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A Safety and Feasibility Trial of Boost Vaccinations of a Lethally Irradiated, Allogeneic Pancreatic Tumor Cell Vaccine Transfected With the GM-CSF Gene


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

A Safety and Feasibility Trial of Boost Vaccinations of a Lethally Irradiated, Allogeneic Pancreatic Tumor Cell Vaccine Transfected With the GM-CSF Gene


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease free overall survival.

Outcome Description:

Safety as measured by local and systemic toxicity according to NCI CTCAE v 3.0

Outcome Time Frame:

total of 13 years with 6 months between vaccines.

Safety Issue:

No

Principal Investigator

Lei Zheng, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University

Authority:

United States: Food and Drug Administration

Study ID:

J09100, NA_00031401

NCT ID:

NCT01088789

Start Date:

April 2010

Completion Date:

April 2023

Related Keywords:

  • Pancreatic Cancer
  • Adenocarcinoma
  • Cyclophosphamide
  • Immunotherapy
  • Neo-Adjuvant
  • Pancreatic tumor vaccine
  • GM-CSF
  • Randomize
  • Pancreatic Neoplasms

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410