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GVAX Pancreas Vaccine With or Without CRS-207 for Advanced Pancreatic Cancer

Information source: National Institutes of Health Clinical Center (CC)
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pancreatic Cancer; Neoplasms, Pancreatic; Pancreatic Neoplasms

Intervention: Cyclophosphamide (Drug); GVAX Pancreas Vaccine (Biological); CRS-207 (Biological)

Phase: Phase 2

Status: Recruiting

Sponsored by: National Cancer Institute, Audro BioTech

Overall contact:
NCI Referral Office, Phone: 1-888-NCI-1937

Summary

Background:

- The GVAX pancreas vaccine is made from pancreatic cancer cells. The cells are changed

in a laboratory to make a protein that helps to activate the immune system cells to recognize and attack the cancer cells. The vaccine will be given as six injections (shots) under the skin. This vaccine is experimental and it is not yet known if it will be helpful to patients with pancreatic cancer.

- CRS-207 is a weakened form of the Listeria bacteria commonly found in the environment

(called wild-type ). Wild-type Listeria can sometimes cause food poisoning and other infections. The bacteria in CRS-207 have been modified to help stimulate the immune system without causing infection.

Objectives:

- To test the safety and effectiveness of the GVAX pancreas vaccine with low doses of

cyclophosphamide and CRS-207.

Eligibility:

INCLUSION CRITERIA:

- Have histologically proven malignant adenocarcinoma of the pancreas

- Locally advanced disease may have non-evaluable disease

- Be at least 18 years of age

- Have an Eastern Cooperative Oncology Group performance status of 0-1

- Have an anticipated life expectancy of greater than 12 weeks

EXCLUSION CRITERIA:

- No history or evidence of brain metastases

- No allergy to both penicillin and sulfa

- No artificial joint or implant ( dental, breast, and portacaths are allowed if no

history of infection or adverse events with implants)

- No history of HIV, hepatitis B or hepatitis C

- No history of active autoimmune disease or history of autoimmune disease requiring

steroids or immunosuppressive treatment.

- No unhealed surgical wounds

- At least 28 days post surgery, steroids or investigational products.

Design:

- Participants will be screened with a physical exam and medical history. They will also

have blood and urine tests, and imaging studies.

- Participants will be in one of two treatment groups. One group will have two doses of

GVAX pancreas vaccine and chemotherapy. This will be followed by four doses of CRS-207. The other group will have six doses of GVAX pancreas vaccine with chemotherapy and no CRS-207.

- Everyone in the study will have the GVAX pancreas vaccine and chemotherapy at weeks 1

and 4 of the study. Treatment will be monitored with frequent regular tests and imaging studies.

- The first treatment group will receive CRS-207 infusions at Week 7. Infusions will be

given in weeks 7, 10, 13, and 16. Participants may need to take antibiotics at certain points during CRS-207 treatment to help clear the drug from the system.

- The second treatment group will have the vaccine and chemotherapy only at weeks 7, 10,

13, and 16.

- Participants will have a final followup exam at Week 20, with a physical exam, blood

tests, and imaging studies.

Clinical Details

Official title: A Phase 2, Randomized, Multicenter, Open-Label Study of the Efficacy and Immune Response of the Sequential Adminstration of GVAX Pancreas Vaccine (With Cyclophosphamide) Alone or Followed by CRS-207 in Adults With Metastatic Pancreatic Adenocarcinoma

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To compare median overall survival in subjects receiving sequential administration of cyclophosphamide, GVAX pancreas vaccine and CRS-207 with median overall survival in subjects receiving cyclophosphamide and GVAX vaccine alone

Secondary outcome: To estimate median overall survivall in subjects receiving test treatments. To assess safety of the treatment regimen

Detailed description: Background

Exocrine pancreatic cancers account for approximately 2% of new cancers diagnosed each year in the United States, and this disease is the fourth leading cause of cancer death for men and women. Patients with local disease who undergo surgical resection (approximately 10% to 15% of all pancreatic carcinoma patients) have an estimated median survival of approximately 18 months, and approximately 20% of patients survive for 5 years. Over 80% of pancreatic cancers are not diagnosed until regional or distant disease is present and patients are no longer amenable to surgical resection. Patients with metastatic disease have an estimated survival of only 3 to 6 months, and the 5-year survival rate after diagnosis in this cohort is less than 5%.

Objectives

Primary:

- To compare median overall survival in subjects receiving sequential administration of

cyclophosphamide, GVAX pancreas vaccine and CRS-207 with median overall survival in subjects receiving cyclophosphamide and GVAX vaccine alone

Secondary:

- To estimate median overall survival in subjects receiving test treatments

- To assess safety of the cyclophosphamide, GVAX pancreas vaccine, and CRS-207 treatment

regimen

Exploratory:

- To assess the association of Listeria monocytogenes (Lm) and mesothelin-specific T-cell

and other immunological responses with overall survival in subjects receiving test treatments

- To evaluate overall response rate in subjects receiving test treatments

- To measure tumor marker kinetics in subjects receiving test treatments

Eligibility

INCLUSION CRITERIA:

- Have histologically proven malignant adenocarcinoma of the pancreas

- Locally advanced disease may have non-evaluable disease

- Be at least 18 years of age

- Have an Eastern Cooperative Oncology Group performance status of 0-1

- Have an anticipated life expectancy of greater than 12 weeks

EXCLUSION CRITERIA:

- No history or evidence of brain metastases

- No allergy to both penicillin and sulfa

- No artificial joint or implant ( dental, breast, and portacaths are allowed if no

history of infection or adverse events with implants)

- No history of HIV, hepatitis B or hepatitis C

- No history of active autoimmune disease or history of autoimmune disease requiring

steroids or immunosuppressive treatment.

- No unhealed surgical wounds

- At least 28 days post surgery, steroids or investigational products.

Design

The study is an open-label, randomized, multicenter clinical study in subjects with metastatic pancreatic adenocarcinoma who have received or refused at least one chemotherapy treatment.

At least 90 subjects will be enrolled and randomized in a 2: 1 fashion into two treatment arms. The randomization will be stratified by disease status (progressive or stable). Both treatment arms will receive up to six doses of vaccine 3 weeks apart (one cycle). Treatment Arm A will receive two doses of cyclophosphamide and GVAX pancreas vaccine and up to four doses of CRS-207. Treatment Arm B will receive up to six doses of cyclophosphamide and GVAX pancreas vaccine.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

- INCLUSION CRITERIA:

- Have histologically proven malignant adenocarcinoma of the pancreas

- Locally advanced disease may have non-evaluable disease

- Be at least 18 years of age

- Have an Eastern Cooperative Oncology Group performance status of 0-1

- Have an anticipated life expectancy of greater than 12 weeks

EXCLUSION CRITERIA:

- No history or evidence of brain metastases

- No allergy to both penicillin and sulfa

- No artificial joint or implant ( dental, breast, and portacaths are allowed if no

history of infection or adverse events with implants)

- No history of HIV, hepatitis B or hepatitis C

- No history of active autoimmune disease or history of autoimmune disease requiring

steroids or immunosuppressive treatment.

- No unhealed surgical wounds

- At least 28 days post surgery, steroids or investigational products.

Locations and Contacts

NCI Referral Office, Phone: 1-888-NCI-1937

The Sidney Kimmel Cancer Center at John Hopkins, Baltimore, Maryland, United States; Recruiting

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland 20892, United States; Recruiting

Additional Information

NIH Clinical Center Detailed Web Page

Related publications:

Sener SF, Fremgen A, Menck HR, Winchester DP. Pancreatic cancer: a report of treatment and survival trends for 100,313 patients diagnosed from 1985-1995, using the National Cancer Database. J Am Coll Surg. 1999 Jul;189(1):1-7.

Burris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, Stephens CD, Von Hoff DD. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997 Jun;15(6):2403-13.

Friberg G, Kindler HL. Chemotherapy for advanced pancreatic cancer: past, present, and future. Curr Oncol Rep. 2005 May;7(3):186-95. Review.

Starting date: September 2011
Last updated: December 7, 2011

Page last updated: December 08, 2011

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