GI-4000 With Adoptive Transfer in Pancreatic Cancer

NCT00837135 | Withdrawn Phase 1

• 2 other identifiers: 806693UPCC 03207
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine if it is safe to add multiple immunotherapies to standard chemotherapy and radiation for treating pancreatic cancer tumors that cannot be completely removed by surgery.

1. 1.GI-4000 Vaccination:
2. 2.Adoptive T-cell Transfer:

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• To evaluate the feasibility of incorporating GI-4000 vaccine and activated T-cell infusion into a regimen of chemotherapy, radiation, and surgical resection to treat locally advanced pancreatic cancer.

  1 year

Study Arms (4)

All Subjects

EXPERIMENTAL

Screening for Eligibility into Trial

Other: Screening

ARM A

EXPERIMENTAL

GI-4000 Vaccine

Biological: GI-4000 Vaccine

ARM B

EXPERIMENTAL

GI-4000 Vaccine + Activated T Cells

Biological: GI-4000 Vaccine + Activated T Cells

After GI-4000 Vaccine #4

EXPERIMENTAL

GI-4000 Monthly - For those with incomplete removal of tumor GI-4000 Monthly + Chemotherapy - For those with complete removal of tumor

Biological: Surgical Evaluation after Vaccine #4

Interventions

Screening OTHER

A. SCREENING 1. Consent 2. Disease Evaluation (CT Scan/MRI; EGC/EUS; Laparoscopy) 3. Physical Exam, History, Blood Tests 4. Skin Test (for allergy to saccaromyces cerevisiae) yeast. 5. Collection of Blood for research B. CHEMOTHERAPY AND RADIATION (as determined by Doctor) C. ENROLLMENT INTO ACTIVE PART OF STUDY 1. Consent 2. Chemotherapy 3. GI-4000 Vaccine #1 + Prevnar + Activated T Cells 4. GI-4000 Vaccine #2 5. Disease Evaluation (CT Scan/MRI). If disease has spread, subject is taken off study. If disease is stable, subject go on to ARM A or ARM B.

All Subjects

GI-4000 Vaccine BIOLOGICAL

1. Chemotherapy and Radiation 2. GI-4000 Vaccine #3 3. GI-4000 Vaccine #4

ARM A

GI-4000 Vaccine + Activated T Cells BIOLOGICAL

1. Apheresis #2 2. Chemoradiation 3. Activated T Cells + GI-4000 Vaccine #3 4. GI-4000 Vaccine #4

Also known as: GI 4000 Vaccine, Activated T Cells

ARM B

Surgical Evaluation after Vaccine #4 BIOLOGICAL

SURGICAL EVALUATION (to determine disease status) A. For those who have complete removal of tumor. These subjects will continue to receive Chemotherapy AND GI-4000 Vaccination Monthly during Chemotherapy. Disease evaluation every 3-6 months (CT Scan/MR. B. For those sucjects who cannot have surgery or who have not had complete removal of tumor. These subjects will continue to have GI-4000 Vaccinations Monthly as long as there is no disease progression. Disease evaluation every 3-6 months (CT Scan/MR.

Also known as: GI-4000 Vaccine

After GI-4000 Vaccine #4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with untreated, locally advanced pancreatic adenocarcinoma that expresses a GI-4000 related k-ras oncoprotein.
• Histologically-confirmed pancreatic adenocarcinoma that expresses one of the GI-4000-related k-ras oncoproteins (G12V, G12C, G12D, Q61L, or Q61R)
• Locally advanced disease, (stages I-III, i.e no evidence of metastasis outside the pancreas and its regional lymph nodes). Preferred subjects for entry into the study are those with borderline resectable disease, as defined by:
• tumor that encases a short segment of the hepatic artery without extension to the celiac axis and that is amenable to resection and reconstruction, OR
• tumor that abuts the superior mesenteric artery and that involves \<180 degrees of the circumference of the artery, OR
• short-segment occlusion of the superior mesenteric vein, portal vein, or their confluence with a suitable option available for vascular reconstruction because the veins are normal above and below the area of tumor involvement.
• Age \>18 years
• ECOG performance status 0 or 1
• Normal organ and bone marrow function as defined by:
• Absolute neutrophil count \> 1,500/μl Platelets \> 100,000/μl AST(SGOT)/ALT(SGPT)\< 2.5 X institutional upper limit of normal Bilirubin \< 2.0 mg/dL unless due to bile duct blockage by tumor Creatinine \< 1.5 x ULN
• A biliary stent 9F or biliary bypass before treatment, if tumor-related biliary obstruction is present
• The ability to sustain adequate hydration and nutrition (\>1500 cal/d) by oral intake or access for supplemental enteral feeding (nasoenteral tube, feeding jejunostomy or PEG)
• Patients must have measurable disease by radiographic imaging, as defined by 1 lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as 20 mm with conventional techniques or 10 mm with spiral CT scanning. Marker elevation alone is insufficient for entry.
• Ability to understand and the willingness to sign a written informed consent documents.
• Adequate venous or catheter access and ability to tolerate apheresis.

You may not qualify if:

• Tumor metastatic to peritoneum, liver or other organs
• Tumor that is clearly resectable for curative intent
• Prior chemotherapy, radiation therapy, targeted therapy, or immunotherapy for pancreatic cancer.
• Receipt of any other investigational agents within 30 days prior to screening
• Known HIV positive
• A major surgical procedure or significant traumatic injury within 28 days prior to anticipated initiation of chemotherapy, an anticipated major surgical procedure during the course of the study, or a minor surgical procedure (laparoscopy, fine needle aspiration, or core biopsy) within 7 days of anticipated initiation of chemotherapy.
• Serious non-healing wounds, ulcers, or bone fractures
• Pregnancy or ongoing breast-feeding, as chemotherapy may pose substantial risk to the fetus/infant.
• Patients whose treatment plan would require treating \>50% of the liver to a dose greater than 30 Gy or treating \> 50% of the total kidney volume to a dose greater than 18 Gy
• Positive scratch test (immediate hypersensitivity, IgE mediated) to S. cerevisiae.
• Active autoimmune disease requiring immunosuppressive therapy

Sponsors & Collaborators

• University of Pennsylvania: lead

Related Links

• Abramson Cancer Center of the University of Pennsylvania

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Peter J. O'Dwyer, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2009
• First Posted: February 5, 2009
• Study Start: January 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: August 17, 2016

Record last verified: 2016-08