Interleukin-2 Gene or Methotrexate in Treating Patients With Recurrent or Refractory Stage III or Stage IV Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006033
• Other study ID #: VALENTIS-IL2-2001
• Secondary ID: MCC-12051MCC-IRB
• Status: Completed
• Phase: Phase 2
• First received: July 5, 2000
• Last updated: May 29, 2013
• Start date: June 2000
• Est. completion date: June 2004

Study information

• Verified date: January 2001
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Biological:
• gene therapy

• interleukin-2 gene

Drug:
• methotrexate

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,