Pancreatic Tumor Cell Vaccine (GVAX), Low Dose Cyclophosphamide, Fractionated Stereotactic Body Radiation Therapy (SBRT), and FOLFIRINOX Chemotherapy in Patients With Resected Adenocarcinoma of the Pancreas

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01595321
• Collaborator: The Skip Viragh Foundation (Other)
• Enrollment: 19
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 142.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to estimate safety of a whole cell vaccine with immune modulating doses of cyclophosphamide followed by SBRT and FOLFIRINOX chemotherapy in pancreatic cancer patients after surgery.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Drug: Cyclophosphamide; Biological: PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccine; Radiation: Stereotactic Body Radiation (SBRT); Drug: FOLFIRINOX	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Study Evaluating An Allogeneic GM-CSF-Transduced Pancreatic Tumor Cell Vaccine (GVAX) and Low Dose Cyclophosphamide Integrated With Fractionated Stereotactic Body Radiation Therapy (SBRT) and FOLFIRINOX Chemotherapy in Patients With Resected Adenocarcinoma of the Pancreas
• Actual Study Start Date: Oct 29, 2012
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SBRT and FOLFIRINOX The first 6 patients will receive SBRT and FOLFIRINOX only.	Radiation: Stereotactic Body Radiation (SBRT); SBRT (6.6 Gy) will be administered over 5 days starting between 13-17 days after the first vaccine dose (Arm 2) or within 6-10 weeks of surgery (Arm 1).; Drug: FOLFIRINOX; FOLFIRINOX will be administered over 6 cycles starting at least 14 days after SBRT (Arms 1 and 2) and at least 28 days after the first vaccine (Arm 2).; Other Names: Oxaliplatin Irinotecan Leucovorin Fluorouracil
Experimental: Cyclophosphamide, Vaccine, SBRT, and FOLFIRINOX The last 12 patients will receive cyclophosphamide, Vaccine, SBRT, and FOLFIRINOX.	Drug: Cyclophosphamide; Cyclophosphamide 200 mg/m2 will be administered one day prior to vaccination (day 0). One dose will be given prior to SBRT and FOLFIRINOX and four additional doses after FOLFIRINOX completion for a total of 5 doses. Additional Cy-vaccine boosts may be given every 6 months thereafter until disease recurrence.; Other Names: Cytoxan ; Biological: PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccine; Vaccine will be administered one day after cyclophosphamide (day 1). One dose will be given prior to SBRT and FOLFIRINOX and four additional doses after FOLFIRINOX completion for a total of 5 doses. Additional Cy-vaccine boosts may be given every 6 months thereafter until disease recurrence.; Other Names: Pancreatic cancer vaccine ; Radiation: Stereotactic Body Radiation (SBRT); SBRT (6.6 Gy) will be administered over 5 days starting between 13-17 days after the first vaccine dose (Arm 2) or within 6-10 weeks of surgery (Arm 1).; Drug: FOLFIRINOX; FOLFIRINOX will be administered over 6 cycles starting at least 14 days after SBRT (Arms 1 and 2) and at least 28 days after the first vaccine (Arm 2).; Other Names: Oxaliplatin Irinotecan Leucovorin Fluorouracil

Outcome Measures

Primary Outcome Measures

1. Number of participants with adverse events as a measure of toxicity [4 years]

   To determine the safety profile of the whole cell vaccine (GVAX) administered along with cyclophosphamide; fractionated SBRT, and FOLFIRINOX.

Secondary Outcome Measures

1. Survival [4 years]

   To estimate the median overall survival (OS), disease-free survival (DFS), and distant metastases free survival (DMFS) using Kaplan-Meier techniques.

2. Time to disease progression using immune correlates [4 years]

   Correlate progression with the immune response through vaccine-induced changes in the number, function, avidity, size and diversity of the mesothelin-specific T cell repertoire).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 76 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria (abbreviated):

1. Documented cancer of the pancreas (head, neck, and/or uncinate process), that has been completely resected

2. No prior Chemotherapy, radiation therapy or biologic therapy for pancreatic cancer

3. Must be within 10 weeks from surgical resection of cancer

4. Titanium clips (minimum 1) must be placed at the time of surgery to aid in SBRT treatment planning

5. ECOG Performance Status of 0 to 1

6. Adequate organ function as defined by study-specified laboratory tests

7. Must use acceptable form of birth control through the study and for 28 days after final dose of study drug

8. Signed informed consent form

9. Willing and able to comply with study procedures

Exclusion criteria (abbreviated):

1. Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions

2. Presence of metastatic disease

3. Clinical metabolic or laboratory abnormalities defined as Grade 3 or 4 of the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0

4. Systemically active steroids

5. Chemotherapy, radiation therapy or biologic therapy within 28 days prior to receiving study drug

6. Inability to begin protocol treatment within 70 days (10 weeks) after surgery to remove cancer

7. History of HIV, hepatitis B or C infection

8. Pregnant or lactating

9. Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Daniel Laheru, M.D., The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• ClinicalTrials.gov Identifier: NCT01595321
• Other Study ID Numbers: J1179; NA_00050233
• First Posted: May 10, 2012
• Last Update Posted: Mar 4, 2022
• Last Verified: Mar 1, 2022

• Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: Adjuvant therapy; Immunotherapy; Cytoxan; Cyclophosphamide; Pancreatic Vaccine; Stereotactic radiation therapy; SBRT; FOLFIRINOX
• Additional relevant MeSH terms: Adenocarcinoma; Pancreatic Neoplasms; Leucovorin; Cyclophosphamide; Fluorouracil; Oxaliplatin; Irinotecan; Folfirinox; Vaccines

Study Results

No Results Posted as of Mar 4, 2022