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

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ClinicalTrials.gov Identifier: NCT01909752
Recruitment Status : Completed
First Posted : July 26, 2013
Last Update Posted : July 6, 2017
Sponsor:
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
Information provided by (Responsible Party):
UbiVac

Study Description
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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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Cyclophosphamide Biological: DRibble vaccine Drug: Imiquimod Drug: GM-CSF Biological: HPV vaccine Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2013
Actual Primary Completion Date : November 2016
Actual Study Completion Date : April 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: DRibble Vaccine Alone
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.
 Drug: Cyclophosphamide
Cyclophosphamide (300 mg/m2) will be administered as a single dose three days prior to beginning vaccine therapy.
Other Name: Cytoxin

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

Biological: HPV vaccine
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.
Other Name: Ceravix
Experimental: DRibble vaccine with imiquimod
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.
 Drug: Cyclophosphamide
Cyclophosphamide (300 mg/m2) will be administered as a single dose three days prior to beginning vaccine therapy.
Other Name: Cytoxin

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

Drug: Imiquimod
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.
Other Name: Aldara

Biological: HPV vaccine
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.
Other Name: Ceravix
Experimental: DRibble vaccine with GM-CSF
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.
 Drug: Cyclophosphamide
Cyclophosphamide (300 mg/m2) will be administered as a single dose three days prior to beginning vaccine therapy.
Other Name: Cytoxin

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

Drug: GM-CSF
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.
Other Name: Leukine

Biological: HPV vaccine
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.
Other Name: Ceravix


Outcome Measures
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Primary Outcome Measures :
  1. Identify the regimen that produces the strongest antibody response [ Time Frame: 95 days ]
    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 :
  1. Safety [ Time Frame: 43 weeks ]
    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.

  2. Progression free survival [ Time Frame: 2 years ]
    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.

  3. Immune response and progression-free survival correlation. [ Time Frame: 2 years ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01909752


Locations
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United States, Louisiana
LSU Stanley S. Scott Cancer Center
New Orleans, Louisiana, United States, 70112
United States, Oregon
Providence Cancer Center
Portland, Oregon, United States, 97213
Sponsors and Collaborators
UbiVac
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
Investigators
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Study Director: Bernard Fox, PhD UbiVac
More Information
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Responsible Party: UbiVac
ClinicalTrials.gov Identifier: NCT01909752    
Other Study ID Numbers: UbiVac DPV-001
R44CA121612 ( U.S. NIH Grant/Contract )
First Posted: July 26, 2013    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Keywords provided by UbiVac:
Lung cancer
DRibble Vaccine
Imiquimod
 GM-CSF
HPV vaccine (Ceravix)
Cyclophosphamide
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cyclophosphamide
Imiquimod
 Vaccines
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Adjuvants, Immunologic
Interferon Inducers