Clinical trial NCT00389610: Adjuvant GVAX Vaccine Therapy in Patients With Pancreatic Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: stage I pancreatic cancer
stage II pancreatic cancer
pancreatic neoplasm
adenocarcinoma of the pancreas
stage IIl pancreatic cancer
adjuvant therapy
cancer vaccine
GVAX
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: The Skip Viragh Foundation
name: National Cancer Institute (NCI)
First posted: 2006-10-19
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open label, phase II trial study of adjuvant GVAX pancreas vaccine in patients with pancreatic cancer.

Detailed description: Eligible participants will receive by intradermal administration the GVAX pancreas vaccine consisting of two irradiated allogeneic pancreatic tumor cell lines transfected with the granulocyte macrophage-colony stimulating factor (GM-CSF) gene.

There will be two cohorts of research participants:

1. Participants previously vaccinated with GVAX pancreas vaccine. These participants will receive booster vaccinations as a continuation of care. Vaccination repeats every 6 months in the absence of disease progression or unacceptable toxicity.
2. Participants who were not previously vaccinated with GVAX pancreas vaccine (vaccine naive). These participants received priming vaccinations once a month for 3 months followed by booster vaccinations every 6 months.

Eligibility criteria: 1. Inclusion Criteria:

   A. previously vaccinated subjects must receive Gvax vaccine previously

   B. naïve and previously vaccinated subjects must meet the following criteria:
   * have a history of surgically resected pathologic stage 1,2 or 3 adenocarcinoma of the head, neck, tail, or uncinate of the pancreas
   * received the last anti-cancer therapy at least 28 days ago.
   * provide informed consent.
   * have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
   * have adequate hematologic function (Hemoglobin ≥ 9 gm/dl, Absolute neutrophil count (ANC) ≥ 1500 #/cu mm, platelets ≥100,000 K/cu mm)
   * have adequate renal function (Serum creatinine ≤ 2 mg/dL).
   * have adequate hepatic function (Bilirubin ≤ 2.0 mg/dL, unless known Gilbert's Syndrome; Aspartate Aminotransferase (AST), Alanine transaminase (ALT) and amylase ≤ 2x upper limit of normal: Alk Phosphatase ≤ 5x upper limit of normal.)
   * agree to use adequate birth control, if of childbearing potential.
2. Exclusion criteria:

   * radiographical evidence of pancreatic cancer disease recurrence
   * documented history of autoimmune diseases including systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis
   * uncontrolled medical problems
   * systemic steroid therapy within 28 days before vaccine administration
   * anticipated need for systemic steroid therapy within 28 days after vaccine administration
   * evidence of active infections
   * pregnant

Primary outcomes:
measure: Number of Patients Experiencing a Grade 3 or Above Treatment- Related Toxicity
timeFrame: 14 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 16 years
measure: Disease-free Survival (DFS)
timeFrame: 16 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Daniel A. Laheru, MD
role: PRINCIPAL_INVESTIGATOR
References: