Boost GVAX Pancreas Vaccine With or Without CY in Patients With Pancreas Cancer

NCT01088789 | Active Not Recruiting Phase 2 Results DMC

• 2 other identifiers: J09100NA_00031401
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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 (GVAX Pancreas Vaccine) 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 pancreas.

Conditions

Pancreatic Cancer

Keywords

Adenocarcinoma; Cyclophosphamide; Immunotherapy; Adjuvant; Pancreatic tumor vaccine; GM-CSF; GVAX; Cancer vaccine

Outcome Measures

Primary Outcomes (2)

• Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation

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

  121 Months

• Number of Participants Experiencing Grade 3 or Above Drug-Related Adverse Events (AEs)

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

  121 months

Secondary Outcomes (2)

• Disease Free Survival (DFS)

  131 months

• Overall Survival (OS)

  174 Months

Study Arms (7)

Cohort 1 (J0810 Arm A)

EXPERIMENTAL

Patients coming from J0810 (NCT00727441). Patients receive GVAX.

Biological: GVAX Pancreas Vaccine

Cohort 1 (J0810 Arm B)

EXPERIMENTAL

Patients coming from J0810 (NCT00727441). Patients receive IV CY and GVAX.

Drug: Cyclophosphamide; Biological: GVAX Pancreas Vaccine

Cohort 1 (J0810 Arm C)

EXPERIMENTAL

Patients coming from J0810 (NCT00727441). Patients receive oral CY and GVAX.

Drug: Cyclophosphamide Pill; Biological: GVAX Pancreas Vaccine

Cohort 2 (Vaccine Naive)

EXPERIMENTAL

Patients receive IV CY and GVAX.

Drug: Cyclophosphamide; Biological: GVAX Pancreas Vaccine

Cohort 3 (J1568)

EXPERIMENTAL

Patients coming from J1568 (NCT02451982). Patients receive IV CY and GVAX.

Drug: Cyclophosphamide; Biological: GVAX Pancreas Vaccine

Cohort 4 (J15237)

EXPERIMENTAL

Patients coming from J15237 (NCT02648282). Patients receive IV CY and GVAX.

Drug: Cyclophosphamide; Biological: GVAX Pancreas Vaccine

Cohort 5 (J1766)

EXPERIMENTAL

Patients coming from J1766 (NCT03153410). Patients receive IV CY and GVAX.

Drug: Cyclophosphamide; Biological: GVAX Pancreas Vaccine

Interventions

Cyclophosphamide DRUG

Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).

Also known as: CY

Cohort 1 (J0810 Arm B); Cohort 2 (Vaccine Naive); Cohort 3 (J1568); Cohort 4 (J15237); Cohort 5 (J1766)

Cyclophosphamide Pill DRUG

Cohort 1 patients (J0810 Arm C) will receive 50mg oral CY once a day starting 28 days prior to GVAX and for 28 days post-GVAX (every 6 months).

Also known as: CY

Cohort 1 (J0810 Arm C)

GVAX Pancreas Vaccine BIOLOGICAL

Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).

Also known as: Panc 10.05 pcDNA-1/GM-Neo, Panc 6.03 pcDNA-1/GM-Neo

Cohort 1 (J0810 Arm A); Cohort 1 (J0810 Arm B); Cohort 1 (J0810 Arm C); Cohort 2 (Vaccine Naive); Cohort 3 (J1568); Cohort 4 (J15237); Cohort 5 (J1766)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• The Skip Viragh Foundation: collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Adenocarcinoma

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Daniel Laheru, MD
• Organization: SKCCC Johns Hopkins Medical Institution

Laherda@jhmi.edu

410-955-8974

Study Officials

• Daniel Laheru, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 17, 2010
• Study Start: April 20, 2010
• Primary Completion: July 17, 2024
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 26, 2025
• Results First Posted: July 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)