- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00648102
Phase I Study of CDX-1307, hCG-B Vaccine, for Patients With Incurable, Locally Advanced or Metastatic Breast, Colorectal, Pancreatic, Bladder or Ovarian Cancer (CDX1307-02)
A Phase I, Open-Label, Dose-Escalation, Multidose Study of CDX-1307, a Mannose Receptor-Targeted hCG-β Vaccine, in Patients With Incurable Locally Advanced or Metastatic Breast, Colorectal, Pancreatic, Bladder and Ovarian Cancer
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
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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 incurable, metastatic or unresectable locally advanced breast, colorectal, pancreatic, bladder or ovarian cancer with measurable or evaluable-only disease. Locally advanced breast cancer is defined as inflammatory breast cancer with biopsy-proven skin involvement, or chest wall recurrence. Locally advanced disease of other histologies is defined according to the standard definition for that disease. Evaluable-only disease includes bone only or unresectable skin/chest wall only metastases, but does not include malignant effusion(s) only. Cancer with elevated serum tumor marker(s) (e.g. CA27.29, carcinoembryonic antigen, etc.) only does not constitute evaluable disease.
- Patients must be 18 years of age or older.
- Both genders may be enrolled.
- At least 4 weeks must have elapsed between prior therapy and initiation of treatment with CDX-1307. Prior radiation therapy must be completed at least 4 weeks prior to enrollment. No prior radiopharmaceuticals within 8 weeks prior to enrollment. 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 ≥ 8 weeks 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 Performance Status of 0 or 1.
- Breast cancer patients must have received and progressed through at least one line of chemotherapy or endocrine therapy for metastatic or unresectable locally advanced breast cancer. Patients with HER2-positive breast cancer must have received and progressed through at least one line of chemotherapy plus trastuzumab, or endocrine therapy plus trastuzumab, for metastatic or unresectable locally advanced breast cancer. For incurable colorectal, pancreatic, bladder, or ovarian cancer, where therapy with potential survival benefit is available or where disease-specific palliation is the goal of therapy, patients 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. Chemotherapy or radiation must be discontinued at least 4 weeks prior to initiation of vaccination with CDX-1307.
- 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.
* 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
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 2 years or age >55] 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 systemic infection within 72 hours of registration that require antibiotics or produce a fever > 101oF.
- Patients with active central nervous system metastases, unless previously treated and asymptomatic and not progressive in size or number for 2 months (1 month in the case of stereotactic radiation).
- History of a second malignancy, except for adequately treated and cured basal or squamous cell skin cancer or cervical cancer in situ; 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. Note that the performance of MUGA scans and Pulmonary Function Tests are not required except if clinically indicated.
- 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 corticosteroids (must be discontinued at least 4 weeks prior to enrollment).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To establish safety and tolerability profile of CDX1307 alone and with adjuvant in patients with breast, colorectal, pancreatic, bladder and ovarian cancer
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 |
---|---|
Investigate clinical activity
Time Frame: up to 2 years or until progression
|
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 by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Carcinoma
- Neoplasms, Glandular and Epithelial
- 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
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- CDX1307-02
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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