Advertisement

Topics

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

2014-08-27 03:55:29 | BioPortfolio

Summary

RATIONALE: 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.

PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in preventing cervical cancer in patients who have cervical intraepithelial neoplasia.

Description

OBJECTIVES:

Primary

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

- Determine the toxicity of this drug in these patients.

Secondary

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

- 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.

Study Design

Allocation: Randomized, Control: Active Control, Primary Purpose: Prevention

Conditions

Cervical Cancer

Intervention

HspE7

Location

Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham
Alabama
United States
35294

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:29-0400

Clinical Trials [936 Associated Clinical Trials listed on BioPortfolio]

Safety Study to Test the Safety of HspE7 and Poly-ICLC Given in Patients With Cervical Intraepithelial Neoplasia

The purpose of this study is to determine the safety and tolerability of HspE7 and Poly-ICLC when given together

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

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 developmen...

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

RATIONALE: 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 canc...

Promoting Cervical Cancer Screening for Emergency Department Patients

The purpose of this study is to learn methods to encourage women to get recommended cervical cancer screening. Cervical cancer screening is an important part of cervical cancer prevention....

The Kilimanjaro Cervical Screening Project

Although highly curable, cervical cancer kills thousands of women in developing countries annually. The investigators will pilot a project to improve detection of cervical cancer in Kilima...

PubMed Articles [14221 Associated PubMed Articles listed on BioPortfolio]

A Cross-Sectional Review of Cervical Cancer Messages on Twitter During Cervical Cancer Awareness Month.

The objectives of this study were to quantify personal stories about cervical cancer and to determine the proportion and sentiment (positive vs negative) of messages ("tweets") that discussed cervical...

Factors associated with cervical precancerous lesions among women screened for cervical cancer in Addis Ababa, Ethiopia: A case control study.

Cervical cancer is the second most prevalent cancer among women in the developing countries including Ethiopia. Precancerous lesions can be developed and risk to the development of cervical cancer ove...

Medical costs for the treatment of cervical cancer at central hospitals in Vietnam.

Cervical cancer remains the second most common cancer amongst female aged 15 to 44 years old in Vietnam. We estimated medical costs for the treatment of cervical cancer patients. We employed the stan...

Screening for cervical cancer in imprisoned women in Brazil.

Incarcerated women are more vulnerable to developing cervical cancer than women in general; therefore, screening and intervention programs must be included in their healthcare provision. We therefore ...

The Ideal Strategy for Cervical Cancer Screening in Japan: Result from the Fukui Cervical Cancer Screening Study.

The aims of the Fukui Cervical Cancer Screening (FCCS) study are to determine the frequency of women with high-risk HPV (hrHPV), whether HPV16 or HPV18 (HPV16/18), in the Japanese cancer screening pop...

Medical and Biotech [MESH] Definitions

Morphological abnormalities of the cervical EPITHELIUM, usually revealed in PAP SMEAR, which do not meet the criteria for squamous CERVICAL INTRAEPITHELIAL NEOPLASIA or SQUAMOUS CELL CARCINOMAS of the CERVIX . It may be a sign of infection with certain types of human papillomavirus (HPV).or sign of a benign (not cancer) growth, such as a cyst or polyp or, in menopausal women, of low hormone levels. More testing, such as HPV test, may be needed.

A network of nerve fibers originating in the upper four cervical spinal cord segments. The cervical plexus distributes cutaneous nerves to parts of the neck, shoulders, and back of the head, and motor fibers to muscles of the cervical spinal column, infrahyoid muscles, and the diaphragm.

A parameter usually used in PRENATAL ULTRASONOGRAPHY to measure the length of the uterine neck (CERVIX UTERI). Cervical length or its shortening is used to identify and prevent early cervical opening and PRETERM BIRTH.

Soft tissue tumors or cancer arising from the mucosal surfaces of the LIP; oral cavity; PHARYNX; LARYNX; and cervical esophagus. Other sites included are the NOSE and PARANASAL SINUSES; SALIVARY GLANDS; THYROID GLAND and PARATHYROID GLANDS; and MELANOMA and non-melanoma skin cancers of the head and neck. (from Holland et al., Cancer Medicine, 4th ed, p1651)

Tumors or cancer of the UTERINE CERVIX.

More From BioPortfolio on "Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Cervical Cancer
Cervical cancer is a malignant neoplasm of the cervix uteri or cervical area. Symptoms include vaginal bleeding, but may not present until later stages of the cancer. Cervical cancer can be treated using surgery (including local excision) in early stages...

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...


Searches Linking to this Trial