Clinical trial NCT00004070: Gene Therapy in Treating Patients With Unresectable, Recurrent, or Refractory Head and Neck Cancer
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Head and Neck Cancer
Keywords: recurrent metastatic squamous neck cancer with occult primary
metastatic squamous neck cancer with occult primary squamous cell carcinoma
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
recurrent squamous cell carcinoma of the nasopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-06-04
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This is a non-randomize phase I/II where patients are directly assigned treatment.
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Scheduled surgical resection
* History of autoimmune disease, including rheumatic disease, Crohn's disease, etc. ,
* Known allergy to polyvinylpyrrofidone (PVP) or related products
* History of psychiatric disabilities or seizures.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) [Phase I]
timeFrame: Assessed during therapy up to 7 weeks.
measure: Dose Limiting Toxicity (DLT) [Phase I]
timeFrame: Assessed during therapy up to 7 weeks.
measure: Grade 3-4 Toxicity Rate [Phase II]
timeFrame: Assessed until last scheduled on-study visit up to visit 12/day 112.
Secondary outcomes:
measure: Time to Progressive Disease (TTP) [Phase III]
timeFrame: Measurement by CT occurs up to the earliest of progression, death or 4 months after enrollment of last patient.
measure: Response [Phase II]
timeFrame: Measurement by CT occurs up to visit 12/day 112.
measure: Overall Survival (OS) [Phase II]
timeFrame: Measurement by CT occurs up to the earliest of progression, death or 4 months after enrollment of last patient.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: NCI-Investigational Drug Branch
name: A. Dimitrios Colevas, MD
role: STUDY_CHAIR
References: