Study of the Telomerase Vaccine GV1001 to Treat Patients With Inoperable Stage III Non-small Cell Lung Cancer

NCT01579188 | Unknown Phase 3 DMC

• 1 other identifier: KG 1/2012
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate survival in inoperable stage III Non-small Cell Lung Cancer patients following chemo-radiotherapy followed by GV1001 vaccination plus best supportive care.

Conditions

Inoperable Stage III Non-small Cell Lung Cancer

Keywords

NSCLC

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  To evaluate OS in inoperable stage III NSCLC patients following chemoradiotherapy administered with a curative intent followed by GV1001 vaccination plus best supportive care (BSC)

  2 years

Secondary Outcomes (2)

• Safety and tolerability of GV1001

  2 years

• Immunological response

  2 years

Study Arms (2)

GV1001

EXPERIMENTAL

The adjuvant GM-CSF is administered first as an intradermal injection followed in 10-15 minutes by the GV1001 peptide injected into the same site.

Drug: GV1001

Placebo

PLACEBO COMPARATOR

Placebo

Drug: normal saline

Interventions

GV1001 DRUG

Intradermal injection 0.84 mg ± 0.084 mg 3 times in Week 1 (Monday, Wednesday, and Friday) and once (Mondays) in Weeks 2, 3, 4, 6, 8, and 10, followed by boost injections given on Weeks 14, 18, 22, 26, and thereafter at 12 week intervals up to Week 98

GV1001

normal saline DRUG

two injections of normal saline injected in the same manner as the experimental drug, GV1001

Placebo

Eligibility Criteria

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

You may qualify if:

• Patients may be entered in the study only if they meet all of the following criteria:
• Male or female patient ≥ 18 years of age;
• Histologically or cytologically confirmed inoperable NSCLC stage III disease;
• Patient must have received chemo-radiotherapy with a curative intent with the following definition: any planned regimen consisting of a platinum-doublet containing chemotherapy given concomitantly with up to 66Gy of radiation therapy. Gemcitabine cannot be part of the platinum-based doublet;
• Life expectancy of ≥ 3 months;
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2;
• Patients must have adequate bone marrow function as evidenced by absolute neutrophil count (ANC) ≥ 1.0 X 109/L, hemoglobin ≥ 9.0 g/dL (a hemoglobin \< 9.0 g/dL at Screening is acceptable if it is corrected to ≥ 9 g/dL by growth factor or transfusion prior to first dose), and platelet count ≥ 75 X 109/L (platelet counts below 75 X 109/L may be re-screened within 4 weeks of chemoradiotherapy);
• Patients must have adequate liver function as evidenced by bilirubin ≤ 1.5 times the upper limit of the normal range (ULN), and alkaline phosphatase, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 X ULN;
• Female patients of childbearing potential (i.e. ovulating, premenopausal, not surgically sterile), and all male patients are required to be sexually abstinent or use a medically accepted contraceptive regimen during their participation in the study and for 90 days after study completion. Medically accepted contraceptive methods are defined as those with 90% or greater efficacy;
• Females of childbearing potential must have a negative pregnancy test;
• Females may not be breastfeeding; and
• Ability to understand and willingness to sign a written informed consent.

You may not qualify if:

• Patients will not be entered in the study for any of the following reasons:
• Prior treatment with gemcitabine, prior targeted therapy (including erlotinib \[Tarceva®\], or gefitinib \[Iressa®\]), or immunological therapy including tumor vaccine therapy intended for the management of NSCLC;
• A minimum of 1 week and a maximum of 4 weeks must have elapsed from the chemo-radiotherapy and patient must have recovered from all treatment-related toxicities to Grade ≤ 1 (CTCAE version 4.03), except for alopecia;
• History of other malignancies except: (1) adequately treated basal or squamous cell carcinoma of the skin; (2) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (3) other curatively treated solid tumor with no evidence of disease for ≥ 3 years;
• Received treatment in another clinical study within the 30 days prior to commencing study treatment or patients who have not recovered from side effects of an investigational drug to Grade ≤ 1 (CTCAE version 4.03), except for alopecia;
• Are currently receiving any other cancer treatment, even if given with palliative intent;
• Uncontrolled pleural effusions, ascites, or other third space fluid collections;
• Uncontrolled diabetes mellitus Type 1 or 2;
• Significant cardiovascular impairment (history of congestive heart failure \> New York Heart Association (NYHA) Grade II, unstable angina or myocardial infarction within the past 6 months, or serious cardiac arrhythmia);
• Patients with organ allografts requiring immunosuppression;
• Need for systemic steroid treatment unless chronic daily dose used is ≤ 5mg prednisone or equivalent. Note: Higher dose systemic steroid treatment (≥ 60mg/day of prednisone or equivalent) administered for ≤ 2 weeks in any single episode is permissible if administered for an acute inflammatory condition;
• Known severe adverse reactions to vaccines;
• Known severe adverse events or allergy to GM-CSF;
• Known positive human immunodeficiency virus (HIV), known hepatitis B surface antigen, or hepatitis C positive; and
• Have any medical condition that would interfere with the conduct of the study.

Sponsors & Collaborators

• Kael-GemVax Co., Ltd.: lead
• Quintiles, Inc.: collaborator

MeSH Terms

Interventions

GV1001 peptide; Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Sinae Jeong

  Kael-GemVax Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2012
• First Posted: April 17, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: April 19, 2012

Record last verified: 2012-04