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A Phase II, Multicenter, Open Label Study to Evaluate Effectiveness and Safety of AdCMV-p53 Administered by Intra-Tumoral Injections in 39 Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)


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

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Trial Information

A Phase II, Multicenter, Open Label Study to Evaluate Effectiveness and Safety of AdCMV-p53 Administered by Intra-Tumoral Injections in 39 Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)


OBJECTIVES: I. Estimate the objective response rate of Ad5CMV-p53 in patients with recurrent
squamous cell carcinoma of the head and neck. II. Evaluate the duration of response, time to
disease progression, and overall survival of these patients after this treatment. III.
Evaluate the effectiveness of Ad5CMV-p53 in reducing cancer morbidity (pain assessment,
analgesic consumption, and Karnofsky performance status). IV. Assess the quality of life of
these patients receiving this treatment.

OUTLINE: This is a multicenter, open label study. All patients receive direct intratumoral
injections of Ad5CMV-p53 on days 1, 2, and 3 of each 4-week treatment course. Patients are
treated for at least 2 courses barring local disease progression or unacceptable adverse
events; patients with responding or stable disease receive a maximum of 12 courses. Patients
are evaluated for safety 4 weeks from the completion of the last treatment. Quality of life
is assessed before, during, and after treatment. Patients are followed every 2 months for up
to 18 months or until death.

PROJECTED ACCRUAL: A maximum of 39 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the head and
neck (SCCHN) Recurrent disease documented by histology or cytology (excluding
endolaryngeal recurrence) following first line therapy with curative intent, such as:
Radiation (at least 5000 cGy by standard methodology) and/or Surgery (definitive resection
with postoperative radiation as indicated) Lesions accessible to intratumoral injections
Bidimensionally measurable disease The sum of the products of the bidirectional
measurements for all bidimensionally measurable lesions must be not greater than 30 cm2
The sum of the longest diameters of all measurable lesions must be not greater than 10 cm
No CNS metastasis Tumor tissue from biopsy of primary or recurrent tumor must be available
to determine p53 mutation status

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: Greater than 12 weeks Hematopoietic: Platelet count at least 100,000/mm3
Absolute neutrophil count at least 2,000/mm3 Hepatic: Total bilirubin no greater than
upper limit of normal (ULN) AST/SGOT and/or ALT/SGPT no greater than 1.5 times ULN
Alkaline phosphatase no greater than 5 times ULN Renal: Not specified Other: Not pregnant
or nursing Barrier contraception required during treatment Negative for HIV 1, HIV 2,
hepatitis B, and hepatitis C At least 2 years since prior malignancy, other than SCCHN No
contact with former tissue or organ transplant recipients or persons with severe
immunodeficiency disease within 28 days following final dose of study drug No serious
concurrent medical conditions No active uncontrolled infection

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunostimulating drugs No prior
autologous or allogeneic organ or tissue transplant Chemotherapy: At least 4 weeks since
prior chemotherapy At least 6 weeks since nitrosourea or mitomycin No other concurrent
chemotherapy Endocrine therapy: No concurrent nontopical corticosteroids unless chronic
(at least 6 months) at low doses (no greater than 10 mg of oral prednisone) Radiotherapy:
See Disease Characteristics At least 4 weeks since radiotherapy to measurable disease
sites, unless progressive disease No concurrent radiotherapy to disease sites receiving
study drug injections Surgery: See Disease Characteristics No concurrent surgery to
disease sites receiving study drug injections Other: No concurrent high dose steroids At
least 4 weeks since experimental therapy No concurrent other experimental drugs or therapy
No prior gene therapy using adenoviral vectors

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Lyndah Dreiling, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Aventis Pharmaceuticals

Authority:

United States: Federal Government

Study ID:

CDR0000066148

NCT ID:

NCT00003257

Start Date:

January 1998

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • recurrent metastatic squamous neck cancer with occult primary
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
University of Colorado Cancer CenterDenver, Colorado  80262
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Tulane University School of MedicineNew Orleans, Louisiana  70112
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Sidney Kimmel Cancer CenterSan Diego, California  92121
Clinical Sciences BuildingChicago, Illinois  60612
University of Connecticut School of MedicineFarmington, Connecticut  06032