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A Trial of Boost Vaccinations of Pancreatic Tumor Cell Vaccine

Primary Purpose

Pancreatic Cancer

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1 neo vaccine.

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Adenocarcinoma, Cyclophosphamide, Immunotherapy, Neo-Adjuvant, Pancreatic tumor vaccine, GM-CSF, Randomize

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
Cohorts 1, 3, 4 and 5: Have been a participant in Hopkins IRB protocol J0810, J1568, J15237 or J1766.
Cohort 2: 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.
Cohorts 1, 3, 4 and 5: Received the last irradiated GM-CSF transfected allogeneic pancreatic cell lines Panc 10.05 and Panc 6.03 at least 6-12 months prior.
Has received the last anti-cancer therapy at least 28 days ago.
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Has provided informed consent.
Has adequate hematologic function.(Hemoglobin ≥ 9 g/dL ANC ≥ 1500/mm3 Platelets ≥ 100,000 K/ mm3).
Has adequate renal function (Serum creatinine ≤ 2 mg/dL).
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).
Agree to use adequate birth control, if of childbearing potential.

Exclusion Criteria:

Has radiographic evidence of pancreatic cancer recurrence.
Has any documented history of autoimmune diseases including systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis,or vasculitis.
Has any uncontrolled medical problems.
Has had systemic steroid therapy within 28 days before vaccine administration.
Has an anticipated need for systemic steroid therapy within 28 days after vaccine administration.
Has any evidence of active infections.
Is pregnant.
Has a history of another cancer (other than pancreatic cancer) or myeloproliferative disorders in the past five years except for treated non-melanoma skin cancer, superficial bladder cancer, or carcinoma in-situ of the cervix.
Has a history of noncompliance during previous vaccination cycles with study treatment and/or monitoring which is concerning for continued noncompliance.

Sites / Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Arm Description

Arm A: Vaccine only. Arm B receives vaccine as well as a single dose of intravenous cyclophosphamide. Arm C: In addition to Vaccine Cohort 3 receives a daily dose of metronomic cyclophosphamide orally. Only patients from the J0810 study are eligible. Closed to enrollment.

Cohort 2 receives vaccine as well as a single dose of intravenous cyclophosphamide. Vaccine-naïve cohort. Closed to enrollment.

Cohort 3 receives vaccine as well as a single dose of intravenous cyclophosphamide. Only participants from J1568 study are eligible.

Cohort 4 receives vaccine as well as a single dose of intravenous cyclophosphamide. Only participants from J15237 study are eligible.

Cohort 5 receives vaccine as well as a single dose of intravenous cyclophosphamide. Only participants from J1766 study are eligible.

Outcomes

Primary Outcome Measures

Disease free overall survival.

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01088789

First Posted

March 1, 2010

Last Updated

March 6, 2023

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

The Skip Viragh Foundation

1. Study Identification

Unique Protocol Identification Number

NCT01088789

Brief Title

A Trial of Boost Vaccinations of Pancreatic Tumor Cell Vaccine

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 20, 2010 (Actual)

Primary Completion Date

August 2023 (Anticipated)

Study Completion Date

August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

The Skip Viragh Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

Adenocarcinoma, Cyclophosphamide, Immunotherapy, Neo-Adjuvant, Pancreatic tumor vaccine, GM-CSF, Randomize

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

71 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Other

Arm Description

Arm Title

Cohort 2

Arm Type

Other

Arm Description

Cohort 2 receives vaccine as well as a single dose of intravenous cyclophosphamide. Vaccine-naïve cohort. Closed to enrollment.

Arm Title

Cohort 3

Arm Type

Other

Arm Description

Cohort 3 receives vaccine as well as a single dose of intravenous cyclophosphamide. Only participants from J1568 study are eligible.

Arm Title

Cohort 4

Arm Type

Other

Arm Description

Cohort 4 receives vaccine as well as a single dose of intravenous cyclophosphamide. Only participants from J15237 study are eligible.

Arm Title

Cohort 5

Arm Type

Other

Arm Description

Cohort 5 receives vaccine as well as a single dose of intravenous cyclophosphamide. Only participants from J1766 study are eligible.

Intervention Type

Biological

Intervention Name(s)

PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1 neo vaccine.

Other Intervention Name(s)

Cyclophosphamide

Intervention Description

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.

Primary Outcome Measure Information:

Title

Disease free overall survival.

Description

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

Time Frame

total of 13 years with 6 months between vaccines.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Cohorts 1, 3, 4 and 5: Have been a participant in Hopkins IRB protocol J0810, J1568, J15237 or J1766. Cohort 2: 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. Cohorts 1, 3, 4 and 5: Received the last irradiated GM-CSF transfected allogeneic pancreatic cell lines Panc 10.05 and Panc 6.03 at least 6-12 months prior. Has received the last anti-cancer therapy at least 28 days ago. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Has provided informed consent. Has adequate hematologic function.(Hemoglobin ≥ 9 g/dL ANC ≥ 1500/mm3 Platelets ≥ 100,000 K/ mm3). Has adequate renal function (Serum creatinine ≤ 2 mg/dL). 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). Agree to use adequate birth control, if of childbearing potential. Exclusion Criteria: Has radiographic evidence of pancreatic cancer recurrence. Has any documented history of autoimmune diseases including systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis,or vasculitis. Has any uncontrolled medical problems. Has had systemic steroid therapy within 28 days before vaccine administration. Has an anticipated need for systemic steroid therapy within 28 days after vaccine administration. Has any evidence of active infections. Is pregnant. Has a history of another cancer (other than pancreatic cancer) or myeloproliferative disorders in the past five years except for treated non-melanoma skin cancer, superficial bladder cancer, or carcinoma in-situ of the cervix. Has a history of noncompliance during previous vaccination cycles with study treatment and/or monitoring which is concerning for continued noncompliance.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lei Zheng, MD

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Data entry and analysis is still ongoing.

Learn more about this trial

A Trial of Boost Vaccinations of Pancreatic Tumor Cell Vaccine

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