- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00709462
A Study of CDX-1307, in Patients With Incurable Breast, Colorectal, Pancreatic, Ovarian or Bladder Cancer (CDX 1307-01)
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 Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Health System
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University
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Huntersville, North Carolina, United States, 28078
- Carolina BioOncology Institute Cancer
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- 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).
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
Exclusion Criteria
- 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.
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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up to 2 years or until progression
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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up to 2 years or until progression
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Urinary Bladder Diseases
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Endocrine Gland Neoplasms
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Pancreatic Diseases
- Colorectal Neoplasms
- Ovarian Neoplasms
- Urinary Bladder Neoplasms
- Pancreatic Neoplasms
Other Study ID Numbers
- CDX-1307-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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