Completed
A Multi-Center, Open-Label, Multiple Administration, Rising Dose Study of the Safety, Tolerability, and Efficacy of IL-12 Gene Medicine in Patients With Unresectable or Recurrent/Refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)
What is being tested
IL-12
+ IL-12
+ IL-12
Biological
Who is being recruted
Carcinoma+5
+ Carcinoma, Squamous Cell
+ Neoplasms
Over 18 Years
+26 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1 & 2
Interventional
Study Start: July 1999
Summary
Principal SponsorDana-Farber Cancer Institute
Last updated: April 20, 2017
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 1999
Actual date on which the first participant was enrolled.This is a Phase I/II trial to study the effectiveness of gene therapy in treating patients who have unresectable, recurrent, or refractory head and neck cancer.
Principal SponsorDana-Farber Cancer Institute
Last updated: April 20, 2017
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
7 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
CarcinomaCarcinoma, Squamous CellNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialSquamous Cell Carcinoma of Head and NeckHead and Neck Neoplasms
Criteria
7 inclusion criteria required to participate
Able to give written informed consent
Disease: biopsy-proven unresectable or recurrent/refractory squamoussell_eareinoma_of_the:head-and-neck-(usualLy -Stage-Di-or-IV) -
Females must be non-pregnant and non-lactating and either surgically sterile (via hysterectomy or bilateral tubal ligation), at least one year post-menopausal, or using acceptable methods of contraception for the duration of the study
Karnofsky performance of at least 70%
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19 exclusion criteria prevent from participating
Active liver disease with transaminases > 3 times the upper limit of normal
Active or clinically-relevant viral illnesses
Chemotherapy, radiotherapy or immunotherapy within 28 days of study entry or during the course of study
History of autoimmune disease, including rheumatic disease, Crohn's disease, etc.
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalThe dosing schedule will consist of eight injections 3 mg/ml of formulated plasmid over a seven week period.
Group II
ExperimentalThe dosing schedule will consist of eight injections 6mg/ml of formulated plasmid over a seven week period.
Group III
ExperimentalThe dosing schedule will consist of eight injections over a seven week period of formulated plasmid at the MTD established in the phase I portion.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Beth Israel Deaconess Medical Center
Boston, United StatesCompleted2 Study Centers