WT1 peptide cancer vaccine for solid tumors Phase I/II Clinical Trials Registration Form Hospital Department Attending doctor Country Address Phone number FAX E mail address Patient Information Name of Patient Date of Birth (year/ month/ date) / /, sex Hospital ID Disease Name Medical History Please attach another sheet if necessary. 1
Current Symptoms Please attach copies of Blood test results and Imaging test findings. Please attach another sheet if necessary. Past Histroty (Diseases in the past) Information about drug allergy. 2
Entry criteria Please check items below and confirm that all of them are fulfilled. 1 Is the tumor pathologically proved to be malignant solid one YES, NO Disease Please attach a copy of pathological image. 2 Is the patient informed of the disease shown in 1) Entry to the clinical trial is based on the will of a patient. However, not the patient but his/her family can make a decision to join the clinical trial when the patient suffers from primary brain tumor and consciousness disorder or dementia pretends him/her from making decision what medical treatment he/she will choose. 3 Are standard treatments ineffective? Or is the patient willing to prefer to be treated with WT1 peptide vaccine on his/her own free will? (When standard treatments are expected to be effective, please give priority to them). YES(standard therapy is ineffective), NO (effective) 4 Are there tumor lesions measurable by imaging tests such as CT and MRI or tumor marker? If YES, please describe methods of the tests 5 Are any treatments currently applied to the disease? If YES, please answer followings. What treatment is it? When was the last date of the treatment? year/ month/ date / / Is it possible to discontinue the treatment for more than four weeks before vaccination To evaluate the efficacy of WT1 peptide vaccination, all of current chemotherapy and rariation therapy must be discontinued for four weeks or more and hormonal therapy and BRM (Biological Response Modifier) for three weeks or more before the start of WT1 peptide vaccination. However, please continue present treatment till the schedule of vaccination is fixed. During the trial, other therapies than WT1 peptide vaccination are not combined. 6 Please answer following questions if the patient is not a case of primary brain tumor. Are any lesions in central nervous system not detected by CT or MRI or fully controlled?, not tested yet Imaging test test date year/ month/ date / / 3
7 Is the patient 16 years old or older and younger than 80 (16<= =<79) years old 8 Is the patient classified as ECOG Performance Status (PS) 0-1 PS ( ) Since the patient suffers from primary brain tumor, he/she is classified as PS2. (This case is allowed to entry the clinical trial.). Appendix Table ECOG performance status scale PS0 Fully active, able to carry on all pre-disease performance without restriction PS1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work PS2 Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours PS3 Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours PS4 Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair 9 Does parameters of major organs meet conditions below? peripheral blood test test date year/ month/ date / / blood neutrophil 1,000/µl /µl platelet 7.5 10 4 //µl /µl hemoglobin 8g/dL g/dl Was the patient administrated hematopoietic factor or transfused red blood cells/platelets within 14days from the above test date? YES NO date year/ month/ date / / biochemical examination of blood test day year/ month/ date / / AST GOT three-times the upper limit of your institution U/l ALT GPT three-times the upper limit of your institution U/l Bilirubin 1.5-times the upper limit of your institution mg/dl albumin 2.5g/dL mg/dl creatinine 2.0 mg/dl mg/dl 4
electrocardiogram normal lung function arterial oxygen saturation(spo2) 94% ( ) % 10 Is the patient free from pleural effusion, ascites, pericardial effusion or are they fully controlled (without any drainage treatment etc.)? 11 Is the patient expected to live more than three months even if WT1 vaccine treatment is ineffective? 12 Does the patient require regular intake of pain killer? times per day (NSAID ) (Opiate therapy ) Elimination criteria Please check items below and confirm that all of them are not fulfilled. 1) Does the patient have uncontrolled infectious disease (including tuberculosis)? 2) Does the patient develop severe complications (malignant high pressure, congestive heart failure, coronary failure, myocardial infarction (occurred within three months), advanced hepatic cirrhosis, uncontrolled diabetes, lung fibrosis, interstitial pneumonitis etc.? 3) Is the patient unsuitable for joining this clinical trial because of coexisting illness or concern on the safety due to medical phenomenon? Please refer to NCI-CTC ver. 3.0 Japanese version of JCOG http://www.jcog.jp/ and use grade 3 and above as a guide. 4) Is the patient unable to eat because of intestinal lesions etc. and needs intravenous blood transfusion, tubal feeding or TPN lasting 24hours or more? When a patient with primary brain tumor is unable to eat because of his/her disease, it is allowed to enter the clinical trial. 5) Does the patient have a lesion or lesions of hepatic metastasis occupying more than 1/3 volume of his/her liver? 6) Does the patient have an active double cancer? 7) Does the patient have myelodysplastic syndrome MDS or myeloproliferative disease (MPD) such as chronic myelocytic leukemia? 8) Did the patient undertake an allogeneic hematopoietic transplatation 5
9) Is the patient pregnant or a nursing mother? 10) Does the patient suffer from serious mental disorder? 6
Lastly please confirm following point. 1) The patient has HLA-A 2402. not tested yet The patient has HLA-A 0201. not tested yet In case HLA test is not performed yet, would you please collect blood*? *: We would like to ask you to collect about 1ml, apply it to the chromatography paper(we will send it to you) and send the paper to the testing institution. 2) Will it be possible to prepare six thin sliced tissue samples from paraffin bloc on glass slides for immunostaining (for example, MAS coated etc.) and send us? *This is to confirm the expression of WT1 protein in tumor cells. 3) We may have to give up vaccination if the patient does not fulfill the criteria on the day of vaccination even if the patient is in good condition and fulfill the entry criteria for the trial at this time. Would you understand this as an attending doctor? Also, will you please explain this to the patients and their families? Please fill out the patient name for confirmation. Thank you very much for your cooperation. Please fill out and post this sheet to the address below. Please do not FAX this form. Thank you for considering privacy protection in relation to personal data. Osaka University Graduate School of Medicine J3 Cacner Immunotherapy Clinical Trial Office for WT1 peptide vaccination 2-2, Yamada-Oka, Suita City, Osaka 565-0871, Japan 7