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NCT ID: NCT01499160 Terminated - Breast Neoplasms Clinical Trials

Letrozole and Lapatinib Followed by Everolimus in Women With Advanced Breast Cancer

Start date: May 2012
Phase: Phase 2
Study type: Interventional

About a third of patients with breast cancer are usually treated by hormone pills called tamoxifen and aromatase inhibitors. Aromatase inhibitors are drugs that stop female hormone production. Female hormone or estrogen is an important hormone for the growth of breast cancer cells. Letrozole is one of the aromatase inhibitors that is approved by the FDA and has been used to treat breast cancer since 1997. However, hormone pills usually work for about 6-10 months in most patients. Later on, breast cancer will start to grow again. This condition when hormone pills or endocrine therapy no longer work is called "endocrine resistant" breast cancer. The scientists here at University of Maryland have discovered how these cancer cells can become resistant to hormone pills. In our laboratory tests, the investigators found that lapatinib and everolimus can reverse this resistance and make letrozole work again. However, it is not known if the drugs can reverse the resistance in humans. The purpose of this study is to find out whether the combination of letrozole, lapatinib, and everolimus is effective in women with breast cancer when hormone pills no longer work. Lapatinib is an anti-cancer drug that is already approved by the Food and Drug Administration (FDA). It is the standard of care for the treatment of a particular type of breast cancer called human epithelial growth factor receptor 2 (HER2)-positive breast cancer. HER2 is a protein involved in the growth of some cancer cells. This study will also include patients with HER2-negative breast cancer. This means that the cancer cells in these patients do not depend on the HER2 protein. The use of lapatinib in these patients is considered experimental. Everolimus is also an anti-cancer drug that is approved by the FDA for kidney cancer. Initial studies in mice and later studies in women with breast cancer have shown that everolimus may also slow the growth of breast cancer. The use of everolimus is experimental in this study.

NCT ID: NCT01498588 Terminated - Breast Cancer Clinical Trials

Trial of Eribulin Followed by Doxorubicin & Cyclophosphamide for Her2-negative, Locally Advanced Breast Cancer

Start date: November 2011
Phase: Phase 2
Study type: Interventional

Previous studies have shown that chemotherapy has the same effect on treating breast cancer whether you receive it before or after surgery. Receiving chemotherapy before surgery, rather than after surgery, may allow the patient to have less extensive surgery. The purpose of this study is to identify new treatment regimens with better response rates and to find out if the combination of eribulin followed by doxorubicin and cyclophosphamide can shrink the size of the patient's breast tumor and allow you to preserve your breast. Additionally, by receiving chemotherapy before surgery, the investigators will be able to determine if your cancer is responsive to chemotherapy.

NCT ID: NCT01494012 Terminated - Clinical trials for Recurrent Ovarian Epithelial Cancer

Phase I Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian Cancer

Start date: April 2012
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and the best dose of stereotactic body radiation therapy (SBRT) in treating patients with metastatic or recurrent ovarian cancer or primary peritoneal cancer. SBRT may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

NCT ID: NCT01479348 Terminated - Breast Neoplasms Clinical Trials

Imaging Study for FdCyd and THU Cancer Treatment

Start date: November 1, 2011
Phase: Early Phase 1
Study type: Interventional

Background: - The drugs FdCyd (also called 5-fluoro-2'-deoxycytidine) and THU (also called tetrahydrouridine) are being used in a cancer treatment study. Not a lot is known about how FdCyd works in the body. Researchers want to look at a modified form of FdCyd using imaging studies to see how the drug reacts with the cancer. This study is not a treatment study. It is open only to people who are already on the FdCyd and THU cancer treatment study. Objectives: - To study how FdCyd affects advanced cancer cells. Eligibility: - Participants in National Cancer Institute study 09-C-0214. Design: - Participants will have two imaging studies, one before starting FdCyd and THU treatment and one after starting treatment. - Participants will have the modified FdCyd, known as F-18 FdCyd, with a dose of THU. The doses will be followed by two imaging study scans and frequent blood samples. - This procedure will be repeated at a later date, during the FdCyd and THU treatment period. - Treatment will not be provided as part of this study. This is an imaging study protocol only....

NCT ID: NCT01476657 Terminated - Clinical trials for Hematologic Malignancies

A Phase 1 Study of Duvelisib in Patients With Advanced Hematologic Malignancies

Start date: October 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety, maximum tolerated dose and pharmacokinetics of IPI-145 in patients with advanced hematologic malignancies.

NCT ID: NCT01457131 Terminated - Metastatic Cancer Clinical Trials

Modified White Blood Cells That Secrete IL-2 and Express a Protein That Targets the ESO-1tumor Protein for Metastatic Cancer

Start date: October 6, 2011
Phase: Phase 1
Study type: Interventional

Background: - A new cancer treatment involves collecting white blood cells from an individual, modifying them to secrete IL-2 and target the ESO-1 protein expressed on some cancers, and returning them to the body. The cells may then be able to seek out the cancer cells and destroy them. Some kinds of cancer contain a protein called ESO-1, which is found on the surface of the cells. Doctors want to modify white blood cells to have an anti-ESO-1 effect, and use them to treat the cancer that has the ESO-1. In addition to adding genes that target the ESO-1 protein to the cells, the genes for IL-12 are added to the cells. IL-12 is a protein that stimulates the immune system. This type of therapy is called gene transfer. Objectives: - To test the safety and effectiveness of anti-ESO-1/IL-12 white blood cells against metastatic cancer. Eligibility: - Individuals at least 18 years of age who have metastatic cancer that expresses ESO-1 and has not responded to standard treatments. Design: - Participants will be screened with a medical history and physical exam. They will also have blood tests and imaging studies. - Participants will have leukapheresis about a month before the treatment to collect white blood cells. - They will have chemotherapy 5 days before the treatment to suppress the immune system, and prepare the body for the anti-ESO-1/IL-12 cells. - The anti-ESO-1/IL-12 cells will be given as an infusion. - Participants will be monitored in the hospital during their recovery from the treatment. - Participants will have regular followup exams every 1 to 6 months. The exams will include blood tests, imaging studies, and other studies. Due to toxicities seen with the regimen, it was decided not to pursue the phase 2 portion of the study.

NCT ID: NCT01456143 Terminated - Clinical trials for Head and Neck Cancer

Optical Imaging of Head and Neck Cancer

Start date: December 2011
Phase: N/A
Study type: Interventional

This study examines if certain imaging techniques and devices can aid the surgeon in detecting cancer during the surgical procedure.

NCT ID: NCT01445340 Terminated - Neoplasms Clinical Trials

Topical Romidepsin to Treat Early-Stage Cutaneous T-Cell Lymphoma

Start date: April 21, 2007
Phase: Phase 1
Study type: Interventional

Background: - Cutaneous T-cell lymphoma (CTCL) is a rare, slow-growing form of skin cancer. The cancer cells are found in red, scaly patches that may sometimes itch. - Early-stage CTCL is usually treated with topical therapies, which may lose effectiveness over time and have adverse effects, such as risk of secondary skin cancers and difficulty of use. - Romidepsin is an experimental drug that, given through a vein, has improved CTCL in some patients with later stages of the disease. - A topical ointment form of romidepsin may be helpful in treating early-stage CTCL. Objectives: - To determine the highest tolerated dose of topical romidepsin that can be given to patients with early-stage CTCL. - To evaluate the effectiveness of topical romidepsin in patients with early-stage CTCL. - To determine how the body handles topical romidepsin. Eligibility: -Patients 18 of age and older with early-stage CTCL. Design: - Study Part 1: Successive groups of 3 patients are treated with increasingly higher concentrations of topical romidepsin until the highest tolerated dose is found. - Study Part II: The highest tolerated dose, as determined in Part I, is applied to larger areas of skin in another group of patients. - All study participants apply the study medicine to their skin three times a day for 4 weeks. - During treatment, participants are monitored at weeks 2 and 4 with a history and physical examination, blood tests, electrocardiogram, skin biopsies and photographs of the skin. - After stopping treatment, participants return to the clinic at weeks 6 and 8 for blood tests and to see how the study medication is affecting the body.

NCT ID: NCT01441115 Terminated - Cancer Clinical Trials

ECI301 and Radiation for Advanced or Metastatic Cancer

Start date: September 6, 2011
Phase: Phase 1
Study type: Interventional

Background: - ECI301 is a drug that may help make cancer cells more visible to the immune system after radiation. The drug may also help the immune system destroy the cancer at sites that have not received radiation therapy. Researchers want to study ECI301 in people with advanced cancer or cancer that has spread in the body (metastatic). Objectives: - To test ECI301 with radiation therapy for advanced or metastatic cancer. Eligibility: - People at least 18 years of age with either metastatic or advanced cancer that may benefit from radiation therapy. Design: - Participants will be screened with a medical history and physical exam. They will also have blood and urine tests, and imaging studies. - All participants will have radiation therapy 5 days a week for 2 weeks. - They will have different doses of ECI301 to test its safety and effectiveness. ECI301 will be given in a vein during the second week of radiation therapy. Frequent blood tests and imaging studies will monitor the treatment. - After participants have ECI301, tumor samples may be taken from the site that had radiation and another site that did not have radiation. - Follow-up visits will include blood tests and imaging studies.

NCT ID: NCT01428219 Terminated - Clinical trials for Prostate Cancer Metastatic

Trial of Cabozantinib (XL184) in Castrate-Resistant Prostate Cancer Metastatic to Bone

Start date: February 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to look at the effects of cabozantinib on castrate-resistant prostate cancer metastatic (cancer that has spread to other parts of the body) to the bone and to learn about any side effects caused by taking cabozantinib.