Gene Therapy in Treating Patients With Unresectable, Recurrent, or Refractory Head and Neck Cancer
Recruitment status was Active, not recruiting
|First Received Date ICMJE||December 10, 1999|
|Last Updated Date||February 6, 2009|
|Start Date ICMJE||July 1999|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00004070 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Gene Therapy in Treating Patients With Unresectable, Recurrent, or Refractory Head and Neck Cancer|
|Official Title ICMJE||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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1
|Study Design ICMJE||Primary Purpose: Treatment|
|Condition ICMJE||Head and Neck Cancer|
|Intervention ICMJE||Biological: interleukin-12 gene|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||34|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00004070|
|Other Study ID Numbers ICMJE||CDR0000067274, DFCI-99081, VALENTIS-DFCI-99081, NCI-G99-1578|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Dana-Farber Cancer Institute|
|Collaborators ICMJE||National Cancer Institute (NCI)|
|Information Provided By||National Cancer Institute (NCI)|
|Verification Date||January 2001|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP