Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Vaccine Therapy in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Natural history/Epidemiology, Treatment Completed 18 and over Other JHOC-J0619 JHOC-SKCCC-J0619, JHOC-00002731, JHOC-GT0604170201, JHOC-0607-799, NCT00389610

Objectives

Primary

1. 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

1. 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.
2. Determine the efficacy, in terms of overall and recurrence-free survival, of this regimen in these patients.
3. Correlate serum GM-CSF levels with longevity of an allogeneic vaccine after semi-annual boosting in these patients.
4. 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.

Entry 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

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

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)

Expected Enrollment

A total of 100 patients will be accrued for this study.

Outcomes

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

Overall survival
Recurrence-free survival
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
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
Correlation of immune response with clinical response
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
Correlation of PK parameters with clinical outcomes
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.
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
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
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
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
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
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
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
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
Symptom profile (pain, anorexia, fatigue, mood state) by Herth Hope Index at baseline and day 28 of the first vaccination and each semiannual vaccination
Symptom profile (pain, anorexia, fatigue, mood state) by Symptom Distress Scale at baseline and day 28 of the first vaccination and each semiannual vaccination
Symptom profile (pain, anorexia, fatigue, mood state) by Trust Scale at baseline and day 28 of the first vaccination and each semiannual vaccination
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
Clinical activity
Identification of markers of clinical response

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.

Trial Contact Information

Trial Lead Organizations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Daniel Laheru, MD, Principal investigator		Ph: 410-955-8974

Registry Information
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
Trial Start Date		2006-09-08
Trial Completion Date		2008-02-14
Registered in ClinicalTrials.gov		NCT00389610
Date Submitted to PDQ		2006-09-08
Information Last Verified		2008-01-09
NCI Grant/Contract Number		CA06973

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