A Trial of Boost Vaccinations of Pancreatic Tumor Cell Vaccine

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01088789
First received: March 1, 2010
Last updated: March 23, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Biological: PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1 neo vaccine.
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Safety and Feasibility Trial of Boost Vaccinations of a Lethally Irradiated, Allogeneic Pancreatic Tumor Cell Vaccine Transfected With the GM-CSF Gene

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Disease free overall survival. [ Time Frame: total of 13 years with 6 months between vaccines. ] [ Designated as safety issue: No ]
    Safety as measured by local and systemic toxicity according to NCI CTCAE v 3.0


Estimated Enrollment: 72
Study Start Date: April 2010
Estimated Study Completion Date: April 2023
Estimated Primary Completion Date: April 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm A
Vaccine only
Biological: PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1 neo vaccine.

A pancreatic vaccine secreting a granulocyte-macrophage colony-stimulating factor(GM-CSF). The vaccine consists of equal numbers of pancreatic cancer cells (Panc 6.03)and (Panc. 10.05) into a single vaccine.

The vaccine is administered every 6 months.

Other Name: Cyclophosphamide
Arm B
Arm B receives vaccine as well as a single dose of intravenous cyclophosphamide.
Biological: PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1 neo vaccine.

A pancreatic vaccine secreting a granulocyte-macrophage colony-stimulating factor(GM-CSF). The vaccine consists of equal numbers of pancreatic cancer cells (Panc 6.03)and (Panc. 10.05) into a single vaccine.

The vaccine is administered every 6 months.

Other Name: Cyclophosphamide
Arm C
In addition to Vaccine Arm C receives a daily dose of metronomic cyclophosphamide orally.
Biological: PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1 neo vaccine.

A pancreatic vaccine secreting a granulocyte-macrophage colony-stimulating factor(GM-CSF). The vaccine consists of equal numbers of pancreatic cancer cells (Panc 6.03)and (Panc. 10.05) into a single vaccine.

The vaccine is administered every 6 months.

Other Name: Cyclophosphamide

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01088789

Contacts
Contact: Lei Zheng, M.D., Ph.D 410-955-8893 lzheng6@jhmi.edu
Contact: Carol A Judkins, RN 410-614-5241 judkica@jhmi.edu

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21205
Contact       jhcccro@jhmi.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Lei Zheng, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01088789     History of Changes
Other Study ID Numbers: J09100, NA_00031401
Study First Received: March 1, 2010
Last Updated: March 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Adenocarcinoma
Cyclophosphamide
Immunotherapy
Neo-Adjuvant
Pancreatic tumor vaccine
GM-CSF
Randomize

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on August 21, 2014