Active Immunization of Patients With Carcinoma of Oral Cavity or Oropharynx With Autologous Dendritic Cells Transfected With DNA From Autologous Tumor
Stopped early · Phase 1
Conditions studied: Primary Advanced Carcinoma of the Oral Cavity or Oropharynx, Squamous Cell Carcinoma of the Head and Neck
In brief
The primary goal of this study is to determine if the vaccine can be safely given to subjects, and to see what side effects occur (both good and bad) when they are given this experimental tumor vaccine. During this study, investigators intend to watch for tumor response while examining the effects of this vaccine on the body's immune system after it is given.
Key facts
- Study ID
- NCT00377247
- Run by
- University of Pittsburgh
- People needed
- 5
- Starts
- 2009-04-01
- Expected to finish
- 2009-04-01
- Last updated by the study team
- 2016-07-11
Who can join
Age: 37 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Pittsburgh Cancer Institute — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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