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Vulvar Cancer clinical trials

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NCT ID: NCT00851643 Completed - Cervical Cancer Clinical Trials

Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)

Start date: April 2006
Phase: Phase 1
Study type: Interventional

This study will examine the safety and tolerability of octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) vaccine formulated with amorphous aluminum hydroxysulfate (AAHS) and ISCOMATRIX™ (IMX). Reviews of safety and tolerability will be used to select the dose(s) of IMX for further studies of the octavalent HPV L1 VLP vaccine.

NCT ID: NCT00842452 Completed - Ovarian Cancer Clinical Trials

Topotecan in Treating Patients With Gynecologic Cancer That Cannot Be Removed by Surgery

Start date: February 2009
Phase: Phase 1
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects and best dose of topotecan in treating patients with gynecologic cancer that cannot be removed by surgery.

NCT ID: NCT00773071 Completed - Cervical Cancer Clinical Trials

Added-value of SPECT/CT in Patients Undergoing LM/SL for Gynecological Cancers

Start date: April 2008
Phase: N/A
Study type: Interventional

Nodal staging is a key-step in pre-treatment assessment of gynecological cancers. In recent years, lymphatic mapping and sentinel lymphadenectomy (LM/SL) as a minimally invasive pelvic lymph nodes staging has been successfully evaluated in women with early stage of vulvar cancer, cervical cancer, and endometrial cancer. Such a technique may offer several valuable advantages: a) it is readily applicable in clinical routine using a safe, inexpensive, and reproducible protocol; b) it may help to avoid the cost and the morbidity of unnecessary lymphadenectomy in the majority of cases with uninvolved sentinel lymph nodes; c) it has the potential to guide the surgeon to nodal regions that are not routinely dissected (i.e. pre-sacral, para-aortic nodes) and to identify micro-metastases that would have been ignored otherwise; d) it also offers the basis for sophisticated pathological analysis to detect sub-microscopic nodal metastases using either immunohistochemical or molecular biological techniques. So far, within the abdomen and the pelvis, the LM/SL technique alone is often blinded to the accurate localization of SLNs. The integration of computed tomography (CT) to single photon emission computed tomography (SPECT) devices in a single gantry (SPECT/CT) has allowed a significant gain in terms of diagnostic accuracy and anatomic precision; clinical examples include malignant melanoma, head and neck cancer, breast cancer, and bladder cancer. In a seminal series of 26 patients with cervical cancer (Zhang et al., 2006), SPECT/CT was recently found superior to conventional planar imaging for detection of SLN and accurate localization. A more recent study (Kushner al., 2007) has also highlighted the technical feasibility and the clinical added-value of a low-dose SPECT/CT in a series of 20 patients with early stage cervical cancer (IA2-IIA) who underwent LM/SL. In the light of the encouraging data from literature and our own preliminary clinical experience, we hypothesized that the use of LM/SL plus SPECT/CT may be of clinical interest in patients with gynecological cancers.

NCT ID: NCT00551187 Completed - Cervical Cancer Clinical Trials

A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED)

Start date: October 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate vaccine immunogenicity and how well the body tolerates V504 when given with Gardasil.

NCT ID: NCT00543543 Completed - Cervical Cancer Clinical Trials

Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)

Start date: September 24, 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the safety, efficacy, and immunogenicity of V503 in comparison to GARDASIL. The primary hypotheses tested in the study were 1) V503 administered to 16- to 26-year-old adolescents and young women is generally well-tolerated, 2) V503 reduces combined incidence of Human Papillomavirus (HPV) Type 31/33/45/52/58-related disease compared with GARDASIL, and 3) V503 induces non-inferior geometric mean titers for HPV Type 6/11/16/18 antibodies compared with GARDASIL.

NCT ID: NCT00520598 Completed - Cervical Cancer Clinical Trials

Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001)

Start date: October 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison to GARDASIL (TM)

NCT ID: NCT00504023 Completed - Vulvar Cancer Clinical Trials

Topical Imiquimod in Treating Patients With Recurrent Paget's Disease of the Vulva

Start date: April 2007
Phase: N/A
Study type: Interventional

RATIONALE: Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Applying topical imiquimod to the vulva may be an effective treatment for recurrent Paget's disease. PURPOSE: This clinical trial is studying how well topical imiquimod works in treating patients with recurrent Paget's disease of the vulva.

NCT ID: NCT00381888 Completed - Ovarian Cancer Clinical Trials

Fondaparinux in Preventing Blood Clots in Patients Undergoing Surgery for Gynecologic Cancer

Start date: January 2007
Phase: Phase 2
Study type: Interventional

RATIONALE: Fondaparinux may help prevent blood clots from forming in patients who are undergoing surgery for gynecologic cancer. PURPOSE: This phase II trial is studying how well fondaparinux works in preventing blood clots in patients undergoing surgery for gynecologic cancer.

NCT ID: NCT00315159 Completed - Vulvar Cancer Clinical Trials

Conservative Management With Isolated Sentinel Lymph Node Biopsy in Vulvar Cancer Patients.

Start date: August 2003
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate a less invasive procedure for the evaluation of the inguinal (groin) nodes in patients with a primary squamous cell carcinoma of the vulva. Each patient will undergo a sentinel lymph node dissection as well as resection of the primary tumor on the vulva. Patients who are determined to have sentinel nodes that are negative for metastatic disease will not receive a full groin dissection. Patients who have sentinel lymph nodes that contain metastasis will undergo a complete inguinal dissection. The study will evaluate the long-term outcomes in patients who receive only a sentinel lymph node dissection without a complete dissection. All patients entered onto the study will have a biopsy proven squamous cell carcinoma of the vulva. Each patient will be enrolled by a Gynecologic Oncologist practicing out of Women & Infants Hospital

NCT ID: NCT00287885 Completed - Ovarian Cancer Clinical Trials

Docetaxel in Treating Patients With Refractory or Recurrent Advanced Gynecologic Cancer

Start date: March 2004
Phase: Phase 1
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Docetaxel may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving daily doses of docetaxel may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel in treating patients with refractory or recurrent advanced gynecologic cancer.