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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


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

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Trial Information

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

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with adverse events as a measure of toxicity

Outcome Description:

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

Outcome Time Frame:

4 years

Safety Issue:

Yes

Principal Investigator

Joseph Herman, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Authority:

United States: Food and Drug Administration

Study ID:

J1179

NCT ID:

NCT01595321

Start Date:

August 2012

Completion Date:

July 2016

Related Keywords:

  • Pancreatic Cancer
  • Adjuvant therapy
  • Immunotherapy
  • Cytoxan
  • Cyclophosphamide
  • Pancreatic Vaccine
  • Stereotactic radiation therapy
  • SBRT
  • FOLFIRINOX
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms

Name

Location

The Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231