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Original TRDS for trail "Efficacy and Safety Study of Leukocyte Interleukin, Injection (LI) to Treat Cancer of the Oral Cavity " created on Oct 20, 2016


SLCTR Registration Number

SLCTR/2014/017

Date of Registration

25 Aug 2014

The date of last modification

Oct 20, 2016

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Application Summary

Scientific Title of Trial

A Phase III, Open-label, Randomized, Multi-center Study of the Effects of Leukocyte Interleukin, Injection [Multikine] Plus Standard of Care (Surgery + Radiotherapy or Surgery + Concurrent Chemoradiotherapy) in Subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity / Soft Palate Versus Standard of Care Only

Public Title of Trial

Efficacy and Safety Study of Leukocyte Interleukin, Injection (LI) to Treat Cancer of the Oral Cavity

Disease or Health Condition(s) Studied

Squamous Cell Carcinoma of the Oral Cavity and soft palate

Scientific Acronym

None

Public Acronym

None

Brief title

None

Universal Trial Number

None

Any other number(s) assigned to the trial and issuing authority

ClinicalTrials.gov Identifier: NCT01265849; EudraCT Number: 2010-019952-35


Trial Details

What is the research question being addressed?

Is Leukocyte Interleukin administered in combination with cyclophosphamide, indomethacin and zinc (CIZ) prior to standard of care therapy (surgery followed by radiotherapy or concurrent radiochemotherapy) safe and will it increase the overall survival of subjects with previously untreated squamous cell carcinoma of the oral cavity or soft palate at a median of 3 years ?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Masking not used

Control

Standard therapy

Assignment

Parallel

Purpose

Treatment

Study Phase

Phase 3

Intervention(s) planned

Interventions will be as follows 1. Leukocyte Interleukin (Multikine): 400IU Multikine (2.0mL total daily) 1.0 mL peritumoral, 1.0 mL perilymphatic will be administered 5 times a week for 3 weeks

  1. Cyclophosphamide, indomethacin and zinc (CIZ treatment) • Cyclophosphamide 300mg/m2 (IV bolus) 3 days prior to treatment with Multikine • Indomethacin 25mg capsules t.i.d., from day 1 of Multikine treatment up to 1 day prior to surgery • Daily zinc supplementation as found in a standard multivitamin formulation (> or = to 15mg but not > 40mg) from day 1 of Multikine treatment up to 1 day prior to surgery

  2. Standard of care (SOC): surgery of tumor and involved lymph nodes + radiotherapy or surgery + concurrent chemoradiotherapy

The participants will be randomized into 3 arms Arm 1 : Leukocyte Interleukin (Multikine) + cyclophosphamide, indomethacin and zinc (CIZ) + Standard of care (SOC) Arm 2 : Multikine + SOC Arm 3 : SOC only

Inclusion criteria

Ages Eligible for Study : 18 Years and older Genders Eligible for Study : Both Accepts Healthy Volunteers: No

  1. Untreated SCCHN of oral cavity/soft palate, categories T1N1-2M0,T2N1-2M0,T3N0-2M0,T4N0-2M0 (T4 allowed only if invasion of mandible is negligible) scheduled for SOC
  2. Primary tumor and any positive node(s)measurable in 2 dimensions
  3. Normal immune function
  4. No immunosuppressives with 1 year
  5. Karnofsky Performance Status (KPS) >70
  6. Age>18
  7. Male or Female (non-pregnant)
  8. Life expectancy >6 months
  9. Able to take oral medication
  10. Able to provide informed consent

Exclusion criteria

  1. Subjects to be treated with other than SOC
  2. Tumor invasion of bone (also see inclusion criteria)
  3. Tumor classifications T1N0, T2N0, T4N3, any TN classification with M1
  4. Tumors in locations other than those specified in inclusion criteria
  5. Active peptic ulcer
  6. Prior resection of jugular nodes ipsilateral to tumor
  7. Acute or chronic viral, bacterial immune or other disease associated with abnormal immune function
  8. Subjects on hemodialysis or peritoneal dialysis
  9. History of asthma
  10. Any condition that in the opinion of the investigator would cause the subject to be unable to participate or tolerate the protocol regimen

Primary outcome(s)

1.

Overall Survival (OS) in LI + CIZ + SOC vs. SOC OS will be assessed using Kaplan-Meier life-table

[

From randomization up to 3 years

]

Secondary outcome(s)

1.

  1. Progression Free Survival (PFS) in LI + CIZ + SOC vs.SOC [PFS will be assessed using Kaplan-Meier life-table and compared using a logrank test ]

  2. Local regional control (LRC) in LI + CIZ + SOC vs. SOC [LRC will be assessed by classifying the first evidence of progression in local and distal sites for the control group and for the LI treated group].

  3. Quality of Life (QOL) in LI + CIZ + SOC vs. SOC [QOL will be based on the EORTC QLOQ-C30 and EORTC QLQ-H&N35].

[

From randomization up to 3 years

]

Target number/sample size

Global 880; Sri Lanka 300

Countries of recruitment

Canada, Croatia, Hungary, India, Israel, Poland, Russian Federation, Serbia, Sri Lanka, Taiwan, Province of China, Ukraine, United States

Anticipated start date

2014-08-25

Anticipated end date

2018-08-25

Date of first enrollment

Date of study completion

Recruitment status

Suspended

Funding source

CEL-SCI Corporation, USA

Regulatory approvals


State of Ethics Review Approval

Status

Date of Approval

Approval number

Details of Ethics Review Committee

Name:
Institutional Address:
Telephone:
Email:

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Dr. Mahendra Perera / Principal Investigator
Consultant Oncologist and Radiotherapist
National Cancer Institute, Maharagama, Sri Lanka
+94112850253, +94115219290
+94777668698
+94115762244
mahenp3@gmail.com

Contact Person for Public Queries

Dr. Mahendra Perera / Principal Investigator
Consultant Oncologist and Radiotherapist
National Cancer Institute, Maharagama, Sri Lanka
+94112850253, +94115219290
+94777668698
+94115762244
mahenp3@gmail.com

Primary study sponsor/organization

Dr. E Talor

CEL-SCI Corporation 8229 Boone Boulevard Suite 802 Vienna, Virginia 22182 U.S.A
+1(703)-506-9460
+1(703)-506-9471
etalor@cel-sci.com
http://www.cel-sci.com

Secondary study sponsor (If any)

J Cipriano

CEL-SCI Corporation 8229 Boone Boulevard Suite 802 Vienna, Virginia 22182 U.S.A
+1(703)-506-9460
+1(703)-506-9471
jcipriano@cel-sci.com
http://www.cel-sci.com

Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results