Trial | NCT01909752  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    12
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.
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 Started
Jul 31
2013
Primary Completion
Nov 30
2016
Study Completion
Apr 30
2017
Last Update
Jul 06
2017

Drug Cyclophosphamide

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

  • Other names: 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 names: Aldara

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 names: 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 names: Ceravix

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.

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.

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.

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
No Results Posted