Gene Therapy in Treating Patients With Unresectable, Recurrent, or Refractory Head and Neck Cancer
NCT ID: NCT00004070
Last Updated: 2017-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
7 participants
INTERVENTIONAL
1999-07-31
2000-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IL-12 Injection 3mg/ml [Phase I]
The dosing schedule will consist of eight injections 3 mg/ml of formulated plasmid over a seven week period.
IL-12
IL-12 Injection 6mg/ml [Phase I]
The dosing schedule will consist of eight injections 6mg/ml of formulated plasmid over a seven week period.
IL-12
IL-12 Injection MTD [Phase II]
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.
IL-12
Interventions
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IL-12
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Robert I. Haddad, MD
Haddad, Robert MD
Principal Investigators
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A. Dimitrios Colevas, MD
Role: STUDY_CHAIR
NCI-Investigational Drug Branch
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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VALENTIS-DFCI-99081
Identifier Type: -
Identifier Source: secondary_id
NCI-G99-1578
Identifier Type: -
Identifier Source: secondary_id
CDR0000067274
Identifier Type: OTHER
Identifier Source: secondary_id
99-081
Identifier Type: -
Identifier Source: org_study_id
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