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Non Small Cell Lung Cancer (NSCLC)Phase 1NCT00793208

Immunization of Patients With Non Small Cell Lung Cancer (NSCLC)

A Phase 1 study testing semi-allogeneic human fibroblasts (MRC-5) transfected with DNA in people with Non Small Cell Lung Cancer (NSCLC), run by Theresa Whiteside, PhD at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The study of the vaccine will proceed in two stages after the method of Simon (102). In the first stage, 15 patients will be accrued and treated. If two or fewer objective immunologic responses occur, the study will be terminated. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer (NSCLC)
What is being tested?
semi-allogeneic human fibroblasts (MRC-5) transfected with DNA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
2 sitesUnited States
Study dates
Dec 2008to Nov 2015
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

  • Written informed consent conforming to the institutional guidelines obtained from the patient.
  • A diagnosis of non-small cell lung cancer (NSCLC), subjects will undergo or have had surgical resection.
  • Age 18 or above.
  • Karnofsky performance status > 70
  • Adequate hematologic function:
  • Absolute neutrophil count > 1,000/mm3
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  • Absolute lymphocyte count > 1,000/mm3
  • Hemoglobin > 9 g/dL
  • Platelets > 100,000/mm3
  • Liver function tests:
  • Bilirubin (total) < 1.7 mg/dL
  • Alkaline phosphatase < 252 u/L
  • SGOT < 108 u/L
  • Kidney profile:
  • Serum electrolytes
  • Sodium 136-146 mEq/L
  • Potassium 3.5-5.0 mEq/L
  • Bicarbonate 21-31 mEq/L
  • Chloride 98-107 mmol/L
  • Serum creatinine < 3 x ULN
  • BUN 8-26 mg/dL
  • At least a 12 week interval should have elapsed between vaccination and any prior radiation therapy, chemotherapy or any other treatment. Patients should have recovered from surgery and adjuvant treatment.

Who cannot join

  • Subjects will be EXCLUDED from participation in the study if any of the following apply:
  • One or more of the Inclusion Criteria are not met.
  • A significant history or current evidence of cardiac disease including, but not limited to: congestive heart failure, coronary artery disease, angina pectoris, uncontrolled hypertension, serious arrythmias or myocardial infarction within the previous six months.
  • Evidence of active infection requiring antibiotic therapy.
  • Active intracranial metastases. Patients with previously resected intracranial disease and/or previously irradiated intracranial metastases that have been stable for four weeks are eligible.
  • Pregnant or lactating women. Pregnant women are excluded from this study. Women of childbearing potential must have a negative pregnancy test. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated on study.
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  • Patients requiring systemic corticosteroids (unless patient has had NO STEROIDS IN THE PAST 4 WEEKS).
  • Autoimmune disease including, but not limited to, rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, or ankylosing spondylitis
  • Patient must not have post-obstructive pneumonia or other serious infection at the time of registration or other serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
  • Subject is not a candidate for complete resection of the carcinoma via pneumonectomy, lobectomy, bilobectomy, extended wedge resection or anatomic segmentectomy with or without sleeve resection as noted in the surgical plan..
  • Prior resection of lung cancer is allowed, if at least five years have elapsed between previous resection and registration.
  • No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient has been disease-free for at least 5 years prior to registration.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Pittsburgh Cancer Institute - Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: Active Immunization of Patients With Non Small Cell Lung Cancer (NSCLC) Using Fibroblasts Transfected With DNA From Autologous Tumor (Phase IB Study)

The study of the vaccine will proceed in two stages after the method of Simon (102). In the first stage, 15 patients will be accrued and treated. If two or fewer objective immunologic responses occur, the study will be terminated. If 3 or more responses are observed, the study will proceed to the second stage, accruing an additional 22 patients. If the second stage is complete and a total of 9 or more immunologic responses are observed among the 37 patients treated, the treatment response rate for the vaccine will be considered high enough to warrant further study. Conversely, if the evaluation of the vaccine concludes at the first stage, or if 8 or fewer total immunologic responses occur after completing the second stage, the vaccine will not be considered for further study.

Read the detailed description

This is an uncontrolled, non-randomized trial to evaluate safety, immunogenicity and feasibility of a new vaccine, consisting of semi-allogeneic fibroblasts transfected with autologous tumor-derived DNA. Briefly, the plan is to use a two-stage trial design and to initially enroll 15 patients with non small cell lung cancer (NSCLC) over a period of 2 years. The patients will undergo surgery and a portion of the primary tumor specimen not necessary for the pathologic diagnosis will be obtained to serve as a source of tumor DNA. Each DNA-based vaccine will contain 1 x 10e7 DNA-transfected human allogeneic fibroblasts. The vaccine will be lethally irradiated before it is used for immunization. It will be administered intradermally in the Outpatient Clinic. Patients delayed-type hypersensitivity (DTH) responses will be tested but will not be an eligibility criterion. Immunologic response to the vaccine will be evaluated. If there is no evidence of toxicity, and >3 of the 15 initial patients show immunologic response, the second stage of the study will be opened for accrual of 22 patients. All patients will be monitored by IFN-g secretion in ELISPOT assays prior to and after vaccination for the frequency of T-cells responsive to autologous tumor (if available) and/or to the vaccine. The patients will also be evaluated before and after vaccination for the capability of their T cells to respond to activating signals delivered via the T cell receptor (TcR).

Being tested
semi-allogeneic human fibroblasts (MRC-5) transfected with DNA
Keywords
Lung cancer, non small cell, vaccine, carcinoma, immunization, autologous Tumor, vaccination
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Carcinoma

What participants receive

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

  • semi-allogeneic human fibroblasts (MRC-5) transfected with DNABiological

    Each vaccine consists of 1 x 10e7 DNA-transfected irradiated fibroblasts. A total of 4 weekly immunizations will be delivered to each patient. Each vaccine will be administered i.d. using a 1 mL syringe and a 25 gauge needle.

    Subjects will have immunizations administered at 4 different sites for each vaccination as follows:

    Site #1: Right arm Site #2: Left arm Site #3: Right thigh Site #4: Left thigh Approximately equal numbers of transfected fibroblasts will be administered at each site.

Study groups in NCT00793208
Study groupRoleWhat they receive
VaccineExperimentalvaccine composed of lethally irradiated semi-allogeneic human fibroblasts transfected with genomic tumor DNA from the patient's own tumor
Receives: Biological: semi-allogeneic human fibroblasts (MRC-5) transfected with DNA

What is being measured

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

  1. Safety and feasibility; patients will be observed for treatment-related toxicity during and after each immunization,and for 1 h after immunization in the event that an immediate-type hypersensitivity reaction occurs.

    Measured: 2.5 years

Secondary outcomes (1)

  1. To evaluate the ability of the DNA-based vaccine to induce immune responses to the autologous tumor (if available) and/or the vaccine.

    Measured: 14

Timeline

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

  1. First posted19 Nov 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionSep 2010
  4. Study completionNov 2015

Why it stopped: study closed due to low enrollment

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
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00793208
Sponsor's protocol ID
08-004
Status last verified
Apr 2019
First submitted
13 Nov 2008
Last updated
12 Apr 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing semi-allogeneic human fibroblasts (MRC-5) transfected with DNA in people with Non Small Cell Lung Cancer (NSCLC), run by Theresa Whiteside, PhD at 2 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 22 inclusion and 13 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: stopped early, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

The study was stopped early (reason given: study closed due to low enrollment). Results are not available in the source record.

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 and feasibility; patients will be observed for treatment-related toxicity during and after each immunization,and for 1 h after immunization in the event that an immediate-type hypersensitivity reaction occurs. (time frame: 2.5 years). 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 NCT00793208.

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 2019.

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