- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006033
Interleukin-2 Gene or Methotrexate in Treating Patients With Recurrent or Refractory Stage III or Stage IV Head and Neck Cancer
Protocol IL-2001: A Multi-Center, Open-Label, Randomized Study of the Efficacy and Safety of Multiple Intratumoral Injections of hIl-2 Plasmid (1.8 mg) Formulated With DOTMA/Cholesterol [Ratio 1:0.5(-/+)] Liposomes in Patients With Unresctable or Recurrent/Refractory Squamous Cell Carcinoma of the Head and Neck
RATIONALE: Inserting the gene for interleukin-2 into head and neck cancer cells may make the body build an immune response to kill the tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether the interleukin-2 gene is more effective than methotrexate for advanced head and neck cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of the interleukin-2 gene with that of methotrexate in treating patients who have recurrent or refractory stage III or stage IV head and neck cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES: I. Compare the efficacy of interleukin-2 gene versus methotrexate in patients with recurrent or refractory squamous cell carcinoma of the head and neck. II. Determine the safety and tolerability of interleukin-2 gene in these patients. III. Compare the quality of life of these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive interleukin-2 gene intratumorally on days 1 and 4 of week 1, and then once weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive methotrexate IV once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at the beginning of the study and at weeks 5, 13, 17 and 25. Patients are followed every 2-3 weeks for up to 18 weeks.
PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center and Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory stage III or IV squamous cell carcinoma of the head and neck Failed first line chemotherapy for advanced or recurrent disease Measurable disease accessible to direct injection Tumor must not be involving major blood vessels or obstructing the airway
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: No active liver disease Transaminases no greater than 3 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance greater than 60 mL/min Cardiovascular: No New York Heart Association class III or IV heart disease Pulmonary: No respiratory disease sufficient enough to influence oxygenation of arterial blood Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception At least 2 weeks since prior infection No concurrent infection No active or clinically relevant viral illness No clinical condition (e.g., effusions or ascites) that would preclude methotrexate administration No known hypersensitivity to antimetabolite chemotherapeutic agents No rheumatic or autoimmune disease No other concurrent malignancies requiring treatment
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior antitumor therapy with recombinant DNA products including viral based gene therapy or bacterial plasmids At least 28 days since prior immunotherapy and at least 14 days since complete recovery At least 14 days since complete recovery from prior antiviral therapy No concurrent hematopoietic growth factors (filgrastim (G-CSF) or sargramostim (GM-CSF)) No concurrent recombinant interleukin-2 therapy Prior G-CSF or GM-CSF adjunct therapy allowed Chemotherapy: See Disease Characteristics At least 28 days since prior chemotherapy and at least 14 days since complete recovery No prior methotrexate Endocrine therapy: No concurrent corticosteroids Radiotherapy: At least 28 days since prior radiotherapy and at least 14 days since complete recovery Surgery: No planned surgical resection Other: At least 14 days since complete recovery from prior antibiotic therapy No concurrent high dose nonsteroidal antiinflammatories or immunosuppressive drugs At least 30 days since prior investigational drugs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Thomas V. McCaffrey, MD, PhD, H. Lee Moffitt Cancer Center and Research Institute
Study record dates
Study Major Dates
Study Start
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- recurrent metastatic squamous neck cancer with occult primary
- 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
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Site
- Head and Neck Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Methotrexate
- Interleukin-2
Other Study ID Numbers
- VALENTIS-IL2-2001
- MCC-12051
- MCC-IRB-5482
- CDR0000068046 (REGISTRY: PDQ (Physician Data Query))
- NCI-G00-1810
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Head and Neck Cancer
-
Robert FerrisAmgenCompletedHead and Neck Cancer | Cancer of Head and Neck | Head Cancer | Neck Cancer | Neoplasms, Head and Neck | Cancer of the Head and Neck | Cancer of Neck | Upper Aerodigestive Tract Neoplasms | Neck Neoplasms | Cancer of the Head | Cancer of the Neck | UADT Neoplasms | Cancer of Head | Head Neoplasms | Head, Neck Neoplasms | Neoplasms, Head and other conditionsUnited States
-
Assiut UniversityRecruitingHead and Neck Cancer | Head and Neck Neoplasms | Cancer of Head and Neck | Neoplasms, Head and Neck | Cancer of the Head and NeckEgypt
-
Mayo ClinicRecruitingCancer Head Neck | Cancer Neck | Cancer, HeadUnited States
-
IRCCS Policlinico S. MatteoNestlé Health Science Spain; Akern SrlCompletedHead-neck CancerItaly
-
University of California, San FranciscoCompleted
-
Chinook Therapeutics, Inc. (formerly Aduro)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedHead And Neck CancerUnited States
-
National Cancer Institute (NCI)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
-
Radboud University Medical CenterUnknown
-
Centre Oscar LambretUnknownEpidermoid Head and Neck CancerFrance
Clinical Trials on methotrexate
-
University Hospital, MontpellierPfizer; Hôpital CochinCompletedRheumatoid ArthritisFrance, Monaco
-
Nicolaus Copernicus UniversityCompleted
-
Amneal Pharmaceuticals, LLCAccutest Research Laboratories (I) Pvt. Ltd.Unknown
-
Hee Young JuNot yet recruitingLymphoblastic Leukemia in Children
-
PfizerCompletedRheumatoid ArthritisUnited States, Mexico, Argentina, Chile, Croatia, Czech Republic, Hungary, Poland, Puerto Rico
-
PfizerCompletedRhematoid ArthritisSpain, United Kingdom, United States, Korea, Republic of, Poland, Israel, Australia, Taiwan, Thailand, South Africa, Bulgaria, Estonia, Latvia, Philippines, Canada, Romania, Russian Federation, Turkey, Mexico, Bosnia and Herzegovina and more
-
Cairo UniversityCompleted
-
Chugai Pharma TaiwanCompletedRheumatoid Arthritis (RA)Taiwan
-
CHA UniversityCompleted
-
Mitsubishi Tanabe Pharma CorporationCompleted