[c09aa8]: / clusters / clusters342final / clust_252.txt

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Patients must have a creatinine and AST =< grade 1
Serum creatinine =< grade 1
Patients must have a total serum bilirubin =< 1.5 x ULN (grade =< 1) and a serum creatinine =< grade 1
Creatinine =< grade 1
AST =< grade 1
Must have received bilateral radiation therapy, and subsequently developed grade 2 or 3 xerostomia, according to modified Radiation Therapy Oncology Group (RTOG) scale:* Grade 0 None* Grade 1 Slight dryness of mouth (good response on stimulation and no significant dietary alterations necessary)* Grade 2 Moderate dryness of mouth (poor response on stimulation and altered oral intake required such as frequent water, oral lubricants, or soft-moist foods)* Grade 3 Complete dryness of mouth (no response on stimulation and difficult oral alimentation; intravenous (IV) fluids, pureed diet or tube feedings may be required)* Grade 4 Fibrosis
Grade 2 or greater rash of any cause at time of study entry
Grade 2 or greater diarrhea of any cause at time of study entry
=< grade 2 hematuria (criteria applicable only for dose levels that include isotretinoin) and =< grade 2 proteinuria
=< grade 2 hypercalcemia (applicable only for dose levels that include cis retinoic acid [RA])
Skin toxicity =< grade 1
Patients must not have >= grade 2 diarrhea
No history of the following:* Class III or IV congestive heart failure (CHF)* Grade 3 or 4 thromboembolic event =< 6 months* Pericardial effusion =< 12 months (any grade)* Pericardial involvement with tumor* Grade 2 or higher pleural effusion =< 6 months
No history of the following:* Class III or IV congestive heart failure (CHF)* Pericardial effusion =< 12 months (grade 3 or 4)* Pericardial involvement with tumor* Grade 2 or higher pleural effusion =< 6 months
Patients must not have active pericardial effusion, ascites or pleural effusion of any grade based on chest x-ray and echocardiogram within 28 days prior to registration; exception: if the effusion is suspected to be related to the leukemia, the patient may have pericardial effusion =< grade 2 or pleural effusion =< grade 1
Patients with grade 1 NRSTS tumors of any size are not eligible
Patients with grade 3 ataxia or grade >1 extrapyramidal movement disorder are not eligible
Ongoing toxicities >= grade 2 from prior therapy
Participant has >= grade 2 diarrhea (participants with grade 1 diarrhea are eligible provided stool for ova/parasites and stool cryptosporidium studies are negative)
History of grade III hemorrhagic cystitis due to prior cyclophosphamide chemotherapy
Grade 3 or 4 immune related toxicity associated with prior ipilimumab therapy that has not resolved to grade 0 or 1
Grade 3-4 ascites or pleural effusion* Note: The following will NOT be exclusionary: A participant who is clinically stable following treatment for ascites or pleural effusion (including therapeutic thoracentesis or paracentesis)
Patients must have recovered to =< grade 2 following a significant adverse event or toxicity attributed to previous anti-cancer treatment except neurotoxicity which must be =< grade 1
Grade 2 or greater toxicity from prior therapy
Grade 2 or greater diarrhea
Grade 3-4 electrolyte abnormalities (CTCAE, v. 4):
Any prior grade >= 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE > grade 1
All ACT related toxicities resolved to grade 1 with the exception of alopecia, vitiligo and endocrine abnormalities requiring replacement therapy which may be grade 2
CNS toxicity =< grade 2
Patients with a history of, or current grade 4 depression are not eligible
Patients with grade 1 non-rhabdomyosarcoma soft tissue sarcomas (NRSTS) tumors of any size are not eligible
Patients with ataxia >= CTCAE grade 2 are ineligible
Histologic diagnosis of glioblastoma (WHO grade IV) or pilocytic astrocytoma (WHO grade I)