β Vaccine, in Patients With Incurable Breast, Colorectal, Pancreatic, Ovarian or Bladder Cancer (CDX-1307-01) |
Estimated Enrollment: | 37 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Protocol CDX1307-01: 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 will be given as an injection under the skin (an intradermal or intracutaneous injection). In addition, the study includes combination with TLR agonists, which are thought to stimulate the immune response against tumor cells.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients on the following medications may be enrolled into the study if the medications were initiated 4 weeks or longer prior to screening and if no dosing changes are anticipated during the study.
Screening laboratory values must meet the following criteria:
Laboratory abnormalities attributed to liver involvement with cancer but outside of the normal range will be allowed if they do not exceed the following limits:
Exclusion Criteria
United States, Michigan | |
Henry Ford Health System | Recruiting |
Detroit, Michigan, United States, 48202 | |
Contact: Nikki Adams, RN 313-916-8862 NAdams9@hfhs.org | |
Contact: Robert Chapman, MD 313-916-1827 Rchapma1@hfhs.org | |
Principal Investigator: Robert Chapman, MD | |
United States, North Carolina | |
Duke University | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Nancy Lee, RN 919-668-5591 nancy.lee@duke.edu | |
Contact: Michael Morse, MD | |
Principal Investigator: Michael Morse, MD | |
Carolina BioOncology Institute Cancer | Recruiting |
Huntersville, North Carolina, United States, 28078 | |
Contact: Lori Lipocky, RN, OCN 704-947-6599 ext 106 llipocky@carolinabiooncology.org | |
Contact: John Powderly, MD 704-947-6599 jpowderly@carolinabiooncology.org | |
Principal Investigator: John Powderly, MD |
Responsible Party: | Celldex Therapeutics ( Celldex Therapeutics ) |
Study ID Numbers: | CDX-1307-01 |
Study First Received: | July 1, 2008 |
Last Updated: | November 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00709462 |
Health Authority: | United States: Food and Drug Administration |
Breast cancer Colorectal cancer Pancreatic cancer Bladder cancer Ovarian cancer |
Metastatic cancer Locally advanced cancer Cancer Vaccine Vaccine |
Gonadal Disorders Gastrointestinal Diseases Pancreatic Neoplasms Colonic Diseases Urogenital Neoplasms Ovarian Diseases Urologic Neoplasms Rectal Diseases Genital Diseases, Female Urologic Diseases Neoplasm Metastasis Breast Diseases Bladder neoplasm Endocrine Gland Neoplasms Ovarian cancer |
Cystocele Ovarian Neoplasms Digestive System Neoplasms Skin Diseases Urinary Bladder Diseases Urinary Bladder Neoplasms Genital Neoplasms, Female Endocrine System Diseases Breast Neoplasms Intestinal Diseases Intestinal Neoplasms Digestive System Diseases Pancreatic Diseases Gastrointestinal Neoplasms Endocrinopathy |
Neoplasms Neoplasms by Site Adnexal Diseases |