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Locally Advanced Pancreatic AdenocarcinomaPhase 1NCT01342224

Immunochemoradiotherapy in Patients With Pancreatic Cancer

A Phase 1 study testing tadalafil and vaccination in people with Locally Advanced Pancreatic Adenocarcinoma, run by Providence Health & Services at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will add an immunotherapy component to chemotherapy and radiation treatment in patients who have pancreatic cancer. The objective of this study is to see if the combined treatment is safe and feasible, and if a larger study is warranted. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
tadalafil and vaccination
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
Jan 2011to Apr 2018
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

  • Pancreatic adenocarcinoma proven by biopsy or cytology Locally advanced, unresectable disease with absence of distant metastatic disease. The presence of non-regional retroperitoneal or abdominal adenopathy is acceptable for inclusion.
  • OR
  • Borderline resectable pancreatic adenocarcinoma (any of the following):
  • Tumor abutment or encasement of a short segment of hepatic artery (without evidence of tumor extension to the celiac artery) that is amenable to resection and reconstruction
  • Tumor abutment of the superior mesenteric artery involving 180 degrees or less of the circumference of the artery and without encasement
  • Impingement or narrowing of the superior mesenteric vein/portal vein or short-segment (< 2 cm) occlusion of the superior mesenteric vein, portal vein, or their confluence with a suitable option for vascular reconstruction
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  • Eastern Cooperative Oncology Group(ECOG)Performance Status 0 or 1
  • Ability to give informed consent and comply with the protocol
  • Women of childbearing potential must have a negative pregnancy test and must avoid becoming pregnant while on treatment. Men must avoid fathering a child while on treatment.
  • Patients with a history of psychiatric illness must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy.

Who cannot join

  • Age < 18 years
  • History of other malignancy in the past 2 years except carcinoma in situ of the cervix or bladder, or non-melanomatous skin cancer
  • Previous chemotherapy or radiation therapy for pancreatic cancer or previous radiation therapy to the target field
  • Clinically active autoimmune disease or active infection
  • History of heart attack (within 90 days) or stroke (within 6 months), or presence of hypertension requiring change in blood pressure medications in the last 4 weeks, hypotension, uncontrolled arrhythmias, heart failure (New York Heart Association (NYHA) Functional Classification ≥ Class 2 in last 6 months), unstable angina or angina occurring during sexual activity.
  • Use of "nitrates" or nitroglycerin.
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  • History of hereditary degenerative retinal disorders including retinitis pigmentosa.
  • Chronic systemic corticosteroid use at supra-physiologic doses (prednisone > 10 mg a day or equivalent)
  • Use of recreational drugs called "poppers" like amyl nitrite and butyl nitrite.
  • Laboratory values (performed within 14 days prior to enrollment) as follows:
  • Neutrophil count < 1500 cells/µL
  • Hemoglobin < 9 gm/dL (patients may be transfused to establish eligibility)
  • Platelet count < 100,000 cells/µL
  • Significant coagulopathy (INR > 1.5)
  • Significant liver or renal dysfunction
  • Other medical or psychiatric conditions that in the opinion of the Principal Investigator would preclude safe participation in protocol.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Providence Health & Services

    Portland, Oregon, 97213

Other trials in United States

About this study

Official title: Exploratory Trial of Immunochemoradiotherapy for Locally Advanced Pancreatic Adenocarcinoma

This study will add an immunotherapy component to chemotherapy and radiation treatment in patients who have pancreatic cancer. The objective of this study is to see if the combined treatment is safe and feasible, and if a larger study is warranted.

Read the detailed description

All study participants receive an initial 4 week course of intra-dermal vaccination with telomerase vaccine (GV1001) and immune adjuvant, granulocyte macrophage colony-stimulating factor (GM-CSF), along with a cycle of gemcitabine chemotherapy. This is followed by concurrent radiation therapy and low-dose intravenous (IV) gemcitabine chemotherapy given twice weekly followed by one additional dose of vaccine.

About 4 weeks (as late as 8 weeks) after chemotherapy and radiation treatment, participants with disease that can be removed by surgery will proceed to surgery. After recovery, immunochemotherapy will resume.

Participants with stable or responsive disease that is not able to be treated with surgery will proceed to immunochemotherapy.

Immunochemotherapy will consist of 2 cycles of telomerase vaccine with GM-CSF along with gemcitabine chemotherapy. Participants with disease that is not able to be treated with surgery, or that has worsened following immunochemoradiotherapy phase of treatment may continue on study with transition to immunochemotherapy phase of treatment. Tadalafil will be administered orally on a daily basis from start of therapy (Day 1) through completion of therapy with doses held only when required in the immediate perioperative period in patients who proceed to surgery.

Being tested
tadalafil and vaccination
Keywords
pancreatic, cancer, adenocarcinoma, vaccine
Medical subject headings
Neoplasms, Adenocarcinoma

What participants receive

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

  • tadalafil and vaccinationBiological

    Also called tadalafil: Cialis, gemcitabine: Gemzar, telomerase vaccine: GV1001, GM-CSF: Sargramostim (Leukine)

    Participants receive a 4-week course of vaccination with telomerase vaccine and GM-CSF by injection, along with a cycle of gemcitabine chemotherapy (IV). This is followed by radiation and gemcitabine given twice weekly then by another dose of vaccine. Four weeks after completion of chemotherapy and radiation, participants able to have surgical treatment will have surgery followed by vaccination and chemotherapy. Participants with stable or responsive disease that cannot be treated by surgery will have vaccination and chemotherapy with 2 cycles of telomerase vaccine with GM-CSF along with gemcitabine. Participants with unresectable and progressive disease after administration of vaccine, chemotherapy and radiation treatment may transition to vaccination and chemotherapy treatment.

Study groups in NCT01342224
Study groupRoleWhat they receive
tadalafil and vaccinationExperimentalParticipants receive a 4-week course of vaccination with telomerase vaccine and GM-CSF by injection, along with a cycle of gemcitabine chemotherapy (IV). This is followed by radiation and gemcitabine given twice weekly then by another dose of vaccine.
Receives: Biological: tadalafil and vaccination

What is being measured

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

  1. Safety

    Adverse events will be graded no less than weekly for the first 180 days. Post-treatment long-term follow-up will occur every 12 weeks beyond day 180 for 6 visits and then every 24 weeks thereafter until progressive disease, withdrawal from study or death. For this pilot study, adverse events and efficacy measures will be personally reviewed by the principal investigator. Both hematologic and non-hematologic toxicity will be anticipated. In conjunction with the IRB, stopping the trial will be among possible measures taken if undue toxicity or inadequate outcomes are observed.

    Measured: 180 Days

Secondary outcomes (2)

  1. Immune Response

    In patients having surgery: Tumor tissue obtained at the time of surgery will be examined to determine the degree of macrophage and T cell infiltration. In all patients: Multiparameter flow cytometry will determine the frequency of circulating telomerase-specific memory CD8+ T cells in blood samples obtained pre- and post- treatment. Accrual is anticipate to last 10-12 months, so post treatment samples from the last patient enrolled would be available for analysis approximately 18 months after the first patient enrolled.

    Measured: 18 months

  2. Tumor Response

    Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Tumor measurements are made 4 times during the study, the last at 180 days after study enrollment.

    Measured: 180 days

Timeline

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

  1. First posted27 Apr 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionJun 2012
  4. Study completionApr 2018

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01342224
Sponsor's protocol ID
PHS 10-141B
Status last verified
Apr 2018
First submitted
21 Apr 2011
Last updated
12 Apr 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Crocenzi T, Cottam B, Newell P, Wolf RF, Hansen PD, Hammill C, Solhjem MC, To YY, Greathouse A, Tormoen G, Jutric Z, Young K, Bahjat KS, Gough MJ, Crittenden MR. A hypofractionated radiation regimen avoids the lymphopenia associated with neoadjuvant chemoradiation therapy of borderline resectable and locally advanced pancreatic adenocarcinoma. J Immunother Cancer. 2016 Aug 16;4:45. doi: 10.1186/s40425-016-0149-6. eCollection 2016.

    PubMed 27532020

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing tadalafil and vaccination in people with Locally Advanced Pancreatic Adenocarcinoma, run by Providence Health & Services at 1 site in United States.

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 10 inclusion and 16 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: finished, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety (time frame: 180 Days). 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 NCT01342224, which also lists 1 linked publication.

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 12 Apr 2018.

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