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

NCT01909752 | Completed Phase 2

• 2 other identifiers: UbiVac DPV-001R44CA121612
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Lung cancer; DRibble Vaccine; Imiquimod; GM-CSF; HPV vaccine (Ceravix); Cyclophosphamide

Outcome Measures

Primary Outcomes (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.

  95 days

Secondary Outcomes (3)

• Safety

  43 weeks

• Progression free survival

  2 years

• Immune response and progression-free survival correlation.

  2 years

Study Arms (3)

DRibble Vaccine Alone

EXPERIMENTAL

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; Biological: DRibble vaccine; Biological: HPV vaccine

DRibble vaccine with imiquimod

EXPERIMENTAL

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; Biological: DRibble vaccine; Drug: Imiquimod; Biological: HPV vaccine

DRibble vaccine with GM-CSF

EXPERIMENTAL

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; Biological: DRibble vaccine; Drug: GM-CSF; Biological: HPV vaccine

Interventions

Cyclophosphamide DRUG

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

Also known as: Cytoxin

DRibble Vaccine Alone; DRibble vaccine with GM-CSF; DRibble vaccine with imiquimod

DRibble vaccine BIOLOGICAL

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

DRibble Vaccine Alone; DRibble vaccine with GM-CSF; DRibble vaccine with imiquimod

Imiquimod DRUG

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.

Also known as: Aldara

DRibble vaccine with imiquimod

GM-CSF DRUG

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.

Also known as: Leukine

DRibble vaccine with GM-CSF

HPV vaccine BIOLOGICAL

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.

Also known as: Ceravix

DRibble Vaccine Alone; DRibble vaccine with GM-CSF; DRibble vaccine with imiquimod

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UbiVac: lead
• National Cancer Institute (NCI): collaborator
• Providence Cancer Center, Earle A. Chiles Research Institute: collaborator
• Providence Health & Services: collaborator
• Mayo Clinic: collaborator
• Louisiana State University Health Sciences Center in New Orleans: collaborator

Study Sites (2)

LSU Stanley S. Scott Cancer Center

New Orleans, Louisiana, 70112, United States

Location

Providence Cancer Center

Portland, Oregon, 97213, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Cyclophosphamide; Imiquimod; Granulocyte-Macrophage Colony-Stimulating Factor; sargramostim; Papillomavirus Vaccines

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Bernard Fox, PhD

  UbiVac

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2013
• First Posted: July 26, 2013
• Study Start: July 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: April 1, 2017
• Last Updated: July 6, 2017

Record last verified: 2017-07

Locations

US (2)