Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT00496860
Eligibility Criteria:
ENTRY CRITERIA:
DISEASE CHARACTERISTICS:
* Locally advanced or metastatic malignancies
* Histologically or cytologically confirmed
* Evaluable
* Surgically and medically incurable
* Not responding to standard therapy or no other standard therapy exists
* Human leukocyte antigen (HLA)-A2.1/p53 positive
PRIOR/CONCURRENT THERAPY:
* No prior Proleukin therapy within one year
* No concurrent radiotherapy, chemotherapy, or other immunotherapy
* More than 4 weeks since prior major radiotherapy
* More than 4 weeks since prior cytotoxic therapy
* More than 6 weeks since prior nitrosoureas therapy
* More than 8 weeks since prior monoclonal antibody therapy
PATIENT CHARACTERISTICS:
Life expectancy
* \> 3 months
Performance status
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Bone marrow reserve
* Absolute neutrophil count (AGC/ANC) ≥ 1,500/microliters (uL)
* Platelets ≥100,000/uL
* Hemoglobin ≥ 10g/dL
Renal function
* Serum creatinine ≤ 1.5 X Upper limit of normal (ULN)
Hepatic function
* Total bilirubin ≤ 1.5 X ULN
* Aspartate Aminotransferase (AST) ≤ 2.5 X ULN
* Alkaline phosphatase ≤ 2.5 X ULN
* Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 X ULN
* Activated partial thromboplastin time (aPTT) ≤ 1.5 X ULN
Cardiovascular
* May be safely tapered off anti-hypertensives if currently on anti-hypertensives
* New York Heart Association classification I or II
* No congestive heart failure \<6 months
* No unstable angina pectoris \<6 months
* No myocardial infarction \<6 months
* No history of ventricular arrhythmias
* Normal cardiac stress test required if any of the following is present:
* Over age 50
* History of abnormal EKG
* Symptoms of cardiac ischemia or arrhythmia
Pulmonary
* Normal pulmonary function test (FEV1 ≥ 75% of predicted value) if any of the following is present:
* Prolonged history of cigarette smoking
* Symptoms of respiratory dysfunction
Other
* No known autoimmune disease
* No known HIV positive
* No psychiatric illness/social situations that would limit study compliance
* No history or evidence of central nervous system (CNS) disease
* No active systemic infection requiring parental antibiotic therapy
* No systemic steroid therapy required
* No prior organ allograft
* Not receiving other investigational agents
* Not receiving chronic medication for asthma
* Not pregnant or nursing
* Fertile patients must use effective contraception
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00496860
Study Brief:
Protocol Section:
NCT00496860