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:
NCT00305760
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed ductal adenocarcinoma of the pancreas
* Mixed adenocarcinoma tumors eligible provided the predominant invasive component of the tumor is adenocarcinoma
* The following histologic diagnoses are not eligible:
* Adenosquamous
* Squamous cell
* Colloid
* Islet cell
* Serous or mucinous cystadenoma or cystadenocarcinoma
* Carcinoid
* Small or large cell carcinoma
* Intraductal oncocytic papillary neoplasms
* Osteoclast-like giant cell tumors
* Acinar cell carcinoma
* Pancreatoblastoma
* Solid pseudopapillary tumors
* Undifferentiated small cell carcinoma
* Nonepithelial tumors (sarcoma, gastrointestinal stromal tumor, lymphoma)
* Adenocarcinomas of the ampulla, distal bile duct, or duodenum
* Metastatic or locally advanced disease that is refractory to standard therapy OR for which patient refused standard therapy
* Measurable disease defined as ≥ 1 lesion unidimensionally measured as ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
* No nonmeasurable disease only including, but not limited to, the following:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural or pericardial effusion
* Inflammatory breast disease
* Lymphangitis cutis/pulmonis
* Abdominal masses that are not confirmed and followed by imaging techniques
* Cystic lesions
* No known active or untreated brain metastases
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* WBC ≥ 3,500/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Hemoglobin ≥ 9 g/dL
* Platelet count ≥ 90,000/mm\^3
* Creatinine ≤ 2.0 mg/dL
* Bilirubin ≤ 2 mg/dL
* ALT and AST ≤ 5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 5 times ULN
* No active infection
* No uncontrolled medical condition that would potentially increase the risk of toxicities or complications of study therapy
* No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
* No active peptic ulcer disease
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 4 weeks after completion of study treatment
* No other malignancy within the past 5 years except for nonmelanomatous skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
* HIV negative
* No active autoimmune disease or prior autoimmune disease requiring medical treatment with systemic immunosuppressants including any of the following:
* Inflammatory bowel disease
* Systemic vasculitis
* Scleroderma
* Psoriasis
* Multiple sclerosis
* Hemolytic anemia or immune thrombocytopenia
* Rheumatoid arthritis
* Systemic lupus erythematosus
* Sjögren's syndrome
* Sarcoidosis
* Asthma or chronic obstructive pulmonary disease that does not require systemic corticosteroids or routine use of inhaled steroids allowed
* No known or suspected hypersensitivity to sargramostim (GM-CSF), cyclophosphamide, pentastarch, corn, or DMSO
* No prior severe infusion reaction (\> grade 3) to a monoclonal antibody
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 1 month since prior adjuvant chemotherapy
* More than 4 weeks since prior surgery except for minor procedures (e.g., dental work, skin biopsy) and biliary stent placement
* No prior surgical procedures affecting absorption
* More than 4 weeks since prior radiotherapy
* More than 1 month since prior participation in an investigational new drug study
* No unresolved chronic toxicity (except alopecia) from prior anticancer therapy
* More than 28 days since prior systemic steroids
* No concurrent systemic steroids or immunosuppressive drugs
* Topical, inhaled, and intra-articular steroids allowed
* No other concurrent anticancer vaccine therapy
* No other concurrent chemotherapy, immunotherapy, radiotherapy, gene therapy, biologic therapy, or investigational therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00305760
Study Brief:
Protocol Section:
NCT00305760