NCT00017173

Brief Summary

RATIONALE: Inserting the p53 gene into a person's cancer cells may improve the body's ability to fight cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy with the p53 gene may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of gene therapy plus surgery followed by cisplatin and radiation therapy in treating patients who have newly diagnosed resectable stage III or stage IV cancer of the mouth or throat.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2 head-and-neck-cancer

Timeline
Completed

Started Feb 2003

Longer than P75 for phase_2 head-and-neck-cancer

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2001

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2003

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

4.2 years

First QC Date

June 6, 2001

Last Update Submit

June 12, 2012

Conditions

Head and Neck Cancer

Keywords

stage III squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the lip and oral cavitystage III squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the oropharynxstage III squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the larynxstage IV squamous cell carcinoma of the hypopharynxstage IV verrucous carcinoma of the larynx

Outcome Measures

Primary Outcomes (1)

  • Feasibility

    accrual rate and percentage of patients successfully receiving the required doses of INGN 201

    1 year

Secondary Outcomes (1)

  • Progression-free survival from time of registration until disease progression

    two years

Study Arms (1)

surgery with INGN 201 followed by chemo/RT

EXPERIMENTAL

intraoperative and postoperative injections of INGN 201 into the tumor bed, followed by cisplatin and radiation therapy

Biological: Ad5CMV-p53 geneDrug: cisplatinProcedure: conventional surgeryRadiation: radiation therapy

Interventions

Ad5CMV-p53 geneBIOLOGICAL

2 intraoperative and one post-operative injection of Ad5CMV-p53.

Also known as: INGN 201
surgery with INGN 201 followed by chemo/RT
cisplatinDRUG

100 mg/m2 IV Day 1 every 21 days for 3 cycles

Also known as: platinol
surgery with INGN 201 followed by chemo/RT
conventional surgeryPROCEDURE

conventional surgery

Also known as: surgery
surgery with INGN 201 followed by chemo/RT
radiation therapyRADIATION

200 cGy per day Days 105 every week for 6 weeks

Also known as: RT
surgery with INGN 201 followed by chemo/RT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed high-risk/limited stage III or IV squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx * Newly diagnosed * Previously untreated * Considered surgically resectable * Evidence of regional lymph node metastases (N1-N3) * No distant metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) * SGOT or SGPT no greater than 3 times ULN * Hepatitis B surface antigen negative * Hepatitis C antibody negative Renal: * Creatinine no greater than 2 times ULN * Creatinine clearance at least 60 mL/min Other: * Magnesium normal (magnesium supplement allowed) * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission * HIV negative * Not pregnant or nursing * Patients must use effective barrier contraception and prevent bodily fluid transmission during and for 28 days after Ad5CMV-p53 gene administration PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * No concurrent intensity-modulated radiotherapy Surgery: * Not specified

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

Sponsors & Collaborators

Study Sites (3)

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

Markey Cancer Center at University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536-0293, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Related Publications (1)

  • Yoo GH, Moon J, Leblanc M, Lonardo F, Urba S, Kim H, Hanna E, Tsue T, Valentino J, Ensley J, Wolf G. A phase 2 trial of surgery with perioperative INGN 201 (Ad5CMV-p53) gene therapy followed by chemoradiotherapy for advanced, resectable squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx: report of the Southwest Oncology Group. Arch Otolaryngol Head Neck Surg. 2009 Sep;135(9):869-74. doi: 10.1001/archoto.2009.122.

    PMID: 19770418DERIVED

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

advexinCisplatinSurgical Procedures, OperativeRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTherapeutics

Study Officials

  • George H. Yoo, MD

    Barbara Ann Karmanos Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2001

First Posted

January 27, 2003

Study Start

February 1, 2003

Primary Completion

May 1, 2007

Study Completion

July 1, 2011

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

US(3)