View clinical trials related to Solid Tumors.
Filter by:The purpose of this trial is to characterize the safety and toxicity of DKN-01 by determining a maximum-tolerated dose and associated dose limiting toxicity. To evaluate the pharmacodynamic response in patients with cancer. To characterize the pharmacokinetic parameters of DKN-01 in cancer patients who are intolerant to standard/approved therapies.
Background: - Trabectedin is an experimental drug that kills some cancer cells in the laboratory and in mice by interfering with genetic material (DNA) in cancer cells. - In some adult patients with cancer who received trabectedin, tumors grew slower or shrank. Objectives: - To determine a dose of trabectedin that can be given safely to children and adolescents as a 24-hour continuous infusion through a vein. - To determine the side effects of trabectedin in children and adolescents. - To study how the body handles trabectedin by measuring the amount of the drug in the bloodstream over time after a dose is given. - To measure the effect of trabectedin on DNA in white blood cells. - To determine if an individual's tumor cells have a specific proteins involved in DNA repair and if a pattern of genes can be identified in tumor samples that might help explain why trabectedin reduces tumors in some individuals and not others. - To study genetic factors that may influence the way the body handles trabectedin. - To see if trabectedin is beneficial in certain types of cancer. Eligibility: -Children between 4 year and 17 years of age with tumors that recur or no longer respond to standard treatment. Design: - Patients receive trabectedin as a 24-hour continuous infusion repeated every 21 days. The first three children entering the study receive a dose of 1.1 mg/m2. Subsequent groups of up to six patients receive higher doses (1.5 mg/m2 and 1.7 mg/m2) as long as the preceding dose is well tolerated. Patients enrolled at the lowest dose level may have their dose increased to the next level if they tolerated the lower dose well. Treatment may continue as long as the cancer does not worsen and the treatment is tolerated. - Patients have blood drawn on days 1, 2, 3, 4, 5 and 7 of the first treatment cycle to study how the body handles trabectedin. - A tumor sample obtained from a prior surgery or biopsy is examined for proteins involved in DNA repair. - A blood sample is drawn to look for genetic factors that may influence how the body handles trabectedin. - Patients have periodic physical examinations and blood tests. MRI or CT scans are done before starting therapy and after every two treatment cycles to evaluate the tumor.
To evaluate the safety and tolerability of escalating doses of MM-121 + certain anticancer therapies
Background: - Bevacizumab inhibits blood vessel growth in cancer cells by blocking a growth factor called VEGF. Dasatinib inhibits the action of proteins called tyrosine kinases, which promote and stimulate blood vessel formation and cancer growth and spread. - Using the two drugs in combination may provide a more effective cancer treatment than either drug used alone. - Both drugs have been approved by the Food and Drug Administration for different cancer types, but their use in combination sis experimental. Objectives: - To determine the highest doses of the combination of dasatinib and bevacizumab that can be safely given to patients with different cancers and to find out what effects, good and bad, these drugs may have on the patient and the disease. Eligibility: - Adult patients with an advanced solid tumor cancer that cannot be treated successfully with standard therapies. Design: - Patients in Group 1 receive dasatinib and bevacizumab together throughout the study. The dose is increased in successive groups of three to six patients until the optimum safe dose is determined. Patients take dasatinib by mouth once a day and receive bevacizumab as an infusion through a vein once every 2 weeks in 28-day treatment cycles. - Patients in Group 2 are randomly assigned to receive either dasatinib or bevacizumab for cycle one, and then both drugs for all subsequent cycles. The drug doses are based on the optimum doses found in Group 1 patients. - Patients have a physical examination and blood and urine tests every 2 weeks for cycles 1 and 2, and then every 4 weeks for the duration of treatment. - Patients have CT or MRI scans or another imaging test such as ultrasound every 8 weeks to monitor the cancer s response to treatment. - Tumor biopsies are obtained from patients in Group 2 before treatment, 2 weeks into the first treatment cycle, and 2 weeks into the second cycle. - Dynamic, contrast-enhanced MRI (DCE-MRI) tests are done on patients in Group 2 before treatment, 2 weeks into the first cycle and 4 weeks into the second cycle. This MRI test uses a special non-radioactive dye that shows blood flow in a certain part of the body. - For patients who have been on the study over 2 years, the cycle may be lengthened to 6 or 8 weeks at the discretion of the investigator.
Background: - The PI3K/Akt/mTOR pathway is an important target in cancer because it promotes chemotherapeutic resistance and confers a poor prognosis for many types of cancers. - Several inhibitors of the pathway are being developed as cancer therapeutics. However, the process of de novo drug development takes years, and is often curtailed due to diminished activity and/or unforeseen toxicities in clinical trials. - One approach to expedite the development of new cancer therapies is to test drugs that are already approved for other indications. - Our group has shown that nelfinavir, an orally available FDA-approved HIV-1 protease inhibitor used to treat HIV/AIDS, can inhibit endogenous Akt and growth factor receptor induced Akt activity in cancer cells. - Importantly, nelfinavir demonstrates dose-dependent cytotoxicity in every cell line in the NCI 60 cell line panel at plasma concentrations attainable in human plasma, is profoundly effective in cancer cell lines that have been selected to become resistant to standard therapies, and inhibits tumor growth in-vivo. Objectives: - Because an MTD with nelfinavir has not been observed in prior phase I studies with HIV patients, the objectives of the Phase I design will be: - To establish the MTD and dose limiting toxicity for this drug in patients with solid Tumors. - To correlate nelfinavir pharmacokinetics with baseline activity of CYP3A4 as assessed by measuring midazolam clearance. - To preliminarily explore the biological and clinical effects through a series of correlative studies involving analysis of blood and tissue across patients throughout the study. Eligibility: -Adults with solid tumors who are refractory to, or have relapsed after receiving, standard front-line chemotherapies are eligible. Design: - Patients will receive nelfinavir beginning at the FDA-approved dose for HIV patients (1250 mg po bid). - Dose escalations will occur for 6 dose levels i.e. cohorts, or until the MTD is reached. - Up to 45 patients are expected to be enrolled. - Staging CT scans will be performed every two cycles.
This is a multicenter, international, prospective, observational study of patients who are receiving systemic chemotherapy for solid tumour cancers (breast, colorectal, ovarian, prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric) and who are receiving darbepoetin alfa (Aranesp®) or other erythropoiesis-stimulating agent (ESA) to treat symptomatic anaemia. Quality of Life will be assessed electronically with the aim of estimating improvement in quality of life for those patients receiving darbepoetin alfa (Aranesp®) who also have an increase in haemoglobin (Hb) of ≥1 g/dL
This is a multi-center, open label study to assess pharmacokinetics (PK) of TKI258 at single-dose and steady state in adult cancer patients either with mild, moderate or severe hepatic impairment or with normal hepatic function. Hepatic function in study patients will be categorized as normal, mild, moderate or severe based upon pre-dose (Day 1) total bilirubin and AST/ALT levels. Starting dose of TKI258 will depend on total bilirubin and ALT/AST levels at baseline. Patients will be treated until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death or discontinuation from the study treatment for any other reason.
The purpose of this study is to determine the safety and toxicity of the combination of pazopanib and GSK1120212 in patients with solid tumors and identify the maximum tolerated dose (MTD) of this combination for phase II study.
Oncolytic viruses are viruses that can be found in nature, but they have been modified so that they can no longer multiply in normal cells. These viruses "infect" cancer cells and kill them. Once the cancer cell dies thousands of the viruses are released and can potentially infect other cancer cells in the area. The effects of oncolytic viruses on the tumor are felt to be the result of a combination of the oncolytic viruses directly killing the tumor cells as well as the patient's immune system killing cancer cells that are infected with the oncolytic virus. Modern oncolytic viruses have been used for treatment of thousands of patients. The safety of such treatments has been good and there have been no deaths caused by treatment with oncolytic viruses. Many patients have benefited from the treatment in the sense that their tumors have stopped growing, become smaller or even completely disappeared. Some benefits are temporary, but about one third of patients seem to gain longer lasting benefit likely to impact survival. The effect of oncolytic viruses on improving survival has not been demonstrated yet. Oncolytic viruses can be created from many different types of viruses. In this study the investigators are using an oncolytic virus created from an adenovirus. Adenoviruses are the types of viruses that cause the common cold and the flu. Because replication in normal cells does not take place, these oncolytic viruses should not cause any diseases in normal cells. Further, to date there has been no incidence of passing the virus on to other humans from patients who were treated with oncolytic viruses. The purpose of this study is to see the highest dose of CGTG-102 (the oncolytic virus being used in this study) that can safely be given to subjects. The investigators will also evaluate whether or not the CGTG-102 is helpful in reducing the size of the cancer and improving patient survival.
This is a study of dalotuzumab given as monotherapy and in combination with ridaforolimus for pediatric participants with advanced solid tumors. This study will have three parts. Part 1 will find a maximum tolerated dose (MTD) and collect pharmacokinetic (PK) data for dalotuzumab alone. Part 2 will find an MTD and collect PK data for dalotuzumab in combination with ridaforolimus. Part 3 will be an expansion cohort at the recommended Phase 2 dose (RPTD) found in Part 2 to confirm the RPTD and look at the potential efficacy of the combination therapy.