Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ludwig Institute for Cancer Research
With
Mie University
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Histological confirmation of cancer.
2. HER2 expression in tumor cells scored as 1+ or more which should be confirmed by IHC using at least two antibodies (archived issue; see Appendix 1 and Reference 1 for methodology).
or NY-ESO-1 expression by reverse transcriptase and polymerase chain reaction (RT-PCR) analysis (Appendix 2), preferably, or immunohistochemistry
3. Patients must
1. are at high risk of recurrence, more than 25% of probability, after complete resection or even after post-operative adjuvant treatment, and effective adjuvant therapy is not available or refused; or
2. have metastatic disease, and treatment has failed, or in the situation where effective therapy is not available, or has been refused.
4. Complete recovery from surgery (at least 4 weeks).
5. Laboratory values within the following limits:
Hemoglobin 9.0 g/dL or more, or 10.0 g/dL or more if \<50 kg Neutrophil count \>1.5 x 109/L Lymphocyte count \>0.5 x 109/L Platelet count \>100 x 109/L Serum creatinine ≤ 1.8 mg/dL Serum bilirubin ≤ 2 mg/dL
6. Performance status \> 70 (Karnofsky Scale) and life expectancy \>3 months.
7. Age 18 years or more.
You may not be if
1. Clinically significant heart disease (NYHA Class III or IV).
2. Cardiac dysfunction; less than 50% of ejection fraction by echocardiogram.
