Status:
COMPLETED
Vaccine Therapy Combined With Adjuvant Chemoradiotherapy in Treating Patients With Resected Stage I or Stage II Adenocarcinoma (Cancer) of the Pancreas
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Vaccines made from gene-modified pancreatic cancer cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil, work in different ...
Detailed Description
OBJECTIVES: Primary * Determine overall and disease-free survival of patients with resected stage I or II adenocarcinoma of the pancreas treated with adjuvant chemoradiotherapy in combination with G...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed invasive ductal adenocarcinoma of the head, neck, and uncinate process of the pancreas
- Mixed adenocarcinoma tumors allowed if the predominant invasive component of the tumor is adenocarcinoma
- Stage I or II (clinical stage T1-3, N0-1, M0) disease
- Has undergone pancreaticoduodenectomy at the Johns Hopkins Hospital within the past 8-10 weeks
- Completely resected (R0) or microscopic residual (R1) disease
- No diagnosis other than ductal adenocarcinoma, including any of the following:
- Adenosquamous
- Squamous cell
- Colloid
- Islet cell
- Non-invasive intraductal papillary mucinous neoplasms
- 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
- Non-epithelial tumors (sarcoma, gastrointestinal stromal tumor, or lymphoma)
- Adenocarcinoma of the ampulla
- Adenocarcinoma of the distal bile duct
- Adenocarcinoma of the duodenum
- No recurrent disease
- No metastatic disease, including peritoneal implants or liver and/or lung involvement
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-1
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count \>/= 1,500/mm\^3
- Platelet count \>/= 100,000/mm\^3
- Hemoglobin \>/= 10 g/dL
- Hepatic
- Bilirubin \</= 2 mg/dL
- AST/ALT \</= 2 times upper limit of normal (ULN)
- Alkaline phosphatase \</= 5 times ULN
- Renal
- Creatinine \</= 2 mg/dL
- Pulmonary
- No asthma or chronic obstructive pulmonary disease requiring systemic corticosteroids
- Immunologic
- HIV negative
- No active infection
- No prior or concurrent autoimmune disease requiring 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
- Sjogren's syndrome
- Sarcoidosis
- Negative results to viral delayed-type hypersensitivity serology testing if autologous tumor cells are available
- Other
- No postoperative complications (e.g., inability to take oral nutrition \>/= 1,500 calories/day, ongoing requirement for long-term biliary stenting, or persistence of wound infection)
- No other malignancy within the past 5 years except nonmelanoma skin cancer
- No uncontrolled medical conditions that would preclude study participation
- No other major active medical or psychosocial problem that could be exacerbated by study treatment
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 4 weeks after study participation
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- More than 1 month since prior biologic therapy
- No other concurrent biologic therapy, immunotherapy, or gene therapy for pancreatic cancer
- Chemotherapy
- More than 1 month since prior chemotherapy
- No other concurrent chemotherapy for pancreatic cancer
- Endocrine therapy
- More than 28 days since prior systemic steroids
- No concurrent systemic corticosteroids
- Radiotherapy
- More than 1 month since prior radiotherapy
- No other concurrent radiotherapy for pancreatic cancer
- Surgery
- See Disease Characteristics
- Recovered from prior surgery
- Other
- More than 1 month since prior participation in an investigational new drug trial
- No other concurrent investigational therapy for pancreatic cancer
Exclusion
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00084383
Start Date
January 1 2002
End Date
July 1 2006
Last Update
July 22 2013
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231