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Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004070 |
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 |
Drug: interleukin-12 gene |
Phase I Phase II |
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) |
Estimated Enrollment: | 34 |
Study Start Date: | July 1999 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Study Chair: | A. Dimitrios Colevas, MD | NCI - Investigational Drug Branch |
Study ID Numbers: | CDR0000067274, DFCI-99081, VALENTIS-DFCI-99081, NCI-G99-1578 |
Study First Received: | December 10, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00004070 |
Health Authority: | United States: Federal Government |
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 |
Interleukin-12 Squamous cell carcinoma Recurrence Carcinoma Epidermoid carcinoma Nasopharyngeal carcinoma Head and Neck Neoplasms Metastatic squamous neck cancer with occult primary |
Carcinoma, squamous cell Laryngeal carcinoma Hypopharyngeal cancer Neoplasms, Squamous Cell Carcinoma, Squamous Cell Carcinoma, squamous cell of head and neck Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Adjuvants, Immunologic Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |