Gene Therapy in Treating Patients With Unresectable, Recurrent, or Refractory Head and Neck Cancer

Dana-Farber Cancer Institute

Status and phase: Completed; Phase 2; Phase 1

Conditions: Head and Neck Cancer

Treatments: Biological: IL-12

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004070

CDR0000067274 (Other Identifier)

VALENTIS-DFCI-99081

P30CA006516 (U.S. NIH Grant/Contract)

NCI-G99-1578

99-081

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 3 patient groups

IL-12 Injection 3mg/ml [Phase I]

Experimental group

Description:

The dosing schedule will consist of eight injections 3 mg/ml of formulated plasmid over a seven week period.

Treatment:

Biological: IL-12

IL-12 Injection 6mg/ml [Phase I]

Experimental group

Description:

The dosing schedule will consist of eight injections 6mg/ml of formulated plasmid over a seven week period.

Treatment:

Biological: IL-12

IL-12 Injection MTD [Phase II]

Experimental group

Description:

The dosing schedule will consist of eight injections over a seven week period of formulated plasmid at the MTD established in the phase I portion.

Treatment:

Biological: IL-12