A Safety and Efficacy Trial of Vaccine Boosting With Lethally Irradiated Allogeneic Pancreatic Tumor Cells Transfected With the GM-CSF Gene for the Treatment of Pancreatic Adenocarcinoma
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
A Safety and Efficacy Trial of Vaccine Boosting With Lethally Irradiated Allogeneic Pancreatic Tumor Cells Transfected With the GM-CSF Gene for the Treatment of Pancreatic Adenocarcinoma
OBJECTIVES:
Primary
- Determine the safety of primary and boost vaccinations with lethally irradiated
allogeneic pancreatic tumor cells transfected with sargramostim (GM-CSF) gene vaccine
in patients with surgically resected adenocarcinoma of the head, neck, or uncinate of
the pancreas.
Secondary
- Correlate specific in vivo parameters of immune response (e.g., mesothelin, prostate
stem cell antigen, and mutated k-ras-specific T-cell responses) with clinical response
in patients treated with this regimen.
- Determine the efficacy, in terms of overall and recurrence-free survival, of this
regimen in these patients.
- Correlate serum GM-CSF levels with longevity of an allogeneic vaccine after semi-annual
boosting in these patients.
- Determine the psychosocial (e.g., demographics, quality of life, hope, trust, social
support, decision control, and advanced directives) and symptom (e.g., pain, anorexia,
fatigue, and mood state) profiles in these patients and explore changes over time.
OUTLINE: This is a open-label study. Patients are stratified according to prior vaccination
with allogeneic sargramostim (GM-CSF)-secreting pancreatic tumor cell vaccine (yes [stratum
I] vs no [stratum II]).
- Stratum I: Patients receive booster vaccination comprising allogeneic GM-CSF plasmid
DNA pancreatic tumor cell vaccine subcutaneously (SC). Treatment repeats every 6 months
in the absence of disease progression or unacceptable toxicity.
- Stratum II: Patients receive priming vaccinations SC once a month for 3 months and then
receive booster vaccinations as in stratum I.
Patients complete self-reported psychosocial (including quality of life, hope, and trust)
and symptom (including pain, fatigue, anorexia, and mood) questionnaires at day 0 and day
28.
After completion of study treatment, patients are followed at day 28 and then annually for
15 years.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Confirmed diagnosis of adenocarcinoma of the head, neck, tail, or uncinate of the
pancreas meeting the following criteria:
- Stage I-III disease
- Prior surgical resection required
- No radiographic evidence of disease recurrence
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Hemoglobin ≥ 9 g/dL
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 2.0 mg/dL
- Bilirubin ≤ 2.0 mg/dL (unless due to known Gilbert's syndrome)
- AST, ALT, and amylase ≤ 2 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other uncontrolled illness
- No active, ongoing infection
- No history of autoimmune disease (e.g., systemic lupus erythematosus, sarcoidosis,
rheumatoid arthritis, glomerulonephritis, or vasculitis)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 28 days since prior anticancer therapy (e.g., adjuvant chemoradiotherapy)
- At least 28 days since prior systemic steroid therapy
- At least 6 months since last vaccination with sargramostim (GM-CSF) plasmid DNA
pancreatic tumor cell vaccine (cell lines Panc 10.05 and Panc 6.03) while enrolled on
SKCCC-J9617 or SKCCC-J9988
- No concurrent systemic steroid therapy during and for ≥ 28 days after vaccination
- No concurrent radiation therapy
- No other concurrent immunotherapy, biologic therapy, or gene therapy
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety as measured by local and systemic toxicities
Outcome Description:
Patients continue to receive vaccines until disease progression
Outcome Time Frame:
Until progression
Safety Issue:
Yes
Principal Investigator
Daniel A. Laheru, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sidney Kimmel Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
JHOC-J0619, CDR0000508892
NCT ID:
NCT00389610
Start Date:
September 2006
Completion Date:
Related Keywords:
- Pancreatic Cancer
- stage I pancreatic cancer
- stage II pancreatic cancer
- stage III pancreatic cancer
- adenocarcinoma of the pancreas
- Adenocarcinoma
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
