cytosine and Carcinoma in Situ studies

Carcinoma in Situ: A lesion with cytological characteristics associated with invasive carcinoma but the tumor cells are confined to the epithelium of origin, without invasion of the basement membrane.

Research Excerpts

Excerpt	Relevance	Reference
" The study was designed to compare the effects of oral bropirimine with intravesical BCG, the current standard treatment in patients with newly diagnosed bladder carcinoma in situ (CIS)."	9.09	Results of a European comparative randomized study comparing oral bropirimine versus intravesical BCG treatment in BCG-naive patients with carcinoma in situ of the urinary bladder. European Bropirimine Study Group. ( Boeminghaus, FP; Debruyne, FM; Fittipaldo, A; Hall, RR; König, M; Riggi, M; Schulman, CC; Witjes, WP; Zurlo, M, 1999)
"Bropirimine is an orally administered immunostimulant that has been shown to have activity against carcinoma in situ (CIS) of the bladder."	9.08	Oral bropirimine immunotherapy of carcinoma in situ of the bladder: results of a phase II trial. ( Crawford, ED; Flanigan, RC; Graham, SD; Grossman, HB; Lamm, DL; Lowe, BA; Moon, TD; Morganroth, J; Peabody, JO; Sarosdy, MF; Schellhammer, PF; See, WA, 1996)
"Bropirimine has been shown to be effective in treating approximately 50% of patients with carcinoma in situ (CIS) of the bladder in recent clinical trials."	9.08	Bropirimine immunotherapy of upper urinary tract carcinoma in situ. ( Benson, MC; Carroll, PR; Hudson, MA; Koch, MO; Lamm, DL; Lerner, SP; Moon, TD; Pisters, LL; Sarosdy, MF; Schellhammer, PF, 1996)
"Bropirimine is an oral immunomodulator that has demonstrated anticancer activity in transitional cell carcinoma in situ (CIS) in both the bladder and upper urinary tract."	9.08	Oral bropirimine immunotherapy of bladder carcinoma in situ after prior intravesical bacille Calmette-Guérin. ( Belldegrun, A; Benson, MC; Bihrle, W; Carroll, PR; Ellis, WJ; Hudson, MA; Manyak, MJ; Sagalowsky, AI; Sarosdy, MF; Sharkey, FE, 1998)
"Bropirimine has been shown to have activity against carcinoma in situ (CIS) of the bladder in a previous phase-I trial."	8.79	A review of clinical studies of bropirimine immunotherapy of carcinoma in situ of the bladder and upper urinary tract. ( Sarosdy, MF, 1997)
" The study was designed to compare the effects of oral bropirimine with intravesical BCG, the current standard treatment in patients with newly diagnosed bladder carcinoma in situ (CIS)."	5.09	Results of a European comparative randomized study comparing oral bropirimine versus intravesical BCG treatment in BCG-naive patients with carcinoma in situ of the urinary bladder. European Bropirimine Study Group. ( Boeminghaus, FP; Debruyne, FM; Fittipaldo, A; Hall, RR; König, M; Riggi, M; Schulman, CC; Witjes, WP; Zurlo, M, 1999)
"A follow-up investigation was conducted on a Late Phase II clinical study of bropirimine for carcinoma in situ (CIS) of the bladder."	5.09	[Late phase II clinical study for bropirimine (U-54461S) in situ carcinoma of the bladder: follow-up investigation. Bropirimine Study Group]. ( Akaza, H; Kagawa, S; Kotake, T; Machida, T; Okajima, E; Shimazaki, J; Tashiro, K, 1999)
"Bropirimine is an orally administered immunostimulant that has been shown to have activity against carcinoma in situ (CIS) of the bladder."	5.08	Oral bropirimine immunotherapy of carcinoma in situ of the bladder: results of a phase II trial. ( Crawford, ED; Flanigan, RC; Graham, SD; Grossman, HB; Lamm, DL; Lowe, BA; Moon, TD; Morganroth, J; Peabody, JO; Sarosdy, MF; Schellhammer, PF; See, WA, 1996)
"Bropirimine has been shown to be effective in treating approximately 50% of patients with carcinoma in situ (CIS) of the bladder in recent clinical trials."	5.08	Bropirimine immunotherapy of upper urinary tract carcinoma in situ. ( Benson, MC; Carroll, PR; Hudson, MA; Koch, MO; Lamm, DL; Lerner, SP; Moon, TD; Pisters, LL; Sarosdy, MF; Schellhammer, PF, 1996)
"Bropirimine is an oral immunomodulator that has demonstrated anticancer activity in transitional cell carcinoma in situ (CIS) in both the bladder and upper urinary tract."	5.08	Oral bropirimine immunotherapy of bladder carcinoma in situ after prior intravesical bacille Calmette-Guérin. ( Belldegrun, A; Benson, MC; Bihrle, W; Carroll, PR; Ellis, WJ; Hudson, MA; Manyak, MJ; Sagalowsky, AI; Sarosdy, MF; Sharkey, FE, 1998)
"Bropirimine has been shown to have activity against carcinoma in situ (CIS) of the bladder in a previous phase-I trial."	4.79	A review of clinical studies of bropirimine immunotherapy of carcinoma in situ of the bladder and upper urinary tract. ( Sarosdy, MF, 1997)
" Secondary outcomes were toxic effects (to assess safety) and adherence to treatment (to assess feasibility)."	2.79	Activity, safety, and feasibility of cidofovir and imiquimod for treatment of vulval intraepithelial neoplasia (RT³VIN): a multicentre, open-label, randomised, phase 2 trial. ( Dutton, P; Fiander, A; Griffiths, G; Hibbitts, S; Hurt, CN; Jones, S; Madden, T; Man, S; Naik, R; Nordin, AJ; Powell, N; Tristram, A, 2014)
" Treatment was well tolerated with most common adverse events being mild to moderate affecting lesional skin: pain/burning/irritation (25 patients) and ulceration (13 patients)."	2.78	Safety and efficacy of topical cidofovir to treat high-grade perianal and vulvar intraepithelial neoplasia in HIV-positive men and women. ( Aboulafia, D; Berry, JM; Da Costa, M; Darragh, TM; Einstein, MH; Goldstone, SE; Jay, N; Lee, JY; Palefsky, JM; Panther, L; Stier, EA; Wilkin, T, 2013)

Research

Studies (25)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

Correlation of Clinical Regression of Perianal HSIL With Clearance of HPV DNA

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	11 (44.00)	18.2507
2000's	5 (20.00)	29.6817
2010's	9 (36.00)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Ip, MH	1
Coroneo, MT	1
Jones, SEF	1
Hibbitts, S	2
Hurt, CN	2
Bryant, D	1
Fiander, AN	1
Powell, N	2
Tristram, AJ	1
Mahner, S	1
Wölber, L	1
Tristram, A	2
Madden, T	1
Man, S	1
Dutton, P	1
Jones, S	1
Nordin, AJ	1
Naik, R	1
Fiander, A	2
Griffiths, G	1
Pepas, L	2
Kaushik, S	2
Nordin, A	2
Bryant, A	2
Lawrie, TA	2
Chakrabarti, M	1
Sendagorta, E	1
Bernardino, JI	1
Álvarez-Gallego, M	1
Feíto, M	1
Feltes, R	1
Beato, MJ	1
Pérez-Molina, JA	1
Yllescas, M	1
Díaz-Almirón, M	1
Arribas, JR	1
González-García, J	1
Herranz, P	1
Stier, EA	1
Goldstone, SE	1
Einstein, MH	1
Jay, N	1
Berry, JM	1
Wilkin, T	1
Lee, JY	1
Darragh, TM	1
Da Costa, M	1
Panther, L	1
Aboulafia, D	1
Palefsky, JM	1
Nathan, M	1
Toro, JR	1
Sanchez, S	1
Turiansky, G	1
Blauvelt, A	1
Kassouf, W	1
Kamat, AM	1
Sarosdy, MF	6
Lowe, BA	1
Schellhammer, PF	2
Lamm, DL	3
Graham, SD	1
Grossman, HB	1
See, WA	1
Peabody, JO	1
Moon, TD	3
Flanigan, RC	2
Crawford, ED	2
Morganroth, J	1
Pisters, LL	1
Carroll, PR	2
Benson, MC	2
Hudson, MA	2
Lerner, SP	1
Koch, MO	1
Akaza, H	2
Shimazaki, J	2
Tashiro, K	2
Kotake, T	2
Okajima, E	2
Kagawa, S	2
Machida, T	2
Witjes, JA	1
Manyak, MJ	1
Sagalowsky, AI	1
Belldegrun, A	1
Bihrle, W	1
Ellis, WJ	1
Sharkey, FE	1
Majeed, GS	1
Glew, S	1
Bidwell, J	1
Witjes, WP	1
König, M	1
Boeminghaus, FP	1
Hall, RR	1
Schulman, CC	1
Zurlo, M	1
Fittipaldo, A	1
Riggi, M	1
Debruyne, FM	1
Descamps, V	1
Duval, X	1
Grossin, M	1
Crickx, B	1
Leport, C	1
Koonsaeng, S	1
Verschraegen, C	1
Freedman, R	1
Bossens, M	1
Kudelka, A	1
Kavanagh, J	1
Sittisomwong, T	1
DeClercq, E	1
Snoeck, R	1
Williams, RD	1
Wilks, NE	1
Earhart, RH	1
Merritt, JA	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Prospective, With One Site, Open-label Not Controled Trial, for the Observation of Treatment With CIDOFOVIR 1%, 3 Nights Per Week, During 4 Weeks, of Anal Intraepithelial Neoplasia, High Level, in HIV+ Patients[NCT01946009]		20 participants (Actual)	Interventional	2013-09-30	Completed
Phase IIA Trial of 1% Topical Cidofovir for Treatment of High-Grade Perianal Squamous Intraepithelial Lesions in HIV-Infected Men and Women[NCT00550589]	Phase 2	33 participants (Actual)	Interventional	2007-09-30	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Number of patients who cleared HPV among those who had a complete or partial response (NCT00550589)
Timeframe: 6 weeks after treatment discontinuation

Human Papilloma Virus (HPV) DNA Type in Perianal HSIL and Normal Perianal Tissue

Intervention	participants (Number)
Cidofovir	2

Number of patients with HPV16 at baseline in perianal HSIL and normal perianal tissue (NCT00550589)
Timeframe: Baseline

Identification of HPV-DNA Types Present in the Anus

Intervention	participants (Number)
Cidofovir	16

Number of patients with HPV16 type present in the anus from anal swab or cytobrush at baseline (NCT00550589)
Timeframe: Baseline

Proportion of Patients With Regression of Perianal High-grade Squamous Intraepithelial Lesions (HSIL)

Safety and Tolerability of Topical Cidofovir as Assessed by NCI CTCAE v3.0

Intervention	participants (Number)
Cidofovir	14

Intervention	proportion of participants (Number)
Cidofovir	0.515

Number of study patients who had a serious adverse event (NCT00550589)
Timeframe: Every 2 weeks on study, 6 weeks after treatment discontinuation

Article	Year
Medical interventions for high-grade vulval intraepithelial neoplasia. The Cochrane database of systematic reviews, 2015, Aug-18, Issue:8 Topics: Administration, Topical; Adult; Aminoquinolines; Anticarcinogenic Agents; Antineoplastic Agents; Car	2015
Medical and surgical interventions for the treatment of usual-type vulval intraepithelial neoplasia. The Cochrane database of systematic reviews, 2016, Jan-05, Issue:1 Topics: Adult; Aminoquinolines; Antineoplastic Agents; Carcinoma in Situ; Cidofovir; Cytosine; Disease Progr	2016
Topical cidofovir for the treatment of dermatologic conditions: verruca, condyloma, intraepithelial neoplasia, herpes simplex and its potential use in smallpox. Dermatologic clinics, 2003, Volume: 21, Issue:2 Topics: Administration, Cutaneous; Administration, Topical; Antiviral Agents; Carcinoma in Situ; Carcinoma,	2003
Current state of immunotherapy for bladder cancer. Expert review of anticancer therapy, 2004, Volume: 4, Issue:6 Topics: Adjuvants, Immunologic; Antineoplastic Agents; BCG Vaccine; Carcinoma in Situ; Cytosine; Drug Admini	2004
Treatment of carcinoma in situ of the urinary bladder with bropirimine. European urology, 1997, Volume: 31 Suppl 1 Topics: Adjuvants, Immunologic; Antineoplastic Agents; Carcinoma in Situ; Clinical Trials as Topic; Cytosine	1997
A review of clinical studies of bropirimine immunotherapy of carcinoma in situ of the bladder and upper urinary tract. European urology, 1997, Volume: 31 Suppl 1 Topics: Adjuvants, Immunologic; Antineoplastic Agents; Carcinoma in Situ; Clinical Trials as Topic; Cytosine	1997

Article	Year
Activity, safety, and feasibility of cidofovir and imiquimod for treatment of vulval intraepithelial neoplasia (RT³VIN): a multicentre, open-label, randomised, phase 2 trial. The Lancet. Oncology, 2014, Volume: 15, Issue:12 Topics: Adult; Aminoquinolines; Antineoplastic Combined Chemotherapy Protocols; Carcinoma in Situ; Cidofovir	2014
Topical cidofovir to treat high-grade anal intraepithelial neoplasia in HIV-infected patients: a pilot clinical trial. AIDS (London, England), 2016, Jan-02, Volume: 30, Issue:1 Topics: Administration, Topical; Adult; Antiviral Agents; Anus Neoplasms; Biopsy; Carcinoma in Situ; Cidofov	2016
Safety and efficacy of topical cidofovir to treat high-grade perianal and vulvar intraepithelial neoplasia in HIV-positive men and women. AIDS (London, England), 2013, Feb-20, Volume: 27, Issue:4 Topics: Acquired Immunodeficiency Syndrome; Administration, Cutaneous; Adult; Aged; Antiviral Agents; Anus N	2013
Clinical responses to Cidofovir applied topically to women with high grade vulval intraepithelial neoplasia. Gynecologic oncology, 2005, Volume: 99, Issue:3 Topics: Administration, Topical; Adult; Aged; Antineoplastic Agents; Carcinoma in Situ; Cidofovir; Cytosine;	2005
Bropirimine in bladder cancer: clinical studies. Annals of the New York Academy of Sciences, 1993, Jun-23, Volume: 685 Topics: Antineoplastic Agents; BCG Vaccine; Carcinoma in Situ; Cytosine; Humans; Urinary Bladder Neoplasms	1993
Oral bropirimine immunotherapy of carcinoma in situ of the bladder: results of a phase II trial. Urology, 1996, Volume: 48, Issue:1 Topics: Adjuvants, Immunologic; Administration, Oral; Adult; Aged; Aged, 80 and over; Carcinoma in Situ; Cyt	1996
Bropirimine immunotherapy of upper urinary tract carcinoma in situ. Urology, 1996, Volume: 48, Issue:1 Topics: Adjuvants, Immunologic; Aged; Aged, 80 and over; Carcinoma in Situ; Cytosine; Female; Humans; Male;	1996
[Bropirimine (U-54461S) late phase II clinical study for carcinoma in situ of the bladder. Japan Bropirimine Study Group]. Gan to kagaku ryoho. Cancer & chemotherapy, 1997, Volume: 24, Issue:1 Topics: Administration, Oral; Anorexia; Antineoplastic Agents; Carcinoma in Situ; Cytosine; Drug Administrat	1997
Oral bropirimine immunotherapy of bladder carcinoma in situ after prior intravesical bacille Calmette-Guérin. Urology, 1998, Volume: 51, Issue:2 Topics: Adjuvants, Immunologic; Administration, Oral; BCG Vaccine; Carcinoma in Situ; Cytosine; Humans; Remi	1998
Results of a European comparative randomized study comparing oral bropirimine versus intravesical BCG treatment in BCG-naive patients with carcinoma in situ of the urinary bladder. European Bropirimine Study Group. European urology, 1999, Volume: 36, Issue:6 Topics: Adjuvants, Immunologic; Administration, Oral; BCG Vaccine; Carcinoma in Situ; Chi-Square Distributio	1999
[Late phase II clinical study for bropirimine (U-54461S) in situ carcinoma of the bladder: follow-up investigation. Bropirimine Study Group]. Gan to kagaku ryoho. Cancer & chemotherapy, 1999, Volume: 26, Issue:13 Topics: Administration, Intravesical; Administration, Oral; Antineoplastic Agents; BCG Vaccine; Carcinoma in	1999

Article	Year
Treatment of Previously Refractory Ocular Surface Squamous Neoplasia With Topical Cidofovir. JAMA ophthalmology, 2017, 05-01, Volume: 135, Issue:5 Topics: Administration, Ophthalmic; Aged; Carcinoma in Situ; Cidofovir; Conjunctival Neoplasms; Cytosine; Hu	2017
Human Papillomavirus DNA Methylation Predicts Response to Treatment Using Cidofovir and Imiquimod in Vulval Intraepithelial Neoplasia 3. Clinical cancer research : an official journal of the American Association for Cancer Research, 2017, Sep-15, Volume: 23, Issue:18 Topics: Aminoquinolines; Biomarkers; Carcinoma in Situ; Cidofovir; Cytosine; DNA Methylation; DNA, Viral; Dr	2017
Surgery or topical therapy for vulval intraepithelial neoplasia. The Lancet. Oncology, 2014, Volume: 15, Issue:12 Topics: Aminoquinolines; Carcinoma in Situ; Cidofovir; Cytosine; Female; Humans; Imiquimod; Organophosphonat	2014
Treatment of anal intraepithelial neoplasia: has it come of age? AIDS (London, England), 2013, Feb-20, Volume: 27, Issue:4 Topics: Antiviral Agents; Anus Neoplasms; Carcinoma in Situ; Cidofovir; Cytosine; Female; HIV Infections; Hu	2013
An association between LSIL and the high secretor phenotype of IL-1beta. Gynecologic oncology, 1999, Volume: 73, Issue:3 Topics: Adenocarcinoma; Carcinoma in Situ; Carcinoma, Squamous Cell; Cytosine; Female; Humans; Interleukin-1	1999
Topical cidofovir for bowenoid papulosis in an HIV-infected patient. The British journal of dermatology, 2001, Volume: 144, Issue:3 Topics: Adult; Antineoplastic Agents; Antiviral Agents; Anus Neoplasms; Carcinoma in Situ; Carcinoma, Squamo	2001
Successful treatment of recurrent vulvar intraepithelial neoplasia resistant to interferon and isotretinoin with cidofovir. Journal of medical virology, 2001, Volume: 64, Issue:2 Topics: Administration, Oral; Administration, Topical; Adult; Antineoplastic Agents; Carcinoma in Situ; Cido	2001
Phase 1 trial of oral bropirimine in superficial bladder cancer. The Journal of urology, 1992, Volume: 147, Issue:1 Topics: Administration, Oral; Antineoplastic Agents; Carcinoma in Situ; Carcinoma, Papillary; Carcinoma, Tra	1992

cytosine and Carcinoma in Situ