Trial Outcomes & Findings for Vaccine Therapy in Patients With Stages IIIB/IV Non-Small Cell Lung Cancer Who Have Finished First-Line Chemotherapy (NCT NCT00534209)

NCT ID: NCT00534209

Last Updated: 2017-10-16

Results Overview

This will include the number of patients experiencing toxicity over the course of treatment, characterized by type of toxicity and grade, and by the time of toxicity onset in relation to day of vaccination.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: Up to 13 weeks
• Results posted on: 2017-10-16

Participant Flow

Participant milestones

Measure	Arm I Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines. Given intradermally.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vaccine Therapy in Patients With Stages IIIB/IV Non-Small Cell Lung Cancer Who Have Finished First-Line Chemotherapy

Baseline characteristics by cohort

Measure	Arm I n=1 Participants Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines. Given intradermally.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 13 weeks

This will include the number of patients experiencing toxicity over the course of treatment, characterized by type of toxicity and grade, and by the time of toxicity onset in relation to day of vaccination.

Outcome measures

Measure	Arm I n=1 Participants Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines. Given intradermally.	Arm II: Placebo Patients receive a placebo vaccine intradermally once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines. Placebo: Given intradermally
Preliminary Safety Profile (Phase 1)	1 participants	—

PRIMARY outcome

Timeframe: Date of randomization to the earliest date of documented progression.

Population: This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: About 13 weeks

Population: This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.

Rate of immune response (CD8) in B-7 vaccinated participants reported for measurements taken immediately prior to vaccination (week 0) and throughout the two courses.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Week 1 of Study Therapy until Death or Withdrawal of Consent

Population: This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.

Relationship of CD8 response in B7-vaccinated patients to their progression-free survival. Summarized by the median and range of follow up time for patients grouped according to disease status (progression/no progression) and vital status (died/alive at last contact).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: About 13 weeks

Population: This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.

The rate of patients experiencing toxicity over the course of treatment will be characterized by type of toxicity and grade, and by the time of toxicity onset in relation to day of vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Week 1 of Study Therapy until Death or Withdrawal of Consent

Population: This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.

The percentage of patients experiencing a clinical response (complete response (CR), partial response (PR), stable disease (SD)) on second-line chemotherapy will be characterized for B7-vaccinated patients and controls.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Date of randomization to the recorded date of death

Population: This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.

The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that study participants are still alive.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 7 and Week 13

Population: This was an outcome measure for the Phase 2 portion of the study, which was never opened to accrual. No participants were enrolled in Phase 2 therefore no data were available.

The time course of patients' adaptive immune response to B7 vaccination as compared to control vaccine will be characterized by their CD8, CD4, and NK response (measured by ELI-spots for interferon-gamma (IFN-γ), interleukin 4 (IL-4), and granzyme B secretion) measured prior to vaccination (i.e. at baseline) and over two courses of vaccination (measurements at week 7 and 13).

Outcome measures

Outcome data not reported

Adverse Events

Arm I

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm I n=1 participants at risk Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines. Given intradermally.
Musculoskeletal and connective tissue disorders Grade 3 Edema limbs	100.0% 1/1 • Number of events 1
Blood and lymphatic system disorders Grade 3 Vascular access complication	100.0% 1/1 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Luis Raez MD

UM/Sylvester Comprehensive Cancer Center

Phone: 305-243-4909

Email: lraez@med.miami.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place