Gene Therapy in Treating Patients With Unresectable, Recurrent, or Refractory Head and Neck Cancer
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)
5 other identifiers
interventional
7
1 country
2
Brief Summary
Participant with squamous cell cancer of head and neck are invited to participate in this study. In this study the investigators will be Inserting the gene for interleukin-12 into a person's cancer cells with the anticipation to make the body build an immune response to kill more tumor cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 head-and-neck-cancer
Started Jul 1999
Shorter than P25 for phase_1 head-and-neck-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1999
CompletedFirst Submitted
Initial submission to the registry
December 10, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2000
CompletedFirst Posted
Study publicly available on registry
June 4, 2004
CompletedApril 20, 2017
April 1, 2017
1.3 years
December 10, 1999
April 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Maximum Tolerated Dose (MTD) [Phase I]
The MTD of IL-12 gene medicine is determined by the number of participants who experience a dose limiting toxicity (DLT). The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed in the two dose levels planned then evaluation of a third escalation will be considered. If the MTD is not reached, the dose selected for use in the phase II portion will be defined as the maximum volume that can be reasonably and safely injected into the tumor.
Assessed during therapy up to 7 weeks.
Dose Limiting Toxicity (DLT) [Phase I]
A DLT was defined as grade 4 hematologic toxicity greater than 5 days duration or grade 3 or higher non-hematologic toxicity based on NCI common toxicity criteria (CTCAEv2).
Assessed during therapy up to 7 weeks.
Grade 3-4 Toxicity Rate [Phase II]
All Grade 3-4 events based on CTCAEv2 as reported on case report forms.
Assessed until last scheduled on-study visit up to visit 12/day 112.
Secondary Outcomes (3)
Time to Progressive Disease (TTP) [Phase III]
Measurement by CT occurs up to the earliest of progression, death or 4 months after enrollment of last patient.
Response [Phase II]
Measurement by CT occurs up to visit 12/day 112.
Overall Survival (OS) [Phase II]
Measurement by CT occurs up to the earliest of progression, death or 4 months after enrollment of last patient.
Study Arms (3)
IL-12 Injection 3mg/ml [Phase I]
EXPERIMENTALThe dosing schedule will consist of eight injections 3 mg/ml of formulated plasmid over a seven week period.
IL-12 Injection 6mg/ml [Phase I]
EXPERIMENTALThe dosing schedule will consist of eight injections 6mg/ml of formulated plasmid over a seven week period.
IL-12 Injection MTD [Phase II]
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- Male subjects must be surgically sterile or using an acceptable method of contraception for the duration of the study.
- Disease: biopsy-proven unresectable or recurrent/refractory squamoussell\_eareinoma\_of\_the:head-and-neck-(usualLy -Stage-Di-or-IV) -
- Tumor accessible to direct injection
- Karnofsky performance of at least 70%
- Life expectancy of at least three months
- Able to give written informed consent
You may not qualify if:
- Infection (concurrent or within previous 2 weeks)
- Active or clinically-relevant viral illnesses.
- Use of corticosteroids, high-dose non-steroidal antiinflammatory, or immunosuppressive drugs
- Chemotherapy, radiotherapy or immunotherapy within 28 days of study entry or during the course of study
- Respiratory disease sufficient to influence oxygenation of arterial blood
- Active liver disease with transaminases \>3 times the upper limit of normal
- Previous history of liver disease
- NYHA Class EU or greater heart failure
- Serum creatinine of greater than 1.5 times the upper limit of normal
- Polymorphonuclear neutrophilic leukocyte count \<3,000/mm3
- Platelet count \<50,000/mm 3
- Tumor involving major blood vessels or obstructing the airway
- Previous treatment with viral-based gene therapy, recombinant DNA products, or bacterial plasmids
- Use of an investigational drug within 30 days of screening
- Other malignancies requiring treatment during the study
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
A. Dimitrios Colevas, MD
NCI-Investigational Drug Branch
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Haddad, Robert MD
Study Record Dates
First Submitted
December 10, 1999
First Posted
June 4, 2004
Study Start
July 1, 1999
Primary Completion
November 1, 2000
Study Completion
December 1, 2000
Last Updated
April 20, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share