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Gene Therapy in Treating Patients With Unresectable, Recurrent, or Refractory Head and Neck Cancer
This study is ongoing, but not recruiting participants.
First Received: December 10, 1999   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004070
  Purpose

RATIONALE: Inserting the gene for interleukin-12 into a person's cancer cells may make the body build an immune response to kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of gene therapy in treating patients who have unresectable, recurrent, or refractory head and neck cancer.


Condition Intervention Phase
Head and Neck Cancer
Biological: interleukin-12 gene
Phase I
Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer
Drug Information available for: Interleukin-12
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
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)

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 34
Study Start Date: July 1999
Detailed Description:

OBJECTIVES: I. Determine the safety and tolerability of interleukin-12 gene in patients with unresectable, recurrent, or refractory squamous cell carcinoma of the head and neck. II. Evaluate the efficacy of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive interleukin-12 gene by intratumoral injection twice during week 1 and once weekly during weeks 2-7 in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 28-34 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven unresectable, recurrent, or refractory squamous cell carcinoma of the head and neck Primarily stage III or IV Tumor accessible to direct injection No tumor involving major blood vessels or obstructing airway

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 50,000/mm3 Hepatic: No prior or concurrent active liver disease SGOT and SGPT no greater than 3 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease Pulmonary: No respiratory disease that sufficiently influences oxygenation of arterial blood Other: At least 2 weeks since prior infection No concurrent infection No active or clinically relevant viral illness No other malignancies requiring treatment during this study No prior autoimmune disease (e.g., rheumatic disease, Crohn's disease) No allergy to polyvinylpyrrolidone (PVP) or related products No prior psychiatric disability No prior seizures Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior viral based gene therapy, recombinant DNA products, or bacterial plasmids Chemotherapy: At least 28 days since prior chemotherapy No concurrent chemotherapy No chemotherapy during follow up period Endocrine therapy: No concurrent corticosteroids Radiotherapy: At least 28 days since prior radiotherapy No concurrent radiotherapy No radiotherapy during follow up period Surgery: At least 28 days since prior surgery No concurrent surgery No surgery during follow up period Other: At least 30 days since prior investigational drugs No concurrent high dose nonsteroidal antiinflammatory drugs No concurrent immunosuppressive drugs

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004070

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Study Chair: A. Dimitrios Colevas, MD NCI - Investigational Drug Branch
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067274, DFCI-99081, VALENTIS-DFCI-99081, NCI-G99-1578
Study First Received: December 10, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00004070     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Interleukin-12
Nasopharyngeal Carcinoma
Immunologic Factors
Laryngeal Carcinoma
Adjuvants, Immunologic
Carcinoma, Squamous Cell of Head and Neck
Squamous Cell Carcinoma
Angiogenesis Inhibitors
Recurrence
Carcinoma
Hypopharyngeal Cancer
Metastatic Squamous Neck Cancer With Occult Primary
Head and Neck Neoplasms
Epidermoid Carcinoma
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Interleukin-12
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Adjuvants, Immunologic
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Therapeutic Uses
Head and Neck Neoplasms
Growth Inhibitors
Angiogenesis Modulating Agents
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009