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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by UbiVac
Sponsor:
Collaborators:
Providence Cancer Center, Earle A. Chiles Research Institute
Providence Health & Services
Mayo Clinic
Information provided by (Responsible Party):
UbiVac
ClinicalTrials.gov Identifier:
NCT01909752
First received: July 24, 2013
Last updated: NA
Last verified: July 2013
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by UbiVac:

Primary Outcome Measures:
  • Identify the regimen that produces the strongest antibody response [ Time Frame: 95 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 43 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 48
Study Start Date: July 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01909752

Contacts
Contact: Brenda Fisher, RN (503) 215-2613 Brenda.Fisher@providence.org
Contact: Julie Cramer, MA (503) 215-9948 Julie.Cramer@providence.org

Locations
United States, Oregon
Providence Cancer Center Recruiting
Portland, Oregon, United States, 97213
Principal Investigator: Rachel Sanborn, MD         
Sub-Investigator: Alison Conlin, MD         
Sub-Investigator: Todd Crocenzi, MD         
Sub-Investigator: Brendan Curti, MD         
Sub-Investigator: John Godwin, MD         
Sub-Investigator: Keith Lanier, MD         
Sub-Investigator: Rom Leidner, MD         
Sub-Investigator: Walter Urba, MD, PhD         
Sponsors and Collaborators
UbiVac
Providence Cancer Center, Earle A. Chiles Research Institute
Providence Health & Services
Mayo Clinic
Investigators
Study Director: Bernard Fox, PhD UbiVac
  More Information

No publications provided

Responsible Party: UbiVac
ClinicalTrials.gov Identifier: NCT01909752     History of Changes
Other Study ID Numbers: UbiVac DPV-001, R44CA121612
Study First Received: July 24, 2013
Last Updated: July 24, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by UbiVac:
Lung cancer
DRibble Vaccine
Imiquimod
GM-CSF
HPV vaccine (Ceravix)
Cyclophosphamide

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Cyclophosphamide
Imiquimod
Adjuvants, Immunologic
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Interferon Inducers
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014