Head and Neck CancerPhase 2NCT00003257
Gene Therapy in Treating Patients With Recurrent Head and Neck Cancer
A Phase 2 study testing Ad5CMV-p53 gene in people with Head and Neck Cancer, run by Aventis Pharmaceuticals at 10 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Ad5CMV-p53 gene
- How many people
- 39 participants
- Where
- 10 sitesUnited States
- Study dates
- Jan 1998to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
Clinical Sciences Building
Chicago, Illinois, 60612
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
University of Colorado Cancer Center
Denver, Colorado, 80262
University of Connecticut School of Medicine
Farmington, Connecticut, 06032
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
Tulane University School of Medicine
New Orleans, Louisiana, 70112
Sidney Kimmel Cancer Center
San Diego, California, 92121
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, 10461
About this study
Official title: 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)
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.
Read the detailed description
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
- Head and Neck Cancer
- Being tested
- Ad5CMV-p53 gene
- Keywords
- 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
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad5CMV-p53 geneBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2004 (estimated)
- Study startJan 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aventis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lyndah Dreiling, MD, Study chair, Aventis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003257
- Sponsor's protocol ID
- CDR0000066148
- Other IDs
- AVENTIS-T-202, MCC-11653, RP-T-202, NCI-V98-1394
- Status last verified
- Apr 2000
- First submitted
- 1 Nov 1999
- Last updated
- 4 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT00003257
- Acronym / sponsor ID
- CDR0000066148
- Conditions
- Head and Neck Cancer
- Keywords
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Aventis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 1998
- First posted
- 10 Sep 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ad5CMV-p53 gene | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lyndah Dreiling, MD study chair
Aventis Pharmaceuticals
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ad5CMV-p53 gene in people with Head and Neck Cancer, run by Aventis Pharmaceuticals at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2013.