Infections

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Rare Diseases

Uterine Cervical Neoplasms

Communicable Diseases

Virus Diseases

Squamous Intraepithelial Lesions of the Cervix

Atypical Squamous Cells of the Cervix

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Uterine Cervical Dysplasia

Precancerous Conditions

Cervical Intraepithelial Neoplasia

All Drugs and Chemicals

Vaccines

Immunologic Factors

Patients receive SGN-00101 vaccine SC on day 1 of weeks 1, 4, and 8 for a maximum of 3 injections in the absence of unacceptable toxicity or the development of an invasive malignancy or serious illness.

Patients receive placebo vaccine SC on day 1 of weeks 1, 4, and 8 for a maximum of 3 injections in the absence of unacceptable toxicity or the development of an invasive malignancy or serious illness.

HspE7

placebo

laboratory biomarker analysis

Frank Meyskens

This randomized phase II trial is studying how well SGN-00101 vaccine works compared to a placebo in treating human papillomavirus and preventing cervical cancer in patients with abnormal cervical cells. Vaccines, such as SGN-00101, may make the body build an immune response to kill human papillomavirus and abnormal cervical cells and may be effective in preventing cervical cancer

PRIMARY OBJECTIVES:

I. Compare the effectiveness of SGN-00101 vaccine vs placebo in reducing the human papillomavirus (HPV)-16 viral load in patients with atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesions (LSIL) of the cervix with persistent HPV-16 infection who are at increased risk for developing a high-grade squamous intraepithelial lesion or invasive cervical cancer.

II. Compare the natural history of HPV-16 viral load in patients treated with these regimens.

III. Compare the effect of HPV-16 variants on viral load response in patients treated with these regimens.

IV. Compare the relative effectiveness of these regimens on the regression of cervical cellular atypias (based on Pap test results), in terms of the regression of cytologic findings of LSIL and ASCUS to normal findings and resolution or regression of colposcopically defined cervicovaginal lesions, in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive SGN-00101 vaccine subcutaneously (SC) on day 1 of weeks 1, 4, and 8 for a maximum of 3 injections in the absence of unacceptable toxicity or the development of an invasive malignancy or serious illness.

ARM II: Patients receive placebo vaccine SC on day 1 of weeks 1, 4, and 8 for a maximum of 3 injections in the absence of unacceptable toxicity or the development of an invasive malignancy or serious illness.

Patients are followed at 12, 24, and 52 weeks after the last vaccination.

SGN-00101 Vaccine in Treating Human Papillomavirus in Patients Who Have Abnormal Cervical Cells

An Exploratory Study to Evaluate the Effect of HPV 16 Vaccine on the Reduction of Viral Load in HPV 16 Positive Women With Persistent Viral Infection, But Low Grade Disease (ASCUS/LSIL)

Following the univariate modeling, multivariate logistic regression models will be constructed by adding the demographic factors, baseline viral load, and type of cellular atypia to the model. The univariate logistic regression model for infection resolution is equivalent to a chi-square test.

A repeated measures version of the zero-inflated log-normal model will be constructed.

The analysis for this will employ logistic regression models. A multivariate logistic regression model will be constructed. . A two group continuity corrected chi squared test with a 0.050 two-sided significance level will be used.

National Cancer Institute (NCI)

Immune System Diseases

Digestive System Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

HIV Seropositivity

Anus Neoplasms

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Anal Cancer

Patients receive SGN-00101 subcutaneously once on weeks 0, 4, and 8. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 5-6 patients receive escalating doses of SGN-00101 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experience dose-limiting toxicity.

Joel Palefsky, MD

Phase I/II trial to study the effectiveness of SGN-00101 in preventing anal cancer in HIV-positive patients who have high-grade anal neoplasia. Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. SGN-00101 may be effective in preventing anal cancer.

OBJECTIVES:

I. Determine the safety and maximum tolerated dose of SGN-00101 in HIV-positive patients with high-grade anal squamous intraepithelial lesions.

II. Determine clinical response and histologic/cytologic regression in patients treated with this drug.

III. Determine immune response in patients treated with this drug. IV. Determine the effect of this drug on HIV viral load and CD4 level in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive SGN-00101 subcutaneously once on weeks 0, 4, and 8. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 5-6 patients receive escalating doses of SGN-00101 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experience dose-limiting toxicity.

Patients are followed at 1, 4, and 10 months.

SGN-00101 in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia

A Phase I/II Trial of SGN-00101 in the Treatment of High-Grade Anal Intraepithelial Neoplasia (AIN) in HIV-Positive Individuals

Papillomavirus Infections

Papilloma

Carcinoma

Carcinoma in Situ

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

DNA Virus Infections

Tumor Virus Infections

Disease Attributes

Patients receive SGN-00101 subcutaneously once on weeks 1, 4, and 8 in the absence of disease progression. At week 15, all patients undergo large loop excision of the transformation zone under colposcopy.

Patients receive standard care. At week 15, all patients undergo large loop excision of the transformation zone under colposcopy.

therapeutic conventional surgery

Cornelia Trimble

Vaccines made from antigens may make the body build an immune response to kill abnormal cervical cells and may be effective in preventing cervical cancer. Randomized phase II trial to study the effectiveness of vaccine therapy in preventing cervical cancer in patients who have cervical intraepithelial neoplasia

PRIMARY OBJECTIVES:

I. Determine the efficacy of SGN-00101, in terms of complete histologic regression, in patients with grade III cervical intraepithelial neoplasia.

II. Determine the toxicity of this drug in these patients.

SECONDARY OBJECTIVES:

I. Determine change in lesion size in these patients after treatment with this drug.

II. Compare histologic response before and after treatment with this drug in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive SGN-00101 subcutaneously once on weeks 1, 4, and 8 in the absence of disease progression.

Arm II: Patients receive standard care.

At week 15, all patients undergo large loop excision of the transformation zone under colposcopy.

Patients are followed at 19 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 28-84 patients (14-42 per treatment arm) will be accrued for this study within 12-48 months.

Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia

Phase II Evaluation Of SGN-00101 (HSP-E7) Fusion Protein In Women With Cervical Intraepithelial Neoplasia 3, CIN 3

Fisher's exact test (and if feasible, Chi-Square test) will be conducted to see if the probability of responding in the investigational arm is significantly different from the controls actively accrued to this study. The conditional distribution used in Fisher's exact test will be used to calculate a 90% confidence interval for the odds ratio of observing a response in the investigational arm to the control arm.

Immunomodulating Agents

BCG Vaccine

3 monthly subcutaneous vaccinations with 500 microg of HspE7 followed by monthly colposcopic follow-up for 1 month; followed by LEEP or cone biopsy

3 monthly subcutaneous vaccinations with 500 microg of HspE7 followed by monthly colposcopic follow-up for 2 months; followed by LEEP or cone biopsy

500 micrograms of SGN-00101 (HspE7, Nventa, San Diego, CA) is a novel therapeutic vaccine consisting of a fusion protein containing an M. bovis BCG heat shock protein (Hsp65) covalently linked to the entire sequence of HPV 16 E7.

Carolyn D. Runowicz, MD

Mark H. Einstein, MD, MS

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer or to treat early cancer. SGN-00101 may be effective in preventing the development of cervical cancer in patients who have cervical intraepithelial neoplasia.

PURPOSE: This phase II trial is studying how well SGN-00101 immunotherapy works in preventing cervical cancer in patients with grade III cervical intraepithelial neoplasia.

OBJECTIVES:

Primary

* Determine the rate of regression at 4-7 months in patients with grade III cervical intraepithelial neoplasia (CIN III) treated with SGN-00101 immunotherapy.
* Compare the rate of regression at 4-7 months with expected outcome in patients immunized with this vaccine.
* Determine the toxic effects and recovery from possible toxic effects of this vaccine in these patients.

Secondary

* Determine induction of cell-mediated immune responses against human papillomavirus (HPV) E7 peptides before and after treatment in patients immunized with this vaccine
* Correlate regression of disease with enhanced immunologic responses in patients immunized with this vaccine.
* Correlate seropositivity of HPV-16 virus-like particles (VLP16) with vaccine-induced regression of CIN III in patients immunized with this vaccine.
* Determine the efficacy of this vaccine in patients whose CIN III is associated with HPV-16 infection vs other HPV types.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 treatment groups.

All patients receive SGN-00101 subcutaneously once monthly on months 1-3 (for a total of 3 vaccinations) in the absence of disease progression or unacceptable toxicity.

* Group 1: Four months after the first vaccination, patients undergo therapeutic and diagnostic loop electrosurgical excision procedure (LEEP) or core biopsy.
* Group 2: Six months after the first vaccination, patients undergo therapeutic and diagnostic LEEP or core biopsy.

Patients in group 1 are followed at 12 months and patients in group 2 are followed at 14 months after the first vaccination.

PROJECTED ACCRUAL: A total of 66 patients (36 for group 1 and 30 for group 2) will be accrued for this study.

SGN-00101 Immunotherapy in Treating Patients With Grade III Cervical Intraepithelial Neoplasia

SGN-00101 (HspE7) Immunotherapy Of CIN III

Albert Einstein College of Medicine

Kristin A. Keefe, MD

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of or treat early cancer. SGN-00101 may be effective in preventing the development of cervical cancer in patients with cervical intraepithelial neoplasia.

PURPOSE: This randomized phase II trial is studying how well SGN-00101 works in preventing cervical cancer in patients with cervical intraepithelial neoplasia and human papillomavirus.

OBJECTIVES:

* Compare the efficacy of SGN-00101 vs placebo in patients with grade II or III cervical intraepithelial neoplasia.
* Correlate clinical response, as defined by histologic demonstration of lesion regression, with potential surrogate markers of vaccine efficacy (e.g., spectroscopic changes in the epithelium, development of human papilloma virus (HPV)-specific mucosal and systemic T-cell responses, and levels of HPV-specific antibody in cervical secretions), in patients treated with this drug.

OUTLINE: This is a randomized, double-blind study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive SGN-00101 subcutaneously (SC) once a month for 3 consecutive months in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive placebo SC as in arm I. Patients are followed monthly for 3 months after the last injection and then undergo large loop excision of the transformation zone under colposcopy at the fourth month. Patients with disease progression undergo immediate large loop excision.

PROJECTED ACCRUAL: A maximum of 80 patients (40 per treatment arm) will be accrued for this study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
SGN-00101 Vaccine in Treating Human Papillomavirus in Patients Who Have Abnormal Cervical Cells	NCT00091130	Atypical Squamo... Cervical Cancer High-grade Squa... Low-grade Squam...	HspE7 placebo laboratory biom...	18 Years - 50 Years	National Cancer Institute (NCI)
SGN-00101 in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia	NCT00052897	Anal Cancer	HspE7	18 Years -	National Cancer Institute (NCI)
Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia	NCT00054041	Cervical Cancer Cervical Intrae... Human Papilloma...	HspE7 therapeutic con... laboratory biom...	17 Years -	National Cancer Institute (NCI)
SGN-00101 Immunotherapy in Treating Patients With Grade III Cervical Intraepithelial Neoplasia	NCT00075569	Cervical Cancer Precancerous Co...	HspE7	18 Years - 120 Years	Albert Einstein College of Medicine
Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia	NCT00054041	Cervical Cancer Cervical Intrae... Human Papilloma...	HspE7 therapeutic con... laboratory biom...	17 Years -	National Cancer Institute (NCI)
SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia	NCT00060099	Precancerous Co...	HspE7	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for hspe7

Every month we try and update this database with for hspe7 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hspe7

Every month we try and update this database with for hspe7 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hspe7 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.