Gene Therapy in Treating Patients With Advanced Head and Neck Cancer

NCT00009841 | Completed Phase 1

• 4 other identifiers: PCI-98025CDR0000068414PCI-IRB-980771NCI-G00-1904
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Gene therapy may kill cancer cells by inhibiting a gene that promotes the development and growth of cancer. PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have advanced head and neck cancer.

Conditions

Head and Neck Cancer

Keywords

untreated metastatic squamous neck cancer with occult primary; recurrent metastatic squamous neck cancer with occult primary; metastatic squamous neck cancer with occult primary squamous cell carcinoma; stage IV squamous cell carcinoma of the lip and oral cavity; recurrent squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the nasopharynx; recurrent squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity

Interventions

EGFR antisense DNA BIOLOGICAL

growth factor antagonist therapy BIOLOGICAL

DC-cholesterol liposome DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically confirmed advanced squamous cell carcinoma of the head and neck Primary or recurrent disease Not amenable to standard therapy (surgery, chemotherapy, or radiotherapy) Second primary lesions allowed Brain metastases allowed after definitive radiotherapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 8 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT no greater than 4 times normal Renal: Creatinine no greater than 2 mg/dL Calcium no greater than 10.5 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception (double-barrier method and oral contraception) prior to, during, and for at least 2 weeks after study PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213-3489, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Jennifer R. Grandis, MD

  University of Pittsburgh

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2001
• First Posted: April 2, 2004
• Study Start: March 1, 1999
• Primary Completion: March 1, 2002
• Study Completion: March 1, 2002
• Last Updated: February 12, 2016

Record last verified: 2002-06

Locations

US (1)