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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Thomas V. McCaffrey, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Federal Government

Study ID:

VALENTIS-IL2-2001

NCT ID:

NCT00006033

Start Date:

June 2000

Completion Date:

June 2004

Related Keywords:

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

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612