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Breast CancerPhase 1NCT00709462

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

A Phase 1 study testing CDX1307 in people with Breast Cancer and Colorectal Cancer, run by Celldex Therapeutics at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CDX1307
How many people
48 participants
Where
3 sitesUnited States
Study dates
Mar 2004to Jun 2010
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have read, understood, and provided written informed consent and HIPAA authorization after the nature of the study has been fully explained.
  • Patients must be 18 years of age or older.
  • Patients with incurable breast, colorectal, pancreatic, ovarian or bladder cancer with measurable or evaluable disease.
  • Patients who have never received prior hCG-β therapy.
  • 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.
  • 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).
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  • 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.
  • Hormonal therapy including gonadotropin releasing hormone (GnRh) agonist, antiandrogens, selective estrogen receptor modulators (SERMs), aromatase inhibitors, and progestins.
  • Bisphosphonates.
  • Patients must have an ECOG Status of 0 or 1.
  • Patients must have a life expectancy ≥ 16 weeks.
  • Male patients who are sexually active must agree to practice an effective form of barrier contraception during the course of the study.
  • 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

Who cannot join

  • 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).
  • Previous administration of hCG-β vaccine or therapy.
  • Concurrent treatment with immunosuppressive or immunomodulatory agents.
  • Positive tests for HIV, HBV or HCV.
  • Patients with an active systemic infection requiring antibiotic treatment or a fever over 100°F within 72 hours prior to enrollment.
  • 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.
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  • 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.
  • 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.
  • History of anaphylactic reaction following exposure to humanized or human therapeutic monoclonal antibodies, or known hypersensitivity to GM-CSF, or yeast derived products.
  • 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.
  • 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.
  • 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).

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University

    Durham, North Carolina, 27710

  • Carolina BioOncology Institute Cancer

    Huntersville, North Carolina, 28078

Other trials in United States

About this 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)

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)

Read the 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.

Being tested
CDX1307
Keywords
Breast cancer, Colorectal cancer, Pancreatic cancer, Bladder cancer, Ovarian cancer, Metastatic cancer, Locally advanced cancer, Cancer Vaccine, Vaccine
Medical subject headings
Breast Neoplasms, Colorectal Neoplasms, Pancreatic Neoplasms, Urinary Bladder Neoplasms, Ovarian Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CDX1307Biological

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 2 years or until progression

Secondary outcomes (1)

  1. To evaluate dose-limiting toxicities, immune response, and clinical activity (tumor response and time to progression)

    Measured: up to 2 years or until progression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2008 (estimated)
  2. Study startMar 2004
  3. Primary completionMay 2010
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00709462
Sponsor's protocol ID
CDX-1307-01
Status last verified
Jul 2010
First submitted
1 Jul 2008
Last updated
26 Jul 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CDX1307 in people with Breast Cancer and Colorectal Cancer, run by Celldex Therapeutics at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00709462.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2010.

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