Completed

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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What is being tested

GVAX pancreatic cancer vaccine

Biological
Who is being recruted

Pancreatic Cancer

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2002

See protocol details

Summary

Principal SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last updated: July 22, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2002Actual date on which the first participant was enrolled.

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. 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.

Official TitleA 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 
Principal SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last updated: July 22, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
60 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Pancreatic Cancer
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 \</= 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 * Sjogren'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 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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
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
Study Objectives
Primary Objectives

Overall survival in patients treated with adjuvant chemoradiotherapy in sequence with the irradiated allogeneic GM-CSF transfected pancreatic tumor cell lines. Overall survival is defined as time from surgery until death, regardless of cause.

Disease-free Survival in Patients Treated With Adjuvant Chemoradiotherapy in Sequence With the Irradiated Allogeneic GM-CSF Transfected Pancreatic Tumor Cell Lines. DFS is defined as time from surgery until clinical evidence of disease (eg, CT scan) or death due to any cause.
Secondary Objectives

The specific immune parameters include: post-vaccination delayed type hypersensitivity reactions to autologous tumor and the degree of local eosinophil, macrophage, and T cell infiltration at the vaccine site, and mesothelin-specific T cell responses.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, United StatesSee the location
CompletedOne Study Center