Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2001 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004070
First received: December 10, 1999
Last updated: February 6, 2009
Last verified: January 2001

December 10, 1999
February 6, 2009
July 1999
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00004070 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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)

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.

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.

Interventional
Phase 1
Phase 2
Primary Purpose: Treatment
Head and Neck Cancer
Biological: interleukin-12 gene
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
34
Not Provided
Not Provided

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004070
CDR0000067274, DFCI-99081, VALENTIS-DFCI-99081, NCI-G99-1578
Not Provided
Not Provided
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study Chair: A. Dimitrios Colevas, MD NCI - Investigational Drug Branch
National Cancer Institute (NCI)
January 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP