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

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cyclophosphamide
DRibble vaccine
Imiquimod
GM-CSF
HPV vaccine
Sponsored by
UbiVac
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Lung cancer, DRibble Vaccine, Imiquimod, GM-CSF, HPV vaccine (Ceravix), Cyclophosphamide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • LSU Stanley S. Scott Cancer Center
  • Providence Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

DRibble Vaccine Alone

DRibble vaccine with imiquimod

DRibble vaccine with GM-CSF

Arm Description

Cyclophosphamide (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.

Cyclophosphamide (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.

Cyclophosphamide (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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
July 24, 2013
Last Updated
July 3, 2017
Sponsor
UbiVac
Collaborators
National Cancer Institute (NCI), Providence Cancer Center, Earle A. Chiles Research Institute, Providence Health & Services, Mayo Clinic, Louisiana State University Health Sciences Center in New Orleans
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1. Study Identification

Unique Protocol Identification Number
NCT01909752
Brief Title
Combination Vaccine Immunotherapy (DRibbles) for Patients With Definitively-Treated Stage III Non-small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UbiVac
Collaborators
National Cancer Institute (NCI), Providence Cancer Center, Earle A. Chiles Research Institute, Providence Health & Services, Mayo Clinic, Louisiana State University Health Sciences Center in New Orleans

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 response will include common antigens shared by both the vaccine and the patient's tumor.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
Keywords
Lung cancer, DRibble Vaccine, Imiquimod, GM-CSF, HPV vaccine (Ceravix), Cyclophosphamide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DRibble Vaccine Alone
Arm Type
Experimental
Arm Description
Cyclophosphamide (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.
Arm Title
DRibble vaccine with imiquimod
Arm Type
Experimental
Arm Description
Cyclophosphamide (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.
Arm Title
DRibble vaccine with GM-CSF
Arm Type
Experimental
Arm Description
Cyclophosphamide (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.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Cytoxin
Intervention Description
Cyclophosphamide (300 mg/m2) will be administered as a single dose three days prior to beginning vaccine therapy.
Intervention Type
Biological
Intervention Name(s)
DRibble vaccine
Intervention Description
DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19, 25, 31, 37, and 43.
Intervention Type
Drug
Intervention Name(s)
Imiquimod
Other Intervention Name(s)
Aldara
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
GM-CSF
Other Intervention Name(s)
Leukine
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
HPV vaccine
Other Intervention Name(s)
Ceravix
Intervention Description
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.
Primary Outcome Measure Information:
Title
Identify the regimen that produces the strongest antibody response
Description
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.
Time Frame
95 days
Secondary Outcome Measure Information:
Title
Safety
Description
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.
Time Frame
43 weeks
Title
Progression free survival
Description
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.
Time Frame
2 years
Title
Immune response and progression-free survival correlation.
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Fox, PhD
Organizational Affiliation
UbiVac
Official's Role
Study Director
Facility Information:
Facility Name
LSU Stanley S. Scott Cancer Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Providence Cancer Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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