Vaccine Therapy Combined With Adjuvant Chemoradiotherapy in Treating Patients With Resected Stage I or Stage II Adenocarcinoma (Cancer) of the Pancreas

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Brief Title

Vaccine Therapy Combined With Adjuvant Chemoradiotherapy in Treating Patients With Resected Stage I or Stage II Adenocarcinoma (Cancer) of the Pancreas

Official Title

A Safety and Efficacy Trial of Lethally Irradiated Allogeneic Pancreatic Tumor Cells Transfected With the GM-CSF Gene in Combination With Adjuvant Chemoradiotherapy for the Treatment of Adenocarcinoma of the Pancreas

Brief Summary

      RATIONALE: Vaccines made from gene-modified pancreatic cancer cells may make the body build
      an immune response to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil,
      work in different ways to stop tumor cells from dividing so they stop growing or die.
      Radiation therapy uses high-energy x-rays to damage tumor cells. Giving vaccine therapy
      together with chemotherapy and radiation therapy after surgery may kill any remaining tumor
      cells.

      PURPOSE: This phase II trial is studying how well giving vaccine therapy together with
      adjuvant chemoradiotherapy works in treating patients with resected stage I or stage II
      adenocarcinoma (cancer) of the pancreas.
    

Detailed Description

      OBJECTIVES:

      Primary

        -  Determine overall and disease-free survival of patients with resected stage I or II
           adenocarcinoma of the pancreas treated with adjuvant chemoradiotherapy in combination
           with GVAX pancreatic cancer vaccine.

      Secondary

        -  Correlate specific in vivo parameters of immune response (post-vaccination delayed-type
           hypersensitivity reactions to autologous tumor, mesothelin-specific T-cell response, and
           the degree of local eosinophil, macrophage, and T-cell infiltration at the vaccine site)
           with clinical responses in patients treated with this regimen.

        -  Determine the toxic effects associated with intradermal injections of this vaccine in
           these patients.

      OUTLINE: This is an open-label study.

        -  Post surgery vaccination: Within 8-10 weeks after pancreaticoduodenectomy, patients
           receive GVAX pancreatic cancer vaccine intradermally (ID) on day 0.

        -  Adjuvant chemoradiotherapy: Within 16-28 days after the first vaccination, patients
           receive fluorouracil (5-FU) IV continuously for 3 weeks. Approximately 1-2 weeks after
           completion of 5-FU, patients receive chemoradiotherapy comprising radiotherapy daily and
           5-FU IV continuously for 26-28 weeks. Approximately 3-5 weeks after completion of
           chemoradiotherapy, patients receive 5-FU IV continuously for 4 weeks. 5-FU repeats every
           6 weeks for 2 courses.

        -  Post chemoradiotherapy vaccination: Within 4-8 weeks after the completion of
           chemoradiotherapy, patients receive GVAX pancreatic cancer vaccine ID on days 0, 28, 56,
           and 196.

      Treatment continues in the absence of unacceptable toxicity.

      Patients are followed every 3 months for 1 year and then every 6 months thereafter.

      PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Overall Survival

Secondary Outcome

 To Further Identify and Characterize Toxicities Associated With Intradermal Injections of the Vaccine That Were Initially Reported in the Phase 1 Trial.

Condition

Pancreatic Cancer

Intervention

GVAX pancreatic cancer vaccine

Study Arms / Comparison Groups

 GVAX pancreatic cancer vaccine
Description:  5E8 vaccine cells. The first vaccination is administered 6-8 weeks after surgery. Four to eight weeks following the completion of the last cycle of adjuvant radiation and chemotherapy (chemo-radiation therapy is standard of care and not part of the protocol) eligible patients will receive three additional vaccinations at one month intervals. Patients who continue to remain disease-free will receive a fifth "booster" vaccination, six months following the fourth vaccination

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

60

Start Date

January 2002

Completion Date

July 2006

Primary Completion Date

December 2005

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed invasive ductal adenocarcinoma of the head, neck, and
             uncinate process of the pancreas

               -  Mixed adenocarcinoma tumors allowed if the predominant invasive component of the
                  tumor is adenocarcinoma

               -  Stage I or II (clinical stage T1-3, N0-1, M0) disease

          -  Has undergone pancreaticoduodenectomy at the Johns Hopkins Hospital within the past
             8-10 weeks

               -  Completely resected (R0) or microscopic residual (R1) disease

          -  No diagnosis other than ductal adenocarcinoma, including any of the following:

               -  Adenosquamous

               -  Squamous cell

               -  Colloid

               -  Islet cell

               -  Non-invasive intraductal papillary mucinous neoplasms

               -  Serous or mucinous cystadenoma or cystadenocarcinoma

               -  Carcinoid

               -  Small or large cell carcinoma

               -  Intraductal oncocytic papillary neoplasms

               -  Osteoclast-like giant cell tumors

               -  Acinar cell carcinoma

               -  Pancreatoblastoma

               -  Solid pseudopapillary tumors

               -  Undifferentiated small cell carcinoma

               -  Non-epithelial tumors (sarcoma, gastrointestinal stromal tumor, or lymphoma)

               -  Adenocarcinoma of the ampulla

               -  Adenocarcinoma of the distal bile duct

               -  Adenocarcinoma of the duodenum

          -  No recurrent disease

          -  No metastatic disease, including peritoneal implants or liver and/or lung involvement

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count >/= 1,500/mm^3

          -  Platelet count >/= 100,000/mm^3

          -  Hemoglobin >/= 10 g/dL

        Hepatic

          -  Bilirubin /= 1,500
             calories/day, ongoing requirement for long-term biliary stenting, or persistence of
             wound infection)

          -  No other malignancy within the past 5 years except nonmelanoma skin cancer

          -  No uncontrolled medical conditions that would preclude study participation

          -  No other major active medical or psychosocial problem that could be exacerbated by
             study treatment

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for at least 4 weeks
             after study participation

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  More than 1 month since prior biologic therapy

          -  No other concurrent biologic therapy, immunotherapy, or gene therapy for pancreatic
             cancer

        Chemotherapy

          -  More than 1 month since prior chemotherapy

          -  No other concurrent chemotherapy for pancreatic cancer

        Endocrine therapy

          -  More than 28 days since prior systemic steroids

          -  No concurrent systemic corticosteroids

        Radiotherapy

          -  More than 1 month since prior radiotherapy

          -  No other concurrent radiotherapy for pancreatic cancer

        Surgery

          -  See Disease Characteristics

          -  Recovered from prior surgery

        Other

          -  More than 1 month since prior participation in an investigational new drug trial

          -  No other concurrent investigational therapy for pancreatic cancer
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Daniel A. Laheru, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00084383

Organization ID

J9988

Secondary IDs

R01CA088058

Responsible Party

Sponsor

Study Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Daniel A. Laheru, MD, Principal Investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins


Verification Date

July 2013