- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00377247
Active Immunization of Patients With Carcinoma of Oral Cavity or Oropharynx With Autologous Dendritic Cells Transfected With DNA From Autologous Tumor
Active Immunization of Patients With Carcinoma of Oral Cavity or Oropharynx With Autologous Dendritic Cells Transfected With DNA From Autologous Tumor (Phase I/II Study)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is an uncontrolled, non-randomized trial to evaluate safety, immunogenicity and feasibility of a new vaccine, consisting of autologous monocyte-derived dendritic cells (DC) transfected with autologous tumor-derived DNA. Briefly, the plan is to use a two-stage trial design and to initially enroll 17 patients with primary advanced carcinoma of the oral cavity or oropharynx over a period of 2 years. The patients will undergo surgery, and a portion of the primary tumor specimen not necessary for the pathologic diagnosis will be obtained to serve as a source of tumor DNA. Each DC-based vaccine will contain DNA-transfected DC. It will be administered intranodally under ultrasound guidance. Only those patients who have normal delayed type hypersensitivity (DTH) responses to recall antigens will be eligible to receive the vaccine. Immunologic response to the vaccine will be evaluated. If there is no evidence of toxicity, and >3 patients show immunologic response, the second stage of the study will be opened for accrual of 22 patients. All patients will be monitored by interferon- gamma (IFN-) secretion in enzyme-linked immunospot (ELISPOT) assays prior to and after vaccination for the frequency of T-cells responsive to autologous tumor and to the vaccine. The patients will also be evaluated before and after vaccination for the capability of their T cells to respond to activating signals delivered via the T cell receptor (TcR).
Primary Objective: To determine the safety and feasibility of immunization of patients with carcinoma of the oral cavity or oropharynx with autologous monocyte-derived dendritic cells (DC) transfected with DNA obtained from the patient's own cancer cells.
Secondary Objective: To evaluate the ability of the DNA-based DC vaccine to induce immune responses to the vaccine as well as to autologous tumor.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Cancer Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
-
Written informed consent conforming to the institutional guidelines obtained from the patient.
Documented evidence of oral carcinoma or carcinoma of the oropharynx. Patients will undergo surgery, surgery and radiation or chemoradiation therapy, and will become eligible for the first vaccine between 1and 4 months after termination of conventional therapy.
Adequate immune competence, as indicated by positive reaction to one or more of the DTH skin tests.
Age 18 or above. Karnofsky performance status > 70% and life expectancy > eight months.
Adequate hematologic function:
Absolute neutrophil count > 1,000/mm3 Absolute lymphocyte count > 1,000/mm3 Hemoglobin > 9 g/dl Platelets > 100,000/mm3 h) Liver function tests: Bilirubin (total) < 1.7 mg/dl Alkaline phosphatase < 78 u/L (2 x ULN) SGOT < 54 u/L (2 x ULN) Lactic dehydrogenase < 180 u/L (2 x ULN) i) Kidney profile: Serum electrolytes Sodium 135-145 mEq/L Potassium 3.5-5.0 mEq/L Bicarbonate 21-28 mEq/L Chloride 100-108 mmol/L 2) Serum creatinine <4.5 mg/dL (3 x ULN) 3) BUN 8-25 mg/dL j) At least four weeks since any prior radiation therapy, immunotherapy, or chemotherapy
Exclusion Criteria:
- One or more of the Inclusion Criteria are not met. A significant history or current evidence of cardiac disease including, but not limited to, congestive heart failure, coronary artery disease, angina pectoris, uncontrolled hypertension, serious arrhythmias; or myocardial infarction within the previous six months.
Evidence of active infection requiring antibiotic therapy. Positive HIV or Hepatitis B or C screen tests Active intracranial metastases. Previously resected intracranial disease and or previously irradiated intracranial metastases which have been stable for four weeks are eligible.
History of other concurrent malignancies except basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
Pregnant or lactating women. Patients requiring systemic corticosteroids (unless patient has had NO STEROIDS IN THE PAST 4 WEEKS).
Autoimmune disease including, but not limited to, rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, or ankylosing spondylitis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Dendritic Cells w/Tumor DNA
|
The patients will receive 1 x 107 DC/vaccine delivered intranodally or perinodally to lymph nodes (LN) distant from the head and neck area (e.g., to inguinal LN)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the safety and feasibility of immunization of patients with the carcinomas of the oral cavity or the oropharynx with autologous DCs nucleofected with tumor DNA obtained from the patient's own tumor.
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine whether the immunological responses to the vaccine and/or antitumor immune responses can be induced in patients who receive the vaccine
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jonas T Johnson, M.D., UMPC/UPCI
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
Other Study ID Numbers
- 04-178
- NIH R01-DE13818
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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