Clinical trial · Interventional
Vaccine Therapy Combined With Adjuvant Chemoradiotherapy in Treating Patients With Resected Stage I or Stage II Adenocarcinoma (Cancer) of the Pancreas
A Safety and Efficacy Trial of Lethally Irradiated Allogeneic Pancreatic Tumor Cells Transfected With the GM-CSF Gene in Combination With Adjuvant Chemoradiotherapy for the Treatment of Adenocarcinoma of the Pancreas
NCT00084383CI-TRIAL-00011445completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving vaccine therapy together with chemotherapy and radiation therapy after surgery may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well giving vaccine therapy together with adjuvant chemoradiotherapy works in treating patients with resected stage I or stage II adenocarcinoma (cancer) of the pancreas.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GVAX pancreatic cancer vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GVAX pancreatic cancer vaccine
- description
- 5E8 vaccine cells. The first vaccination is administered 6-8 weeks after surgery. Four to eight weeks following the completion of the last cycle of adjuvant radiation and chemotherapy (chemo-radiation therapy is standard of care and not part of the protocol) eligible patients will receive three additional vaccinations at one month intervals. Patients who continue to remain disease-free will receive a fifth "booster" vaccination, six months following the fourth vaccination
- interventionNames
- Biological: GVAX pancreatic cancer vaccine
Primary outcomes (2)
- measure
- Overall Survival
- timeFrame
- Participants were followed for the duration of the study, an average of 2 years
- description
- Overall survival in patients treated with adjuvant chemoradiotherapy in sequence with the irradiated allogeneic GM-CSF transfected pancreatic tumor cell lines. Overall survival is defined as time from surgery until death, regardless of cause.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLutz E, Yeo CJ, Lillemoe KD, Biedrzycki B, Kobrin B, Herman J, Sugar E, Piantadosi S, Cameron JL, Solt S, Onners B, Tartakovsky I, Choi M, Sharma R, Illei PB, Hruban RH, Abrams RA, Le D, Jaffee E, Laheru D. A lethally irradiated allogeneic granulocyte-macrophage colony stimulating factor-secreting tumor vaccine for pancreatic adenocarcinoma. A Phase II trial of safety, efficacy, and immune activation. Ann Surg. 2011 Feb;253(2):328-35. doi: 10.1097/SLA.0b013e3181fd271c. PMID 21217520