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Carcinoma, Non-Small-Cell LungPhase 2NCT01909752

Combination Vaccine Immunotherapy (DRibbles) for Patients With Definitively-Treated Stage III Non-small Cell Lung Cancer

A Phase 2 study testing Cyclophosphamide, DRibble vaccine and Imiquimod in people with Carcinoma, Non-Small-Cell Lung, run by UbiVac at 2 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

This study will test an investigational vaccine, called DRibbles, for the treatment of non-small cell lung cancer (NSCLC). We hypothesize that vaccination with the DRibble vaccine will cause an immune responses against proteins contained in the DRibble vaccine and the protein antigens targeted by this strong immune… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Cyclophosphamide, DRibble vaccine and Imiquimod
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesUnited States
Study dates
Jul 2013to Apr 2017
Phase
Phase 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Stage IIIA or IIIB histologically proven non-small cell lung cancer
  • Completion of definitive therapy
  • Enrollment from 28 days to 12 weeks from completion of definitive therapy
  • Toxicities from definitive therapy resolved to less than grade 1
  • ECOG performance status 0-1
  • Negative pregnancy test in women of childbearing potential
Show all 12Show fewer
  • Agree to avoid pregnancy or fathering a child while on study treatment
  • Ability to give informed consent and comply with protocol
  • Anticipated survival minimum of 6 months
  • Prior therapy with investigational agents must be completed at least 3 weeks prior to study enrollment
  • Normal organ and marrow function as defined by specific lab tests
  • Archived tumor tissue available

Who cannot join

  • Active autoimmune disease except for vitilogo or hypothyroidism
  • Active other malignancy
  • Known HIV+ and/or Hepatitis B or C positive
  • Medical or psychiatric conditions that would preclude safe participation
  • Ongoing chemotherapy

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • LSU Stanley S. Scott Cancer Center

    New Orleans, Louisiana, 70112

  • Providence Cancer Center

    Portland, Oregon, 97213

Other trials in United States

About this study

Official title: Randomized Phase II Trial of Cyclophosphamide With Allogeneic Non-Small Cell Lung Cancer (NSCLC) DRibble Vaccine Alone or With Granulocyte-Macrophage Colony-Stimulating Factor or Imiquimod for Adjuvant Treatment of Definitively-Treated Stage IIIA or IIIB NSCLC

This study will test an investigational vaccine, called DRibbles, for the treatment of non-small cell lung cancer (NSCLC). We hypothesize that vaccination with the DRibble vaccine will cause an immune responses against proteins contained in the DRibble vaccine and the protein antigens targeted by this strong immune response will include common antigens shared by both the vaccine and the patient's tumor.

Read the detailed description

This is an open-label, randomized study in which the first 33 patients will be assigned to receive the either:

  • DRibbles vaccine and HPV vaccine
  • DRibbles vaccine, HPV vaccine, and imiquimod
  • DRibbles vaccine, HPV vaccine, and GM-CSF After 11 patients have been assigned to each group, the study arm with the greatest number of vaccine-induced strong antibody responses will then continue with enrollment of 15 further patients. The primary objective is to determine the best strategy to induce strong (>15 fold) tumor-specific or tumor-associated antibody responses in patients with stage III A and B NSCLC. The goal is to select one regimen to advance to additional clinical trials.
Being tested
Cyclophosphamide, DRibble vaccine, Imiquimod, GM-CSF, HPV vaccine
Keywords
Lung cancer, DRibble Vaccine, Imiquimod, GM-CSF, HPV vaccine (Ceravix), Cyclophosphamide
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

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

  • CyclophosphamideDrug

    Also called Cytoxin

    Cyclophosphamide (300 mg/m2) will be administered as a single dose three days prior to beginning vaccine therapy.

  • DRibble vaccineBiological

    DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19, 25, 31, 37, and 43.

  • ImiquimodDrug

    Also called Aldara

    Imiquimod cream (5%, 250 mg containing 12.5 mg imiquimod - one packet/day) will be self applied once per day starting with the second vaccine (week 4). Immediately following vaccination and for four days following each vaccine cycle (total 5 days) imiquimod will be applied to a 4 x 5-cm outlined area of healthy extremity skin that includes the vaccine site.

  • GM-CSFDrug

    Also called Leukine

    GM-CSF will be administered at 50 mcg/day starting with the second vaccine (week 4) and continuing with each subsequent vaccine. A volume of 0.2 cc will be delivered by the CADD-MSTM 3 Ambulatory infusion pump at a rate of 0.008 cc/hr. The pump will be refilled after three days for a total of six days of infusion.

  • HPV vaccineBiological

    Also called Ceravix

    Immunization with HPV vaccine will consist of two 0.5-mL intramuscular injection at the time of the first and third vaccinations. The preferred site of administration is the deltoid region of the upper arm.

Study groups in NCT01909752
Study groupRoleWhat they receive
DRibble Vaccine AloneExperimentalCyclophosphamide (300 mg/m2) will be administered as a single dose three days prior to beginning vaccine therapy. DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19, 25, 31, 37, and 43. Immunization with HPV vaccine intramuscular injection at the time of the first and third vaccinations.
Receives: Drug: Cyclophosphamide; Biological: DRibble vaccine; Biological: HPV vaccine
DRibble vaccine with imiquimodExperimentalCyclophosphamide (300 mg/m2) will be administered as a single dose three days prior to beginning vaccine therapy. DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19, 25, 31, 37, and 43. Imiquimod cream (5%, 250 mg containing 12.5 mg imiquimod - one packet/day) will be self applied once per day starting with the second vaccine (week 4) and for four days following each vaccine cycle. Immunization with HPV vaccine intramuscular injection at the time of the first and third vaccinations.
Receives: Drug: Cyclophosphamide; Biological: DRibble vaccine; Drug: Imiquimod; Biological: HPV vaccine
DRibble vaccine with GM-CSFExperimentalCyclophosphamide (300 mg/m2) will be administered as a single dose three days prior to beginning vaccine therapy. DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19, 25, 31, 37, and 43. GM-CSF will be administered at 50 mcg/day starting with the second vaccine (week 4) and continuing with each subsequent vaccine. Immunization with HPV vaccine intramuscular injection at the time of the first and third vaccinations.
Receives: Drug: Cyclophosphamide; Biological: DRibble vaccine; Drug: GM-CSF; Biological: HPV vaccine

What is being measured

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

  1. Identify the regimen that produces the strongest antibody response

    The best regimen will be defined as the one that generates the greatest increase in the number of strong antibody responses as defined by a greater than 15-fold increase in antibody, as measured using the Immune Response Biomarker Profiling Array (Invitrogen) on the day 95 serum sample.

    Measured: 95 days

Secondary outcomes (3)

  1. Safety

    To evaluate the overall safety of allogeneic NSCLC DRibble vaccine alone or in combination with either imiquimod or GM-CSF, as adjuvant treatment for definitively-treated patients with Stage IIIA or B NSCLC. During the treatment period, patients will be seen in clinic 13 times over a 22-week period; performance status and side-effects will be evaluated at each visit.

    Measured: 43 weeks

  2. Progression free survival

    Evaluate progression-free survival. Tumor measurements by CT scan will be obtained at week 16 and subsequently at the discretion of the treating investigator. After the treatment period, patients will be seen every 3 months for 2 years, or until progressive disease.

    Measured: 2 years

  3. Immune response and progression-free survival correlation.

    Evaluate whether any immune response data correlate with progression-free survival. Immune response data will be collected 12 times over the first 43 weeks and then every 3 months until two years or progressive disease. This data will be correlated with progression-free survival.

    Measured: 2 years

Timeline

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

  1. First posted26 Jul 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionNov 2016
  4. Study completionApr 2017

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01909752
Sponsor's protocol ID
UbiVac DPV-001
Other IDs
R44CA121612
Status last verified
Jul 2017
First submitted
24 Jul 2013
Last updated
6 Jul 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cyclophosphamide, DRibble vaccine and Imiquimod in people with Carcinoma, Non-Small-Cell Lung, run by UbiVac 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 12 inclusion and 5 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 6 Jul 2017. 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 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?

Identify the regimen that produces the strongest antibody response (time frame: 95 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 NCT01909752.

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 6 Jul 2017.

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