Know Cancer

or
forgot password

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)


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

Trial Information

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)


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

A. Dimitrios Colevas, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Investigational Drug Branch

Authority:

United States: Federal Government

Study ID:

CDR0000067274

NCT ID:

NCT00004070

Start Date:

July 1999

Completion Date:

Related Keywords:

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

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115