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Gene Therapy in Treating Patients With Recurrent Head and Neck Cancer

NCT ID: NCT00003257

Last Updated: 2013-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-01-31

Brief Summary

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RATIONALE: Inserting the gene for p53 into a person's tumor may improve the body's ability to fight cancer or make the cancer more sensitive to chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating patients who have recurrent head and neck cancer.

Detailed Description

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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.

Conditions

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Head and Neck Cancer

Keywords

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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

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Ad5CMV-p53 gene

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aventis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Principal Investigators

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Lyndah Dreiling, MD

Role: STUDY_CHAIR

Aventis Pharmaceuticals

Locations

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Sidney Kimmel Cancer Center

San Diego, California, United States

Site Status

University of Colorado Cancer Center

Denver, Colorado, United States

Site Status

University of Connecticut School of Medicine

Farmington, Connecticut, United States

Site Status

Clinical Sciences Building

Chicago, Illinois, United States

Site Status

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Tulane University School of Medicine

New Orleans, Louisiana, United States

Site Status

Marlene & Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, United States

Site Status

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, United States

Site Status

Simmons Cancer Center - Dallas

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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AVENTIS-T-202

Identifier Type: -

Identifier Source: secondary_id

MCC-11653

Identifier Type: -

Identifier Source: secondary_id

RP-T-202

Identifier Type: -

Identifier Source: secondary_id

NCI-V98-1394

Identifier Type: -

Identifier Source: secondary_id

CDR0000066148

Identifier Type: -

Identifier Source: org_study_id