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Pancreatic CancerPhase 1NCT00402025

Talimogene Laherparepvec in Patients With Unresectable Pancreatic Cancer

A Phase 1 study testing Talimogene Laherparepvec in people with Pancreatic Cancer, run by BioVex Limited at 3 sites 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

The purpose of the study is to assess the safety of injections of talimogene laherparepvec into patients with pancreatic cancer that cannot be removed by surgery. The study will also test whether the injections are effective in treating the tumor. 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?
Talimogene Laherparepvec
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
3 sitesUnited States
Study dates
Nov 2006to Jan 2008
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • cytological or histological proof of adenocarcinoma of the pancreas
  • unresectable, locally advanced disease (isolated liver metastases are permitted)
  • tumors of at least 1 cm diameter at screening
  • measurable disease using Response Evaluation Criteria In Solid Tumors (RECIST) criteria
  • failure of either standard therapy, OR any one of the following:
  • no alternative therapeutic of higher curative potential is available;
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  • investigator determination that patient could not tolerate alternative therapeutic due to unacceptable toxicity; or,
  • patient refusal to be treated with available alternative therapeutic
  • age > 18 years
  • life expectancy > 3 months
  • adequate bone marrow function as indicated by:
  • White blood cells (WBC) ≥ 3.0 x 10^9/L
  • platelets ≥ 100 x 10^9/L
  • hemoglobin ≥ 8.5 gm/dL
  • adequate liver function as indicated by:
  • bilirubin < 1.5 x upper limit of normal (ULN)
  • alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 5 x ULN in case of presence of liver metastasis
  • ALT or AST < 2.5 x ULN in case of absence of liver metastasis
  • adequate renal function as indicated by a serum creatinine level < 1.5 x ULN.
  • adequate hemostasis indicated by international normalized ratio (INR) ≤ 1.5
  • mentally, physically and geographically able to undergo treatment and follow-up
  • provided written informed consent
  • first patient in each cohort only: seropositive for herpes simplex virus type 1 (HSV1)

Who cannot join

  • history of other malignancy within two years prior to screening, except for prostate cancer (T1c, T2ab with definitive treatment, prostate-specific antigen (PSA) < 1 ng/ml, and without ongoing hormone suppression) or adequately treated in situ carcinoma of the cervix, basal cell carcinoma, or squamous cell carcinoma of the skin
  • cystic form of pancreatic cancer; microcystic disease may be eligible upon discussion with Medical Monitor
  • Common Terminology Criteria for Adverse Events (CTCAE) version 3 grade 2 or greater clinical pancreatitis within 8 weeks prior to dosing with OncoVEX^GM-CSF
  • other than metastases limited to the liver, imaging evidence of metastatic disease to any other organ or tissue
  • any serious concomitant systemic disorder that would compromise the safety of the patient, at the discretion of the investigator
  • evidence of compromised immune function including but not limited to:
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  • clinically significant absolute lymphocyte count < Lower Limit of Normal (LLN)
  • known human immunodeficiency virus (HIV), acute or chronic active hepatitis B, or hepatitis C infection;
  • concurrently taking HIV antiviral medications (e.g. protease inhibitors, azidothymidine, etc.)
  • received intravenous (IV), intramuscular (IM) or subcutaneous (SC) human gamma globulin within 6 months prior to dosing with OncoVEX^GM-CSF
  • patients taking immunosuppressive agents (e.g. cyclosporine, tacrolimus, or oral or systemic corticosteroids at a dose of > 10 mg/day of prednisone or equivalent).
  • pregnancy, lactation or lack of effective contraception in women of child-bearing potential (e.g., not post menopausal for > 2 years, or had tubal ligation); lack of effective contraception in men if the partner is of child-bearing potential; women must have been practicing an effective contraceptive method for at least three months prior to entry in to the trial (hormonal contraception or intrauterine device in conjunction with a barrier method); men must use a condom or be surgically sterilized
  • patients with active bacterial or viral infections that require treatment with systemic antibiotics or antiviral agents within 2 weeks prior to the first dose of OncoVEX^GM-CSF); (note: patients with active cold sores or other HSV1 infections must wait until those lesions have crusted over before receiving OncoVEX^GM-CSF)
  • surgery requiring general or spinal anesthesia within four weeks prior to dosing with OncoVEX^GM-CSF
  • Treatment with an investigational agent within 4 weeks prior to the first dose of OncoVEX^GM-CSF
  • serum carbohydrate antigen (CA)19.9 levels > 3000 U/mL at screening
  • evidence of ascites on screening abdominal computed tomography (CT) scan

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Mary Crowely Medical Research Center

    Dallas, Texas, 75246

  • UCI Medical Center

    Orange, California, 92868

  • California Pacific Medical Center

    San Francisco, California, 94115

Other trials in United States

About this study

Official title: Targeted Delivery of OncoVEX^GM-CSF by Endoscopic Ultrasound (EUS)-Guided Fine Needle Injection (FNI) in Patients With Irresectable Pancreatic Cancer: A Pilot Multinational Experiment on Safety and Proof of Concept

The purpose of the study is to assess the safety of injections of talimogene laherparepvec into patients with pancreatic cancer that cannot be removed by surgery. The study will also test whether the injections are effective in treating the tumor.

Read the detailed description

Talimogene laherparepvec is a conditionally replication competent herpes simplex type-1 virus designed for use in solid tumors. It has been specifically modified to replicate in tumors and to provide a local source of the immune-stimulating cytokine, granulocyte macrophage colony stimulating factor (GM-CSF). It is injected directly into cancer tumors and is believed to destroy tumor cells by direct infection of the tumor cells and an enhanced immune response due to the release of tumor antigens and GM-CSF expression.

This was an open-label, dose-escalation study evaluating the safety and efficacy of talimogene laherparepvec administered by direct injection into pancreatic tumors using endoscopic ultrasound (EUS)-guided fine needle injection (FNI). Only 1 tumor mass within the body and tail of the pancreas was injected in any participant. The protocol called for evaluation of 4 dosing regimens in sequential cohorts of participants; however, cohort 4 was not opened for enrollment.

Being tested
Talimogene Laherparepvec
Keywords
Metastatic, Pancreas, Adenocarcinoma
Medical subject headings
Pancreatic Neoplasms, Neoplasm Metastasis, Adenocarcinoma

What participants receive

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

  • Talimogene LaherparepvecBiological

    Also called OncoVEX^GM-CSF, T-VEC, IMLYGIC

    Talimogene laherparepvec administered by direct injection into pancreatic tumors using EUS-guided FNI, up to a maximum of 4 mL per treatment.

Study groups in NCT00402025
Study groupRoleWhat they receive
Talimogene LaherparepvecExperimentalParticipants received 3 doses of talimogene laherparepvec administered by direct injection 3 weeks apart. At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until week 15 in a regimen of at least 3 weeks between doses.
Receives: Biological: Talimogene Laherparepvec

What is being measured

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

  1. Number of Participants With Adverse Events

    A serious adverse event is defined as any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important and significant medical event that, based upon appropriate medical judgment, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed above.

    Measured: From first dose of talimogene laherparepvec until 30 days after the last dose; the median duration of treatment was 44.0 days, 22.0 days, and 11.5 days in each group respectively.

  2. Number of Participants With Talimogene Laherparepvec Detected in Blood and Urine

    Samples of blood and urine collected before and up to 24 hours after dosing were tested for the presence of talimogene laherparepvec deoxyribonucleic acid (DNA) using a validated quantitative polymerase chain reaction (qPCR) assay.

    Measured: Treatment Day 1 predose and 2, 6, 12 and 24 hours postdose, and Week 3 and 6 at (predose and 2 hours postdose.

  3. Number of Participants Positive for Anti-herpes Simplex Virus-1 (HSV-1) Antibodies

    Anti-HSV-1 antibodies were detected using an enzyme-linked immunosorbent assay (ELISA).

    Measured: Week 0 (Day 1, predose) and Week 3

Secondary outcomes (3)

  1. Change From Baseline in Sum of Longest Diameters of Injected Tumors

    Spiral computed tomography (CT) scans were performed to assess tumors at screening and at Weeks 6, 12 and 18 after the initial dose.

    Measured: Baseline and Week 6, 12 and 18

  2. Number of Participants With Overall Objective Response

    Tumor response was assessed via CT scan by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 guidelines. Objective response is defined as a complete response (CR) or partial response (PR).

    CR: Disappearance of all target and non-target lesions, normalization of tumor marker level and no new lesions and with confirmation no less than 4 weeks after the criteria for CR is first met.

    PR: At least a 30% decrease in the sum of longest diameters of target lesions taking as reference the baseline sum of the longest diameters, absence of non-target lesion progression, and no new lesions. These criteria must be confirmed no less than 4 weeks after they are first met.

    Measured: Every 6 weeks until 12 weeks after the last dose; the median duration of treatment was 44.0 days, 22.0 days, and 11.5 days in each group respectively.

  3. Change From Baseline in Pain Intensity

    Pain was assessed by the participant using a validated Visual Analog Scale (VAS) pain assessment instrument. A single 10-cm line was used with the leftmost end (0 cm) representing "no pain" and the rightmost end (10 cm) representing "worst pain". The distance was measured from the leftmost part of the scale to the mark made by the participant indicating pain level.

    Measured: Baseline and Weeks 3 and 6

Timeline

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

  1. First posted22 Nov 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionJan 2008
  4. Study completionJan 2008

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00402025
Sponsor's protocol ID
005/04
Status last verified
Apr 2016
First submitted
17 Nov 2006
Last updated
15 Apr 2016

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Talimogene Laherparepvec in people with Pancreatic Cancer, run by BioVex Limited at 3 sites 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 23 inclusion and 17 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 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Yes. Results are posted in the registry (first posted 15 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Adverse Events (time frame: From first dose of talimogene laherparepvec until 30 days after the last dose; the median duration of treatment was 44.0 days, 22.0 days, and 11.5 days in each group respectively.). The study lists 3 primary outcomes in all. 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 NCT00402025.

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 15 Apr 2016.

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