A Study of CDX-1307, in Patients With Incurable Breast, Colorectal, Pancreatic, Ovarian or Bladder Cancer (CDX 1307-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00709462
Recruitment Status : Completed
First Posted : July 3, 2008
Last Update Posted : July 26, 2010
Information provided by:
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. (CDX 1307-01)

Condition or disease Intervention/treatment Phase
Breast Cancer Colorectal Cancer Pancreatic Cancer Bladder Cancer Ovarian Cancer Biological: CDX1307 Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : March 2004
Actual Primary Completion Date : May 2010
Actual Study Completion Date : June 2010

Primary Outcome Measures :
  1. To establish the safety and tolerability profile of CDX-1307 in patients with incurable breast, colorectal, pancreatic, ovarian or bladder cancer, alone and in combination with adjuvants. [ Time Frame: up to 2 years or until progression ]

Secondary Outcome Measures :
  1. To evaluate dose-limiting toxicities, immune response, and clinical activity (tumor response and time to progression) [ Time Frame: up to 2 years or until progression ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  1. Patients must have read, understood, and provided written informed consent and HIPAA authorization after the nature of the study has been fully explained.
  2. Patients must be 18 years of age or older.
  3. Patients with incurable breast, colorectal, pancreatic, ovarian or bladder cancer with measurable or evaluable disease.
  4. Patients who have never received prior hCG-β therapy.
  5. Patients for whom therapy with potential survival benefit is available, or disease-specific palliation is the goal of therapy, must have received these appropriate standard of care therapies and experienced recurrence or progression while on that care. If no such therapy is available, patients with progressive disease may be enrolled. Patients who have refused standard of care options known to provide potential survival benefit or disease specific palliation are not eligible for this study.
  6. At least 4 weeks must have elapsed between prior therapy and first dose of the vaccine. Prior radiation therapy must be completed at least 4 weeks prior to the first vaccine dose. No prior radiopharmaceuticals within 8 weeks prior to the first vaccine dose. The patient must have recovered from any clinically significant toxicity experienced during prior treatment(s).
  7. 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.

    1. Hormonal therapy including gonadotropin releasing hormone (GnRh) agonist, antiandrogens, selective estrogen receptor modulators (SERMs), aromatase inhibitors, and progestins.
    2. Bisphosphonates.
  8. Patients must have an ECOG Status of 0 or 1.
  9. Patients must have a life expectancy ≥ 16 weeks.
  10. Male patients who are sexually active must agree to practice an effective form of barrier contraception during the course of the study.
  11. Screening laboratory values must meet the following criteria:

    • Neutrophils ≥1.5 x109/L
    • Platelets >100 x109/L
    • Hemoglobin <10 g/dL
    • Creatinine <2 mg/dL
    • AST <2 X ULN
    • Bilirubin <2 X ULN unless due to Gilbert's syndrome upper limit of normal.

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:

  • AST <4 X ULN
  • Bilirubin <4 X ULN

Exclusion Criteria

  1. Since treatment with CDX-1307 theoretically may cause permanent sterility, women of childbearing potential will be excluded (women who participate in this study must be post-menopausal [absence of menses for at least 1 year] and/or surgically incapable of bearing children).
  2. Previous administration of hCG-β vaccine or therapy.
  3. Concurrent treatment with immunosuppressive or immunomodulatory agents.
  4. Positive tests for HIV, HBV or HCV.
  5. Patients with an active systemic infection requiring antibiotic treatment or a fever over 100°F within 72 hours prior to enrollment.
  6. Generalized dermatologic conditions (such as allergic reactions, infection, edema, or scarring) that will not allow easy access for study drug administration or evaluation of localized adverse events.
  7. Patients with active central nervous system metastases, unless previously treated and asymptomatic for 2 months and not progressive in size or number for 2 months.
  8. History of a second malignancy, except for adequately treated and cured basal or squamous cell skin cancer or any other cancer from which the patient has been disease-free for ≥ 5 years.
  9. History of anaphylactic reaction following exposure to humanized or human therapeutic monoclonal antibodies, or known hypersensitivity to GM-CSF, or yeast derived products.
  10. Patients with any of the following conditions: myocardial infarction within 1 year of screening, congestive heart failure (unless LVEF ≥ 50% as determined by MUGA within 30 days of screening), uncontrolled hypertension (≥ 160 mm Hg/systolic and ≥ 100 mm Hg/diastolic), symptomatic or life-threatening arrhythmia persistent on medication at screening, or clinically evident chronic lung disease unless lung capacity ≥ 55% or FEV1 ≥ 60% at screening.
  11. Any underlying medical condition that in the Principal Investigator's opinion will make the administration of study drug hazardous to the patient or would obscure the interpretation of adverse events.
  12. Medical condition requiring the use of systemic corticosteroids (must be discontinued at least 4 weeks prior to enrollment. The use of inhaled corticosteroids is acceptable).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00709462

United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Carolina BioOncology Institute Cancer
Huntersville, North Carolina, United States, 28078
Sponsors and Collaborators
Celldex Therapeutics

Responsible Party: Celldex Therapeutics Identifier: NCT00709462     History of Changes
Other Study ID Numbers: CDX-1307-01
First Posted: July 3, 2008    Key Record Dates
Last Update Posted: July 26, 2010
Last Verified: July 2010

Keywords provided by Celldex Therapeutics:
Breast cancer
Colorectal cancer
Pancreatic cancer
Bladder cancer
Ovarian cancer
Metastatic cancer
Locally advanced cancer
Cancer Vaccine

Additional relevant MeSH terms:
Colorectal Neoplasms
Pancreatic Neoplasms
Ovarian Neoplasms
Urinary Bladder Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Gonadal Disorders
Urologic Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Immunologic Factors
Physiological Effects of Drugs