- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00003257
Gene Therapy in Treating Patients With Recurrent Head and Neck Cancer
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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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California
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San Diego, California, Forenede Stater, 92121
- Sidney Kimmel Cancer Center
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Colorado
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Denver, Colorado, Forenede Stater, 80262
- University of Colorado Cancer Center
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Connecticut
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Farmington, Connecticut, Forenede Stater, 06032
- University of Connecticut School of Medicine
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Clinical Sciences Building
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
- University of Iowa Hospitals and Clinics
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160-7357
- University of Kansas Medical Center
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70112
- Tulane University School of Medicine
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Maryland
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Baltimore, Maryland, Forenede Stater, 21201
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
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New York
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Bronx, New York, Forenede Stater, 10461
- Albert Einstein Comprehensive Cancer Center
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Texas
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Dallas, Texas, Forenede Stater, 75235-9154
- Simmons Cancer Center - Dallas
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Lyndah Dreiling, MD, Aventis Pharmaceuticals
Datoer for undersøgelser
Studer store datoer
Studiestart
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- tilbagevendende metastatisk planehalskræft med okkult primær
- tilbagevendende pladecellekarcinom i læben og mundhulen
- tilbagevendende pladecellekarcinom i oropharynx
- tilbagevendende pladecellekarcinom i nasopharynx
- tilbagevendende pladecellekarcinom i hypopharynx
- tilbagevendende pladecellekarcinom i strubehovedet
- tilbagevendende pladecellekarcinom i paranasale sinus og næsehulen
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CDR0000066148
- AVENTIS-T-202
- MCC-11653
- RP-T-202
- NCI-V98-1394
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Kliniske forsøg med Ad5CMV-p53-gen
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Eastern Cooperative Oncology GroupNational Cancer Institute (NCI)AfsluttetLungekræftForenede Stater
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National Cancer Institute (NCI)AfsluttetTilbagevendende blærekræft | Stadie III blærekræft | Stadie IV blærekræft | Overgangscellekarcinom i blæren | Stadie I blærekræft | Stadie II blærekræftForenede Stater
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National Cancer Institute (NCI)Afsluttet
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University of Texas Southwestern Medical CenterNational Cancer Institute (NCI)AfsluttetLivmoderhalskræft | Peritoneal hulrumskræftForenede Stater
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National Cancer Institute (NCI)AfsluttetKræft i læbe og mundhule | Orofaryngeal cancer | Tungekræft | Stadie 0 Læbe- og mundhulekræft | Fase 0 Orofaryngeal cancerForenede Stater
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Eastern Cooperative Oncology GroupNational Cancer Institute (NCI)AfsluttetLungekræftForenede Stater
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Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI)AfsluttetTumorer i hjernen og centralnervesystemetForenede Stater
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National Cancer Institute (NCI)Afsluttet
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National Cancer Institute (NCI)Afsluttet
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Southwest Oncology GroupNational Cancer Institute (NCI)AfsluttetHoved- og halskræftForenede Stater