A Trial of Boost Vaccinations of Pancreatic Tumor Cell Vaccine
Conditions
Pancreatic Cancer
Conditions: official terms
Pancreatic Neoplasms
Conditions: Keywords
Adenocarcinoma, Cyclophosphamide, Immunotherapy, Neo-Adjuvant, Pancreatic tumor vaccine, GM-CSF, Randomize
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1 neo vaccine.
Type: Biological
Overall Status
Recruiting
Summary
The purpose of this study is to evaluate the safety and feasibility of long term boost vaccination of a lethally irradiated, allogenic pancreatic tumor cell vaccine transfected with the granulocyte macrophage colony-stimulating factor (GM-CSF) gene alone or given in combination with either a single intravenous dose or daily metronomic oral doses of cyclophosphamide for the treatment of patients with surgically resected adenocarcinoma of the head, neck, tail or the uncinate process of the pancreas.
Detailed Description
Primary Objective:

1. To evaluate the safety and feasibility of long term boost vaccinations of a lethally irradiated, allogeneic pancreatic tumor cell vaccine transfected with the GM-CSF gene given alone or in combination with either a single intravenous dose or daily metronomic oral doses of cyclophosphamide for the treatment of patients with surgically resected adenocarcinoma of the head, neck, or uncinate process of the pancreas.

Secondary Objective:

1. To assess the effect of boost vaccinations and long-term treatment of immune modulating doses of cyclophosphamide on the number, repertoire and avidity of peripheral mesothelin-specific CD8+ T cells.

2. To estimate disease-free and overall survival of surgically resected pancreatic adenocarcinoma patients treated with vaccine boosts with or without low dose cyclophosphamide.

Eligible subjects will receive by intradermal administration the pancreatic tumor vaccine consisting of two irradiated, allogeneic pancreatic tumor cell lines transfected with the granulocyte macrophage-colony stimulating factor (GM-CSF) gene with or without low dose cyclophosphamide. Study participants will be recruited from our prior three arm neoadjuvant vaccination with or without low dose cyclophosphamide trial and vaccine naive patients. The vaccination boosts will be offered as a continuation of care.

Patients from the J0810 study will remain on the same arm as the J0810 study where they have received the parental vaccine. The first vaccine boost will be given no sooner than six months (+/- 1 month) after the last prime vaccination. The vaccine will be administered for all arms once every six months (+/- 1 month) after the previous vaccine until ten years have passed, the subject no longer meets the eligibility criteria, no longer wishes to participate in the study, or the vaccine supply is exhausted. Arm A participants will receive the pancreatic cancer vaccine alone. Arm B participants will be vaccinated and receive a single low-dose of cyclophosphamide (200 mg/m2) intravenously one day prior to vaccination. Participants in Arm C will receive cyclophosphamide 50 mg once a day starting from 28 days prior to day 1 of vaccination till 28 days post vaccination.

Vaccine naive patients will first receive three prime vaccines each one month apart and each in combination with a single low-dose of cyclophosphamide (200 mg/m2)intravenously one day prior to vaccination. Then they will receive the boost vaccines as the participant in Arm B from the J0810 study.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Has a history of surgically resected and pathologically proved AJCC stage I or stage II adenocarcinoma of the head, neck, or uncinate of the pancreas.

2. Has been a participant in Hopkins IRB protocol (J0810) application number 00-01-58-58 entitled, "A randomized three-arm neoadjuvant and adjuvant feasibility and toxicity study of a GM-CSF secreting allogeneic pancreatic cancer vaccine administered either alone or in combination with either a single intravenous dose or daily metronomic oral doses of cyclophosphamide for treatment of patients with surgically resected adenocarcinoma of the pancreas"( the J0810 cohort), or have never received any type of pancreatic cancer vaccine/immunotherapy, had the Whipple surgery within 18 months and completed the planned adjuvant chemotherapy and /or chemoradiation (the vaccine naive cohort).

3. Has provided informed consent.

4. Has received the last irradiated GM-CSF transfected allogeneic pancreatic cell lines Panc 10/05/Panc 6.03 at least six months prior (+/- 1 month).Not applicable to the vaccine-naive cohort patients.

5. Has received the last anti-cancer therapy at least 28 days ago.

6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

7. Has adequate hematologic function.(Hemoglobin ≥ 9 g/dL ANC ≥ 1500/mm3 Platelets ≥ 100,000 K/ mm3).

8. Has adequate renal function? (Serum creatinine ≤ 2 mg/dL).

9. Has adequate hepatic function. (Bilirubin ≤ 2.0 mg/dl, unless known Gilbert's Syndrome; AST, ALT and amylase ≤ 2x upper limit of normal, Alk Phos ≤ 5x upper limit of normal).

10. Agree to use adequate birth control, if of childbearing potential.

Exclusion Criteria:

1. Has radiographic evidence of pancreatic cancer recurrence.

2. Has any documented history of autoimmune diseases including systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis,or vasculitis.

3. Has any uncontrolled medical problems.

4. Has had systemic steroid therapy within 28 days before vaccine administration.

5. Has an anticipated need for systemic steroid therapy within 28 days after vaccine administration.

6. Has any evidence of active infections.

7. Is pregnant.

8. Has a history of another cancer (other than pancreatic cancer) in the past five years except for treated non-melanoma skin cancer, superficial bladder cancer, or carcinoma in-situ of the cervix.

9. Has a history of noncompliance during previous vaccination cycles with study treatment and/or monitoring which is concerning for continued noncompliance.
Location
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Status: Recruiting
Contact: - jhcccro@jhmi.edu
Start Date
April 2010
Completion Date
April 2023
Sponsors
Sidney Kimmel Comprehensive Cancer Center
Source
Sidney Kimmel Comprehensive Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page