Status:
WITHDRAWN
Combination of gp96-Ig Vaccine, Theophylline and Oxygen for the Treatment of Patients With Advanced, Relapsed or Metastatic Non-Small Cell Lung Cancer
Lead Sponsor:
Eckhard Podack
Conditions:
Non-Small Cell Lung Cancer
Non-small-cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
NSCLC tumors are appropriate targets for active immunotherapy, because they are non-immunogenic, which indicates that NSCLC does not stimulate a spontaneous immune response. NSCLC tumor-secreted gp96...
Detailed Description
This is a proof of principle trial investigating a heat shock protein gp96 Ig-secreting, allogeneic tumor cell-vaccine (gp96-Ig vaccine) administered in combination with suppression of adenosinergic p...
Eligibility Criteria
Inclusion
- Histologically confirmed NSCLC (squamous, adeno-, large cell anaplastic, bronchoalveolar, and non-small cell carcinoma NOS): stage IIIB with malignant pleural effusion, stage IV, or recurrent disease.
- At least one site of measurable disease.
- Brain metastasis if present and treated must be stable by CT scan or MRI for at least 4 weeks after treatment.
- Patient must have received and failed at least one line of palliative therapy (chemotherapy or biological therapy)
- Age \>= 18 years.
- ECOG performance status 0-2.
- Life expectancy \>= 3 months.
- Laboratory parameters
- Hemoglobin levels \>= 10.0 (transfusions allowed if necessary).
- ANC \>= 1,500.
- Platelets \>= 100k.
- Creatinine clearance \>= 50 ml/min.
- Total and direct bilirubin: \< 3.0 x upper institution limit for normal.
- Liver function tests: AST, ALT, and AlkP \< 3.0 x upper institution limit for normal.
- Signed informed consent.
Exclusion
- Active or symptomatic cardiac disease such as congestive heart failure, angina pectoris or recent myocardial infarction. Patients with history of these conditions who are stable taking cardiac medications will also be excluded.
- Pregnant or lactating women (negative test for pregnancy is required of women of childbearing potential).
- Known HIV infection.
- Uncontrolled or untreated brain or spinal cord metastases.
- Active infection.
- Concomitant steroid or other immunosuppressive therapy.
- Other active malignancies present within the past three years, except for basal and/or squamous cell carcinoma(s) or in situ cervical cancer.
- Meningeal carcinomatosis.
- Chemotherapy, radiation therapy, or other anti-tumor therapy during the last three weeks.
- Immune deficiency syndromes, including the following: rheumatoid arthritis, systemic lupus erythematousus, Sjogren's disease, sarcoidosis, vasculitis, polymyositis, glomerulonephritis.
- Compromised lung function:
- FeV1 \< 30% of the predicted value, or
- DLCO \< 30% of the predicted value, or
- PCO2 \> 45 mmHg.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01799161
Start Date
December 1 2014
Last Update
November 17 2014
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