Vaccine Therapy in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery - Full Text View

Sponsored by:	Sidney Kimmel Comprehensive Cancer Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00389610

Purpose

RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of pancreatic cancer.

PURPOSE: This phase II trial is studying the side effects and how well vaccine therapy works in treating patients with pancreatic cancer that has been removed by surgery.

Condition	Intervention	Phase
Cancer-Related Problem/Condition Fatigue Pain Pancreatic Cancer	Drug: sargramostim plasmid DNA pancreatic tumor cell vaccine	Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Sargramostim Granulocyte-macrophage colony-stimulating factor Pancrelipase Ultrase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Safety as measured by local and systemic toxicities [ Designated as safety issue: Yes ]
Number, type, and degree of toxicities as measured by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
Proportion of patients who experience dose-limiting toxicity within the first 28 days [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Overall survival [ Designated as safety issue: No ]
Recurrence-free survival [ Designated as safety issue: No ]
Immune response, in terms of mesothelin, prostate stem cell antigen, and mutated k-ras-specific T-cell responses, as measured by biopsy, histological analysis, and in vitro assays at baseline and at 4 weeks post vaccination [ Designated as safety issue: No ]
Antitumor immunity, in terms of shared tumor-specific antigens and k-ras-specific antitumor immune responses, as measured at baseline and at 4 weeks post vaccination [ Designated as safety issue: No ]
Correlation of immune response with clinical response [ Designated as safety issue: No ]
Correlation of sargramostim (GM-CSF) serum levels with longevity of an allogeneic vaccine as measured by pharmacokinetic (PK) studies at baseline and at day 3 [ Designated as safety issue: No ]
Correlation of PK parameters with clinical outcomes [ Designated as safety issue: No ]
Psychosocial profiles (demographics, quality of life [QOL], hope, trust, social support, decision control, & adv. directives) of long-term cancer survivors by EORTC QLQ-C30 v3 at baseline & day 28 of the 1st vacc. and each semiannual vacc. [ Designated as safety issue: No ]
Psychosocial profiles of long-term cancer survivors as measured by City of Hope QOL at baseline and day 28 of the first vaccination and each semiannual vaccination [ Designated as safety issue: No ]
Psychosocial profiles of long-term cancer survivors as measured by Cancer Patient/Survivor (QOL-CS) Version, and Herth Hope Index at baseline and day 28 of the first vaccination and each semiannual vaccination [ Designated as safety issue: No ]
Psychosocial profiles of long-term cancer survivors as measured by Symptom Distress Scale at baseline and day 28 of the first vaccination and each semiannual vaccination [ Designated as safety issue: No ]
Psychosocial profiles of long-term cancer survivors as measured by Trust Scale at baseline and day 28 of the first vaccination and each semiannual vaccination [ Designated as safety issue: No ]
Psychosocial profiles of long-term cancer survivors as measured by Pancreatic Cancer Survivor Survey at baseline and day 28 of the first vaccination and each semiannual vaccination [ Designated as safety issue: No ]
Symptom profile (pain, anorexia, fatigue, mood state) by EORTC QLQ-C30 v3 at baseline and day 28 of the first vaccination and each semiannual vaccination [ Designated as safety issue: No ]
Symptom profile (pain, anorexia, fatigue, mood state) by City of Hope QOL at baseline and day 28 of the first vaccination and each semiannual vaccination [ Designated as safety issue: No ]
Symptom profile (pain, anorexia, fatigue, mood state) by Cancer Patient/Survivor (QOL-CS) Version at baseline and day 28 of the first vaccination and each semiannual vaccination [ Designated as safety issue: No ]
Symptom profile (pain, anorexia, fatigue, mood state) by Herth Hope Index at baseline and day 28 of the first vaccination and each semiannual vaccination [ Designated as safety issue: No ]
Symptom profile (pain, anorexia, fatigue, mood state) by Symptom Distress Scale at baseline and day 28 of the first vaccination and each semiannual vaccination [ Designated as safety issue: No ]
Symptom profile (pain, anorexia, fatigue, mood state) by Trust Scale at baseline and day 28 of the first vaccination and each semiannual vaccination [ Designated as safety issue: No ]
Symptom profile (pain, anorexia, fatigue, mood state) by Pancreatic Cancer Survivor Survey at baseline and day 28 of the first vaccination and each semiannual vaccination [ Designated as safety issue: No ]
Clinical activity [ Designated as safety issue: No ]
Identification of markers of clinical response [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	September 2006
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Stratum I: Experimental Patients receive booster vaccination comprising allogeneic GM-CSF plasmid DNA pancreatic tumor cell vaccine subcutaneously (SC). Treatment repeats every 6 months.	Drug: sargramostim plasmid DNA pancreatic tumor cell vaccine Given subcutaneously
Stratum II: Experimental Patients receive priming vaccinations SC once a month for 3 months and then receive booster vaccinations as in stratum I.	Drug: sargramostim plasmid DNA pancreatic tumor cell vaccine Given subcutaneously

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389610

Locations

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410

Sponsors and Collaborators

Sidney Kimmel Comprehensive Cancer Center

Investigators

Principal Investigator:

Daniel A. Laheru, MD

Sidney Kimmel Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000508892, JHOC-J0619, JHOC-SKCCC-J0619, JHOC-00002731, JHOC-GT0604170201, JHOC-0607-799
Study First Received:	October 18, 2006
Last Updated:	October 18, 2008
ClinicalTrials.gov Identifier:	NCT00389610
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

pain
fatigue
psychosocial effects/treatment
anorexia

stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
adenocarcinoma of the pancreas

Study placed in the following topic categories:

Fatigue
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pain
Pancrelipase
Signs and Symptoms

Digestive System Diseases
Anorexia
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009