Phase 2
N=60
Vaccine Therapy Combined With Adjuvant Chemoradiotherapy in Treating Patients With Resected Stage I or Stage II Adenocarcinoma (Cancer) of the Pancreas
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00084383 ↗Enrolled (actual)
60
Serious AEs
3.3%
Results posted
Jul 2013
Primary outcome: Primary: Overall Survival — 24.8 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GVAX pancreatic cancer vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Dec 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
24.8 | — |
| PRIMARY Disease-free Survival |
17.3 | — |
| SECONDARY To Further Identify and Characterize Toxicities Associated With Intradermal Injections of the Vaccine That Were Initially Reported in the Phase 1 Trial. |
— | — |
| SECONDARY Estimate the Association of Specific in Vivo Parameters of Immune Response With Clinical Responses in Patients Treated With Combination Chemoradiotherapy Together With the Irradiated Allogeneic GM-CSF Transfected Pancreatic Tumor Cell Lines. |
— | — |
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 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.
Eligibility Criteria
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 /= 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
Data sourced from ClinicalTrials.gov (NCT00084383). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.