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Neoplasms, LungPhase 1/2NCT02084823

Vaccine Therapy in Treating Lung Cancer Patients With Cancer Stem Cells

A Phase 1/2 study testing cancer stem cell vaccine in people with Neoplasms, Lung, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.

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

Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors into immunosuppressed mice, preventing an assessment on the immunologic interactions and effects of CSCs. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Neoplasms, Lung
What is being tested?
cancer stem cell vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteChina
Study dates
Mar 2014to Dec 2014
Phase
Phase 1/2
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 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically or cytologically confirmed adenocarcinoma of the lung.The site of the primary lesion should be confirmed radiologically, or surgically to be in the lung.
  • Patients must be deemed unresectable due to involvement of critical vasculature, adjacent organ invasion, presence of metastasis, or other medical condition making surgical resection unfavorable.
  • Patients must have a primary or metastatic lesion measurable in at least one dimension by RECIST criteria within 4 weeks prior to entry of study .
  • More than 4 weeks must have elapsed from the time of major surgery or completion of the last dose of chemotherapy, radiation therapy, investigational therapy and patients must adequately recover from these effects.
  • Life expectancy of >3 months. 6. Karnofsky performance status >70%. 7. The patient shows normal organ function according to the following parameters(as measured within six weeks prior to treatment allocation):
  • Hemoglobin: Within normal range according to institutional standards; Absolute leukocyte count: Within normal range according to institutional standards; Absolute lymphocyte count: Within normal range according to institutional standards; Platelet count: Within normal range according to institutional standards; Alanine aminotransferase: ≤ 2.5 x Upper Limit of Normal (ULN); Aspartate aminotransferase: ≤ 2.5 x ULN; Total bilirubin: ≤ 1.5 x ULN. In the case of known Gilbert's syndrome ≤ 2 x ULN; Serum creatinine: 1.5 x ULN; Calculated creatinine clearance: > 50 mL/min . 8. Age >18 years. 9. No history of autoimmune diseases. 10. Ability to understand the study protocol and a willingness to sign a written informed consent document.

Who cannot join

  • 1. Patients receiving anticoagulation therapy. 2. Patients who have received prior gemcitabine or radiation therapy to the lung bed 3. Patients receiving any other investigational agents. 4. Patients with known brain metastases will be excluded because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse effects.
  • 5. Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.
  • 6. Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV. 7. level 3 hypertension; 8. severe coronary disease; 9. myelosuppression; 10. respiratory disease; 11. brain metastasis; 12. chronic infections

Trial locations and contacts

1 site in 1 country.

China1 site

  • Biological treatment center in Fuda cancer hospital

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: Study of Cancer Stem Cell Vaccine That as a Specific Antigen in Metastatic Adenocarcinoma of the Lung

Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors into immunosuppressed mice, preventing an assessment on the immunologic interactions and effects of CSCs. In this study, the investigators examined the vaccination effects produced by CSC-enriched populations from histologically distinct murine tumors after their inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic and more effective as an antigen source than unselected tumor cells in inducing protective antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed antibodies and T cells were capable of selective targeting CSCs and conferring antitumor immunity.

Read the detailed description

To assess the feasibility of generating CSC-loaded DC vaccines for clinical use, the investigators will harvest peripheral blood and tumor specimen from patients with Lung Cancer. The investigators will purify T, B cells and generate DCs from the PBMCs of the Lung cancer patient.On the other hand, investigators will isolate ALDHhigh and ALDHlow tumor cells from the tumor specimen of the Lung cancer patient using a similar protocol as investigators reported .

Aim 1: To demonstrate, in vitro, the relative cellular anti-Lung cancer CSC immunity induced by Lung cancer CSC-DC primed cytotoxic T cells.

Aim 2: To determine, in vitro, specific binding and lysis of Lung cancer CSCs by antibodies produced by purified B cells from PBMCs stimulated with Lung cancer CSC-DC.

Conditions
Neoplasms, Lung
Being tested
cancer stem cell vaccine
Medical subject headings
Lung Neoplasms

What participants receive

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

  • cancer stem cell vaccineBiological

Study groups in NCT02084823
Study groupRoleWhat they receive
non-cancer stem cell vaccinePlacebo comparatorThe using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.
Receives: Biological: cancer stem cell vaccine
giving low dose vaccineExperimentalThe using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.
Receives: Biological: cancer stem cell vaccine
giving middle dose vaccineExperimentalThe using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.
Receives: Biological: cancer stem cell vaccine
giving high dose vaccineExperimentalThe using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.
Receives: Biological: cancer stem cell vaccine

What is being measured

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

  1. The primary study purpose to determine the safety of immunization with cancer stem cells vaccine by the number of participants with adverse events

    Measured: up to 3 months

Secondary outcomes (1)

  1. The secondary objectives are to evaluate vaccine immune responses to the immunizations by the data of body measurements

    Measured: 1 month

Timeline

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

  1. First posted12 Mar 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionOct 2014
  4. Study completionDec 2014

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02084823
Sponsor's protocol ID
CLL-001
Other IDs
201401
Status last verified
Mar 2014
First submitted
9 Mar 2014
Last updated
3 Jun 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Ning N, Pan Q, Zheng F, Teitz-Tennenbaum S, Egenti M, Yet J, Li M, Ginestier C, Wicha MS, Moyer JS, Prince ME, Xu Y, Zhang XL, Huang S, Chang AE, Li Q. Cancer stem cell vaccination confers significant antitumor immunity. Cancer Res. 2012 Apr 1;72(7):1853-64. doi: 10.1158/0008-5472.CAN-11-1400.

    PubMed 22473314

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing cancer stem cell vaccine in people with Neoplasms, Lung, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.

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 6 inclusion and 3 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 3 Jun 2015. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The primary study purpose to determine the safety of immunization with cancer stem cells vaccine by the number of participants with adverse events (time frame: up to 3 months). 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 NCT02084823, 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 3 Jun 2015.

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