Imiquimod Cream in Treating Patients With Basal Cell Skin Cancer
Double-Blind, Vehicle-Controlled Study to Evaluate Apoptosis in Basal Cell Carcinoma Treated With Aldara™ (Imiquimod) Cream, 5% Applied Once or Twice a Day
RATIONALE: Biological therapies, such as imiquimod cream, work in different ways to stimulate the immune system and stop tumor cells from growing.
PURPOSE: This randomized phase I trial is studying how well imiquimod cream works in treating patients with basal cell skin cancer.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
OBJECTIVES:
Primary
- Compare levels of apoptosis in patients with basal cell skin cancer treated with vs without imiquimod 5% cream.
Secondary
- Compare levels of apoptosis in patients treated with this drug on two different administration schedules.
OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel-group study.
Patients undergo fine needle aspiration and punch biopsies of the target lesion. Patients are then randomized to 1 of 8 treatment arms and begin therapy within 30 days after biopsy.
- Arm I: Patients apply topical imiquimod to the target lesion once every 12 hours on days 1 and 2 for a total of 4 doses.
- Arm II: Patients apply topical placebo to the target lesion once every 12 hours on days 1 and 2 for a total of 4 doses.
- Arm III: Patients apply topical imiquimod to the target lesion once every 24 hours on days 1-4 for a total of 4 doses.
- Arm IV: Patients apply topical placebo to the target lesion once every 24 hours on days 1-4 for a total of 4 doses.
- Arm V: Patients apply topical imiquimod to the target lesion once every 12 hours on days 1-4 for a total of 8 doses.
- Arm VI: Patients apply topical placebo to the target lesion once every 12 hours on days 1-4 for a total of 8 doses.
- Arm VII: Patients apply topical imiquimod to the target lesion once every 24 hours on days 1-8 for a total of 8 doses.
- Arm VIII: Patients apply topical placebo to the target lesion every 24 hours on days 1-8 for a total of 8 doses.
All patients undergo excision of the target tumor within 18-30 hours after the last topical treatment.
Patients are followed at 7-14 days.
PROJECTED ACCRUAL: A total of 48 patients (8 per treatment arm and 4 per placebo arm) will be accrued for this study.
Tipo di studio
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Maryland
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Bethesda, Maryland, Stati Uniti, 20892-1182
- NIH - Warren Grant Magnuson Clinical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
DISEASE CHARACTERISTICS:
Histologically confirmed basal cell skin cancer
- Superficial or nodular disease
- No aggressive disease
At least 1 lesion at least 7 mm in diameter that meets the following criteria:
- Primary tumor (no recurrent or previously treated disease)
- Located on the scalp, face (including ears), trunk, or proximal extremities
- Qualifies for surgical excision as primary therapy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Cardiovascular
- No evidence of a clinically significant or unstable medical condition that would adversely affect blood circulation
Other
- No dermatological disease (e.g., psoriasis or eczema) at the treatment site that may be exacerbated by treatment with imiquimod or interfere with examination
- No febrile viral infection within the past 4 weeks
- No evidence of a clinically significant or unstable medical condition that would adversely affect immune function
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 4 weeks since prior interferon, interferon inducers, or immunomodulators
- No concurrent interferon, interferon inducers, or immunomodulators
Chemotherapy
- More than 6 months since prior anticancer chemotherapy
- No concurrent anticancer chemotherapy
Endocrine therapy
- More than 4 weeks since prior oral or inhaled (more than 600 mcg/day for fluticasone or equivalent) corticosteroids
- More than 4 weeks since prior topical steroids to the target tumor
- Concurrent topical steroids in non-target areas are allowed provided amount used is ≤ 2 g of fluorinated steroids daily for > 1 week or 6 g of beclomethasone for > 1 week
- No concurrent oral or inhaled corticosteroids
Radiotherapy
- Not specified
Surgery
- More than 4 months since prior biopsy
Other
- More than 4 weeks since prior immunosuppressive therapies
- More than 4 weeks since prior cytotoxic or investigational drugs
- No concurrent immunosuppressive therapies
- No other concurrent cytotoxic or investigational drugs
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Mascheramento: Doppio
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Francesco M. Marincola, MD, NIH - Warren Grant Magnuson Clinical Center
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Inizio studio
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CDR0000355151
- NCI-02-CC-0289
- 3M-1454-IMIQ
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