Status:
COMPLETED
Vaccine Therapy, Cyclophosphamide, and Cetuximab in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to ...
Detailed Description
OBJECTIVES: Primary * Determine the safety of pancreatic tumor vaccine, cyclophosphamide, and cetuximab in patients with metastatic or locally advanced adenocarcinoma of the pancreas. Secondary * ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00305760
Start Date
December 1 2005
End Date
March 1 2009
Last Update
February 19 2020
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410