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AzTrials

Pancreatic CancerPhase 1NCT00837135

GI-4000 With Adoptive Transfer in Pancreatic Cancer

A Phase 1 study testing Screening, GI-4000 Vaccine and GI-4000 Vaccine + Activated T Cells in people with Pancreatic Cancer, run by University of Pennsylvania.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Screening, GI-4000 Vaccine and GI-4000 Vaccine + Activated T Cells
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2008to Oct 2009
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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

About this study

Official title: Pilot Study Of Safety And Feasibility Of GI-4000, An Inactivated Recombinant Saccharomyces Cerevisiae Expressing Mutant Ras Protein Combined With Adoptive Transfer And Chemoradiation in Locally Advanced Pancreatic Cancer

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. GI-4000 Vaccination: The first involves a "vaccine," which is an injection (shot) that teaches your immune system to attack foreign invaders. The vaccine we will use is called "GI-4000" - a vaccine composed of yeast that is made to carry the same proteins (called "mutated Ras proteins") found in some pancreatic cancer cells.
  2. Adoptive T-cell Transfer:
Read more

The second type of immunotherapy in this study is called "adoptive T-cell transfer." This involves collecting a specific type of white blood cells from you (called "T-cells")and growing T-cells grown in a lab which may help the research participants' immune systems recover more quickly after chemotherapy, and possibly improved response to other immunotherapies.

We hope that studying these agents together will teach us how to help the immune system fight pancreatic cancer.

Read the detailed description

This Phase I/Pilot study will assess the safety and feasibility of the GI-4000 series vaccine with or without adoptive T cell transfer in subjects with locally advanced pancreatic cancer undergoing chemotherapy, radiotherapy, and surgical resection. Subjects will be randomized to either ARM A (GI-4000vaccine) or ARM B (GI-4000 vaccine and activated T cell transfer). All subjects will undergo apheresis of mononuclear cells immediately before receiving four cycles of gemcitabine/oxaliplatin (GemOx) chemotherapy ("immune preservation phase"). After the completion of chemotherapy, the apheresis product will be reinfused, and the subjects will enter the "priming phase," in which two biweekly doses (dose #1 and #2) of the appropriate GI-4000 vaccine (the one that best matches the mutations found in the patient's tumor) and a single dose of the Prevnar pneumococcal conjugate vaccine will be administered. At this time, those subjects who have not developed distant metastatic disease by CT/MRI will undergo chemoradiation, with ARM B subjects receiving a second apheresis immediately prior to the initiation of the chemoradiation. The pheresed product will be activated and expanded ex vivo and reinfused after chemoradiation is completed. All subjects will receive two more biweekly boosts of the GI-4000 vaccine (doses #3 and #4) while undergoing restaging with CT/MRI ("boosting phase"). Those who have not developed metastatic disease will undergo surgical evaluation for tumor resection. Patients who undergo R0 or R1 resection will receive up to three more weekly doses of GI-4000 prior to the initiation of adjuvant gemcitabine, monthly doses of GI-4000 during the four cycles of gemcitabine chemotherapy, and monthly GI-4000 doses thereafter. At the end of gemcitabine chemotherapy, apheresis will be performed for endpoint correlative studies. Those who are not candidates for surgery or whose tumors are not completely resected will continue to receive GI-4000 monthly booster vaccination.

Being tested
Screening, GI-4000 Vaccine, GI-4000 Vaccine + Activated T Cells, Surgical Evaluation after Vaccine #4
Keywords
Pancreatic Cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ScreeningOther

    1. SCREENING
    2. Consent
    3. Disease Evaluation (CT Scan/MRI; EGC/EUS; Laparoscopy)
    4. Physical Exam, History, Blood Tests
    5. Skin Test (for allergy to saccaromyces cerevisiae) yeast.
    6. Collection of Blood for research
    7. CHEMOTHERAPY AND RADIATION (as determined by Doctor)
    8. ENROLLMENT INTO ACTIVE PART OF STUDY
    9. Consent
    10. Chemotherapy
    11. GI-4000 Vaccine #1 + Prevnar + Activated T Cells
    12. GI-4000 Vaccine #2
    13. 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.

  • GI-4000 VaccineBiological

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

  • GI-4000 Vaccine + Activated T CellsBiological

    Also called GI 4000 Vaccine, Activated T Cells

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

  • Surgical Evaluation after Vaccine #4Biological

    Also called GI-4000 Vaccine

    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.

    1. 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.
Study groups in NCT00837135
Study groupRoleWhat they receive
All SubjectsExperimentalScreening for Eligibility into Trial
Receives: Other: Screening
ARM AExperimentalGI-4000 Vaccine
Receives: Biological: GI-4000 Vaccine
ARM BExperimentalGI-4000 Vaccine + Activated T Cells
Receives: Biological: GI-4000 Vaccine + Activated T Cells
After GI-4000 Vaccine #4ExperimentalGI-4000 Monthly - For those with incomplete removal of tumor GI-4000 Monthly + Chemotherapy - For those with complete removal of tumor
Receives: Biological: Surgical Evaluation after Vaccine #4

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2009 (estimated)
  2. Study startJan 2008
  3. Primary completionOct 2009 (estimated)
  4. Study completionOct 2009 (estimated)

Why it stopped: Withdrawn due to transfer of Investigator

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00837135
Sponsor's protocol ID
806693
Other IDs
UPCC 03207
Status last verified
Aug 2016
First submitted
4 Feb 2009
Last updated
17 Aug 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Screening, GI-4000 Vaccine and GI-4000 Vaccine + Activated T Cells in people with Pancreatic Cancer, run by University of Pennsylvania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00837135.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2016.

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