Status:
WITHDRAWN
Vaccination of Advanced-Stage Lung Cancer Patients
Lead Sponsor:
University of Arkansas
Conditions:
Lung Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The overarching purpose of this study is to evaluate the clinical efficacy of an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in combination with standard-of-care (SoC) treatme...
Eligibility Criteria
Inclusion
- Advanced-stage (i.e., metastatic) Lung Cancer of any histologic type
- (Computed Tomography) CT scans were completed within 4 weeks prior to registration
- Age 18 years and older
- ECOG Performance Status 0 to 2
- White blood cell (WBC) count ≥ 3,000/mm3 within 3 weeks prior to registration
- Platelet count ≥ 100,000/mm3 within 3 weeks prior to registration
- Serum glutamic-pyruvic transaminase (SGPT) or alanine aminotransferase test (ALT) ≤ 2 x institutional upper limit (IUL) of normal obtained within 3 weeks prior to registration
- Serum glutamic-oxaloacetic transaminase (SGOT) or aspartate aminotransferase test (AST) ≤ 2 x institutional upper limit (IUL) of normal obtained within 3 weeks prior to registration
- Serum creatinine ≤ 1.8 mg/dL obtained within 3 weeks prior to registration
- Radiation is allowed
Exclusion
- Active infection requiring treatment with antibiotics
- Any other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment regimen
- Existing diagnosis or evidence of organic brain syndrome that might preclude participation in the full protocol
- Existing diagnosis or history of significant impairment of basal cognitive function that might preclude participation in the full protocol
- Existing diagnosis or history of leptomeningeal disease, spinal cord compression or brain metastases unless: (a) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, AND (b) subject has no residual neurological dysfunction and has been off corticosteroids for at least 14 days prior to registration
- Other current malignancy(s): Subjects with prior history at any time of any in situ cancer, including lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ or basal or squamous skin cancer are eligible, provided they are disease-free at the time of registration. Subject has other malignancies have been continuously disease free for ≥ 5 years prior to the time of registration. Subjects with other malignancies are eligible if they have been continuously disease free for ≥ 5 years prior to the time of registration.
- Active autoimmune disorders or conditions of immunosuppression; Existing autoimmune disorders or conditions of immunosuppression that have been in remission for less than 6 months.
- Treatment with corticosteroids, including oral steroids (i.e. prednisone, dexamethasone), continuous use of topical steroid creams or ointments or any steroid-containing inhalers. Subjects who have been on systemic steroids will require a 6-week washout period. Subjects who discontinue the use of these classes of medication for at least 6 weeks prior to registration are eligible if, in the judgment of the treating physician, the subject is not likely to require these classes of drugs during the treatment period. Replacement doses of steroids for subjects with adrenal insufficiency are allowed.
Key Trial Info
Start Date :
October 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02264236
Start Date
October 1 2015
End Date
June 1 2021
Last Update
July 20 2025
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205