Phase I/II evaluation of safety and efficacy of pathotropic nanoparticles bearing a dominant negative cyclin G1 construct (Rexin-G) as intervention for recurrent or metastatic pancreatic cancer.

The purpose of this study is to determine the dose limiting toxicity and maximum tolerated dose of Rexin-G and to identify anti-tumor response among patients with recurrent or metastatic pancreatic cancer considered to have failed or been intolerant of standard chemotherapy.

The patients receive intravenous infusions of Rexin-G beginning at a frequency of 2-3 times per week. The treatment cycle lasts four weeks and is followed by two weeks of rest.

The primary endpoint is defined by the patient’s performance status, his toxicity assessment for hematologic and metabolic profiles. Secondarily, immune responses and the newly combination events and unwanted vector integration are also studied as we determine the objective tumor response to Rexin-G.

The purpose of this study is to determine the dose limiting toxicity and maximum tolerated dose of Rexin-G and to identify anti-tumor response among patients with recurrent or metastatic osteosarcoma considered to have failed or been intolerant of standard chemotherapy.

The patients receive intravenous infusions of Rexin-G beginning at a frequency of 2-3 times per week. The treatment cycle lasts four weeks and is followed by two weeks of rest.

The primary endpoint is defined by the patient’s performance status, his toxicity assessment for hematologic and metabolic profiles. Secondarily, immune responses and the newly combination events and unwanted vector integration are also studied as we determine the objective tumor response to Rexin-G.

The purpose of this study is to determine the dose limiting toxicity and maximum tolerated dose of Rexin-G and to identify anti-tumor response among patients with recurrent or metastatic soft-tissue sarcoma considered to have failed or been intolerant of standard chemotherapy.

The patients receive intravenous infusions of Rexin-G beginning at a frequency of 2-3 times per week. The treatment cycle lasts four weeks and is followed by two weeks of rest.

The primary endpoint is defined by the patient’s performance status, his toxicity assessment for hematologic and metabolic profiles. Secondarily, immune responses and the newly combination events and unwanted vector integration are also studied as we determine the objective tumor response to Rexin-G.

The purpose of this study is to determine the dose limiting toxicity and maximum tolerated dose of Rexin-G and to identify anti-tumor response among patients with recurrent or metastatic breast cancer considered to have failed or been intolerant of standard chemotherapy.

The patients receive intravenous infusions of Rexin-G beginning at a frequency of 2-3 times per week. The treatment cycle lasts four weeks and is followed by two weeks of rest.

The primary endpoint is defined by the patient’s performance status, his toxicity assessment for hematologic and metabolic profiles. Secondarily, immune responses and the newly combination events and unwanted vector integration are also studied as we determine the objective tumor response to Rexin-G.

The purpose of this study is to determine overall objective tumor response rate of the patients with tumors outlined above. We will also estimate the duration of response and progression-free survival. PET scan changes in the patients will be explored, pharmacokinetic profile of R1507 will be explored, and tolerability as well as adverse event profile of this molecule will be determined in the patient population.

The patients who have life expectancy of at least six weeks and Karnofsky performance status greater than 70% will receive intravenous infusions of R1507. The patients must have measurable disease by imaging techniques and adequate organ functions of the bone marrow, liver and the kidneys. Certain inclusion and exclusion criteria will be met and can be verified at this center through further inquiry.

This intravenous infusion is given on weekly basis with the above mentioned objectives of study. The treatment will continue until we find there is disease progression or other intercurrent illness prevents further administration. Unacceptable adverse events or withdrawal by the patient are also reasons for discontinuation of study.

The purpose of this study is to identify a dose of AMG 655 in combination with doxorubicin that is safe and tolerated.

The second purpose of this study is to estimate the efficacy as measured by progression-free survival. Drugs are given intravenously once every 21 days, and then disease response is studied radiologically.

Eligibility is for subjects with unresectable soft-tissue sarcoma who have histologically confirmed disease, which is locally advanced or recurrent, metastatic or unresectable. It could be of intermediate or high grade. Certain sarcomas are not eligible such as alveolar soft part sarcoma, clear cell sarcoma, chondrosarcoma, desmoid tumor, desmoplastic round cell tumor and embryonal rhabdomyosarcoma, Ewing’s sarcoma, primitive neuroectodermal tumors, gastrointestinal stromal tumors, Kaposi sarcoma, mesothelioma, mixed mesodermal tumor, neuroblastoma, and osteosarcoma.

The purpose of this study is to determine the biological activity and safety profile of Indibulin capsule when administered orally for 21 days followed by one week of using a twice daily schedule in subjects with advanced solid tumors. These are 600 mg capsules given twice a day for a total of 1200 mg per day for three weeks. The study duration can be until disease progression or unacceptable toxicity occurs./p>

The patient will be studied for disease response through radiologic means.

This protocol is designed to explore the efficacy of single agent Brostallicin administered once every three weeks for the patients with myxoid liposarcoma with 12-16 translocation. Once the histology has been confirmed, the patients are checked for inclusion criteria such as disease to be metastatic or unresectable but measurable by CT scan or by other acceptable imaging methods. The patients must have a life expectancy of at least three months and acceptable renal and liver functions and adequate blood counts.

Once enrolled, the patients will be given the medication with the primary objective of determining the overall response rate. The patients will also be participating for determination of progression-free survival and duration of response. This is an intravenous infusion.

Further details are available at this center.

This is a phase II study for patients with giant cell tumor of the bone and the purpose of this study is to evaluate response to treatment of denosumab in subjects with recurrent or unresectable giant cell tumor. Response is identified as at least 90% elimination of giant cells related to baseline or complete elimination of giant cells when less than 5% are present to begin with.

Subjects are given subcutaneous injections of 120 mg of denosumab on days 1, 8, and 15, and then from day 29 onwards, every four weeks thereafter. The patients have been assessed for response of their disease through various radiologic measurements.

Eligible subjects need to have a measurable disease by radiologic means and must be over 18 years of age.

The goal of the study is to study a daily oral dose of perifosine in the patients with chondrosarcomas, alveolar soft part sarcomas, and extraskeletal myxoid chondrosarcomas. Response to therapy will be based on regression of measurable disease.

The patients are given 50 mg tablet in appropriate doses and then their disease response is measured. To be eligible for this study, the person must have one of the above tumor types.

The purpose of this study is to study their response to intravenous 24-hour infusion of Yondelis. Yondelis acts on the DNA by altering its special architecture. This drug is given to people who have been previously treated and who have had soft-tissue sarcoma and who cannot be expected to benefit from currently available therapeutic options. The treatment is usually given every 21 days and side effects as well as the tumor response are studied over the weeks. Subjects to be included in the study have soft-tissue sarcoma. If the eligibility criteria have been met with our review, they can then access this study protocol.

The purpose of this study is to determine the maximum tolerated dose of AMG 655 that can be administered in combination with gemcitabine.

The second purpose of this study is to determine the efficacy assessed by six-month survival of AMG 655, AMG 479, or AMG 655-placebo in combination with gemcitabine.

The patients are eligible for this study based upon acceptable status of the bone marrow, liver functions, and kidney functions.

The drugs are given intravenously in combination and are given on different days of the week such as day 1, day 8, day 15 of a 28-day cycle.

Appropriate radiologic studies are then performed to evaluate the response to the drugs.

The purpose of this study is to determine a safety profile of ZIO-201-T administered in combination with doxorubicin in a population which is ifosfamide and doxorubicin naive. The secondary purpose is to study the pharmacodynamics of the drugs given and to determine tumor responses including complete and partial responses.

The drugs are administered on the first day of a 21-day cycle intravenously and given up to three consecutive days.

The patients are then studied with radiologic means for disease response.

The purpose of this study is to treat people with different kinds of sarcoma with dasatinib 70 mg twice daily for 28 days and repeat the cycle every 28 days.

This is tyrosine kinase inhibitor, which inhibits proliferation some cancer cell lines. The protocol is designed to investigate the response rate at two, four and six months or stable disease for six months. The overall survival data at two and five years is being sought.

Subjects after having administered this oral medication will be studied through radiologic means.