| CTRI Number |
CTRI/2010/091/000486 [Registered on: 20/05/2010] |
| Last Modified On: |
12/04/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
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A clinical trial to study the effects of Lucanix (Test Drug) in patients suffering from advanced non small cell Lung Cancer who have previously responded to or have a stable disease following treatment with platinum based combination chemotherapy. |
Scientific Title of Study
Modification(s)
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Phase III Study of Lucanix? (Belagenpumatucel-L) in Advanced Non-small Cell Lung Cancer: An International Multicenter, Randomized, Double-blinded, Placebo-controlled Study of Lucanix? Maintenance Therapy for Stages III/IV NSCLC Subjects Who Have Responded to or Have Stable Disease Following One Regimen of Front-line, Platinum-based Combination Chemotherapy |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NCT00676507 |
ClinicalTrials.gov |
| Nr001-03 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
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| Name |
Sanjay Kabra |
| Designation |
Director – Clinical Research |
| Affiliation |
Pharmanet/i3 |
| Address |
Unit 1101, Level 11, Millenia Tower B 1 and 2 Murphy Road, Bangalore, KARNATAKA 560 008, India
Bangalore
KARNATAKA
560 008
India |
| Phone |
912240957478 |
| Fax |
912240957499 |
| Email |
skabra@pharmanet-i3.com |
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Details of Contact Person
Public Query
Modification(s)
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| Name |
Syed Mohammad Abbas |
| Designation |
|
| Affiliation |
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| Address |
I3 Research, A Division of United Health Group Informations Services Pvt Ltd,
apexOne Business Suites, 7th Floor, Tower B, Millenium Plaza, Sushant Lok
Gurgaon
HARYANA
122002
India |
| Phone |
01244619918 |
| Fax |
01244619964 |
| Email |
Syed.Abbas@i3research.com |
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Source of Monetary or Material Support
Modification(s)
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| NovaRx Corp. 6828 Nancy Ridge Dr. Suite 100 San Diego, CA 92121 USA |
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Primary Sponsor
Modification(s)
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| Name |
NovaRx Corporation |
| Address |
6828 Nancy Ridge Dr. Suite 100 San Diego, CA 92121 USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
Modification(s)
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Countries of Recruitment
Modification(s)
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India
Canada
Hungary
Netherlands
Poland
Serbia
United Kingdom
United States of America |
Sites of Study
Modification(s)
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| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Srinivas Chakravarthy Gummaraju |
Apollo Hospitals |
,-500033
Hyderabad
ANDHRA PRADESH |
91 9989299091
hydaherf@gmail.com |
| Dr Harsha Panchal |
Gujarat Cancer Hospital and Research Institute, |
,-380016
Ahmadabad
GUJARAT |
91 9825940769
drharshapanchal@hotmail.com |
| Dr Minish Jain |
Noble Hospital |
,-411013
Pune
MAHARASHTRA |
91 9823133390
minishjain009@gmail.com |
| Dr. Sivanandan C D |
Regional Cancer Center |
,-695011
|
91 9447882149
sivanandancd@hotmail.com |
| Dr Anish Maru |
SEAROC Hospital |
,-302013
Jaipur
RAJASTHAN |
91 9829060128
anishmaru@yahoo.com |
| Dr Vanita Noronha |
Tata Memorial Hospital |
,-400012
Mumbai
MAHARASHTRA |
vanitanoronha@yahoo.com |
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Details of Ethics Committee
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| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee, Apollo Health City, Jubliee Hills, Hyderabad, 500 033, India, Ph 040 23556573, Fax 040 23543270, ecah.hyd@gmail.com |
Approved |
| Gujarat Cancer Society & Gujarat Cancer & Research Institute Ethics Committee, Civil Hospital, Campus Asarwa, Ahmedabad ? 380016, India. Ph 079 22681451, Fax 079 22685940. |
Approved |
| Human Ethics Committee, Tata Memorial Hospital, IRB Office, Dr. E Borges Marg, Parel, Mumbai 400012, India, Ph 022 2417 7262, Fax 022 2414 6937. |
Approved |
| Institute Review Board & Human Ethics Committee, Regional Cancer Centre, Thiruvananthapuram , Kerala, India, 695011. |
Approved |
| Noble Hospital ? Institutional Ethics Committee, Noble Hospital, 153 Magarpatta City Road, Pune 411013, Tel 020 6628 5000, Fax 020 6628 5199 |
Submittted/Under Review |
| SEAROC Ethics Committee, SEAROC Center, S K Soni Hospital, Sec 5, Vidhyadhar Nagar, Sikar Road, Jaipur 302004, Ph 0141 2232409, Fax 0141 2233337. |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Patients |
Non-Small Cell Lung Cancer, |
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Intervention / Comparator Agent
Modification(s)
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| Type |
Name |
Details |
| Intervention |
Biological: Lucanix |
Treatment Arm: This course of therapy is Best Support Care (BSC) plus monthly intradermal (ID) injections of Lucanix? (belagenpumatucel-L) consisting of 25,000,000 cells in a volume of 0.40 mL. |
| Comparator Agent |
Placebo Comparator |
This course of therapy is Best Support Care (BSC) plus a placebo injection that consists of 0.15% Intralipid® in solution composed of the cryopreservation formulation minus the gene modified cells and dimethyl sulfoxide (DMSO) in a volume of 0.40 mL |
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Inclusion Criteria
Modification(s)
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| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
o Subjects with histologically or cytologically confirmed NSCLC who meet one of the following staging requirements:
Stage IIIA (T3N2 only) or
Stage IIIB or
Stage IV.
o Subjects must have stable disease (SD) or better following a prior single, frontline, platinum-based chemotherapy regimen (additional prior adjuvant chemotherapy is permitted) consisting of up to six (6) treatment cycles with or without concomitant radiation therapy.
o Not less than four weeks nor more than four months must have elapsed since the completion of the last chemotherapy cycle and registration into the study.
o Subjects treated for brain metastasis(es) are eligible if they have been stable for ≥ 2 months. Signed informed consent.
o Not less than 18 years and not more than 75 years old.
o Estimated life expectancy of at least 12 weeks.
o Performance status (ECOG) ≤ 2.
o Absolute neutrophil count ≥ 1,500/mm3.
o Hemoglobin ≥ 9 g/dL.
o Platelet count ≥ 100,000/mm3.
o Albumin levels ≥ 2.5 g/dL.
o Bilirubin ≤ 1.5 times the upper limit of normal (ULN).
o Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤ 1.5 × ULN.
o Creatinine ≤ 1.5 × ULN.
o Alkaline phosphatase ≤ 5 × ULN
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| ExclusionCriteria |
| Details |
o Concurrent systemic steroids > 2 mg /day prednisone (or prednisone-equivalent of prednisolone or dexamethasone).
o Prior splenectomy.
o Any surgery involving general anesthesia < 4 weeks prior to study registration.
o Chemotherapy more than 4 months or less than 4 weeks prior to study registration.
o Steroid therapy (excluding ≤ 2 mg/day prednisone or prednisone-equivalent of prednisolone or dexamethasone), radiation therapy, other investigational products or immunotherapy less than 4 weeks prior to study registration.
o Subjects with documented active brain metastasis(es) at the time of study entry are ineligible. However, subjects treated for brain metastasis(es) are eligible if they have been stable for ≥ 2 months.
o Painful bone metastases, or bone metastases that require immediate therapy.
o Significant and/or symptomatic pleural effusions. Presence of clinically detectable (by physical exam) third-space fluid collections, for example, pleural effusions that cannot be controlled by previous chemotherapy and/or drainage, or other procedures, prior to study entry.
o Known allergies to eggs or soy.
o Significant weight loss (≥ 10% body weight in preceding 6 weeks).
o Known HIV positivity (EBV origin of replication in the pCHEK/HBA2 vector used to modify the vaccine components can trans-activate HIV).
o Serious non-malignant disease (e.g., congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections) or other conditions that, in the opinion of the investigator, would compromise study objectives.
o NCI CTC Grade 3 or 4 peripheral neuropathy at study registration.
o Prior other malignancies (excluding non-melanoma carcinomas of the skin) unless in remission for ≥ 2 years.
o History of psychiatric disorder that would impede ability to give informed consent or adherence to study requirements.
o Pregnant or nursing women, or refusal to practice contraception if of reproductive potential. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
o Known active Epstein-Barr infection within ≤ 60 days of study registration. |
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Method of Generating Random Sequence
Modification(s)
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Computer generated randomization |
Method of Concealment
Modification(s)
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Centralized |
Blinding/Masking
Modification(s)
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Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
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| Outcome |
TimePoints |
| ? Compare the overall survival of subjects with stage III or IV non-small cell lung cancer treated with belagenpumatucel-L (Lucanix?) vs placebo. |
The primary analysis time point for all outcome variables will be the time of the primary analysis
for overall survival. |
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Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Evaluate the progression free survival (PFS) of subjects treated with Lucanix compared to treatment within the Best Support Care (BSC)control group. |
PFS and TTP will be analyzed using the same methods as described for the primary endpoint.PFS will be calculated from the date of randomization to the date of documented tumor
progression (i.e. the date of the initial scan that detects tumor progression) or death from any cause and will be censored at the date of the last contact for subjects who are lost-to-follow-up or
who are alive at the time of analysis. |
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Target Sample Size
Modification(s)
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Total Sample Size="700"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
Modification(s)
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Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
13/04/2009 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/08/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="8"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Other (Terminated) |
Publication Details
Modification(s)
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None |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
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This is a multicenter study. Subjects are stratified according to disease stage (IIIA vs IIIB or IV), response to prior treatment with front-line chemotherapy (stable disease vs partial response or complete response), prior treatment with front-line chemotherapy and radiotherapy (front-line chemotherapy with radiotherapy vs front-line chemotherapy alone), and prior treatment with front-line chemotherapy and other anticancer therapy (front-line chemotherapy with bevacizumab vs front-line chemotherapy alone or in combination with another anticancer agent). Subjects are randomized to 1 of 2 treatment arms. ? Treatment Arm: Subjects receive belagenpumatucel-L (Lucanix?) intradermally (ID) once monthly for 18 months and then once at 21 and 24 months in the absence of disease progression or unacceptable toxicity. ? Control Arm: Subjects receive placebo ID once monthly for 18 months and then once at 21 and 24 months in the absence of disease progression or unacceptable toxicity. Blood samples are collected and analyzed for routine chemistry, cytokines, chemokines, and some instances circulating tumor cells, including response to multiple lung cancer-associated antigens by IFN-γ ELISPOT CD8+ assay; CEA by CD4 class II assay; lung tumor-associated antigens by in vitro proliferation assays; regulatory T-cell (Treg) phenotype by flow cytometry; and Treg function. Subjects complete the Lung Cancer Symptom Scale quality of life questionnaire at baseline, on the days of treatment, 30 days after completion of study treatment, and then every 3 months for 1 year. After completion of study treatment, subjects are followed every 3 months for 1 year and then annually for 4 years. The study treatment period is for 2 years, followed by follow up of 5 years. It is expected that around 70 patients will be enrolled from India. The first patient was enrolled for the study in India on 13-Apr-2009 |