Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	JHOC-J9988 NCT00084383

Special Category: SPORE trial

Objectives

Primary

1. 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

1. 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.
2. Determine the toxic effects associated with intradermal injections of this vaccine in these patients.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10 g/dL

Hepatic

• Bilirubin ≤ 2 mg/dL
• AST/ALT ≤ 2 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 5 times ULN

Renal

• Creatinine ≤ 2 mg/dL

Pulmonary

• No asthma or chronic obstructive pulmonary disease requiring systemic corticosteroids

Immunologic

• HIV negative
• No active infection
• No prior or concurrent autoimmune disease requiring treatment with systemic immunosuppressants, including any of the following:
  • Inflammatory bowel disease
  • Systemic vasculitis
  • Scleroderma
  • Psoriasis
  • Multiple sclerosis
  • Hemolytic anemia or immune thrombocytopenia
  • Rheumatoid arthritis
  • Systemic lupus erythematosus
  • Sjögren's syndrome
  • Sarcoidosis
• Negative results to viral delayed-type hypersensitivity serology testing if autologous tumor cells are available

Other

• No postoperative complications (e.g., inability to take oral nutrition ≥ 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Daniel Laheru, MD, Principal investigator		Ph: 410-955-8974

Registry Information
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
Trial Start Date		2002-01-30
Registered in ClinicalTrials.gov		NCT00084383
Date Submitted to PDQ		2003-10-20
Information Last Verified		2005-06-01
NCI Grant/Contract Number		P30-CA06973, R01-CA88058

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