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NCT ID: NCT01558544 Recruiting - Cancer Clinical Trials

Cryopreservation of Ovarian Tissue

Start date: April 1997
Phase: N/A
Study type: Interventional

The study hopes to contribute to the development of technologies of ovarian tissue freezing-thawing and in vitro maturation of immature eggs such that a person at risk for premature ovarian failure might be able to conceive a genetically related child.

NCT ID: NCT01553656 Completed - Cancer Clinical Trials

Dose-Finding Study of Cabozantinib (XL184) in Japanese Subjects With Advanced Cancer

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

The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics (PK), pharmacodynamics, pharmacogenomic (PGX) and preliminary efficacy following daily oral doses of cabozantinib (XL184) in Japanese patients with advanced or metastatic solid tumors. Also, the effect of XL184 in the treatment of non-small cell lung cancer (NSCLC) patients with various activating mutations will be evaluated at the recommended Phase 2 dose.

NCT ID: NCT01548170 Completed - Cancer Clinical Trials

To Assess the Interaction Between Sunitinib and Ketoconazole to Reduce the Dose and Cost of Sunitinib

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

Sunitinib is an ATP competitive tyrosine kinase inhibitor of several membrane receptors including VEGFR-1, -2, and -3, PDGFR-α and -β, c-KIT, CSF-1R, FLT-3, and RET. Through this molecular mode of action, sunitinib is able to avoid tumoral angiogenesis and proliferation. Sunitinib is already approved by the FDA, EMEA and AEMPS for the treatment of patients with metastatic renal cell carcinomas and those with metastatic gastrointestinal stromal tumors (GIST) with progression or intolerance to imatinib. Suntinib has recently reported to be superior than placebo in terms of response rate (9.3% vs. 0%; p<0.05), progression free survival (11.4 vs. 5,5 months; HR 0.41;p<0.05), and overall survival (HR 0.40;p<0.05) when administered in a phase 3 trial to patients with advanced pancreatic neuroendocrine tumors (NETs). Sunitinib is an expensive drug that drains the budget of health public system therefore it demands a rational drug use. Sunitinib is metabolized by CYP3A4, that belongs to the P450 cytochrome system in the liver. Most of the drug is eliminated in faeces and only 16% by urine. Sunitinib has no food-effect when taken with meals. Pharmacokinetics parameters did not differ between cancer patients and healthy volunteers. Houk et al. Showed that the area under the curve of plasmatic concentration of sunitinib and its active metabolite did correlate with clinical outcome. In other words, the higher plasma concentration area under the curve the highest rates of radiological response, progression free and overall survival rates. Ketoconazol is an antifungal drug that inhibits the CY3A4 inducing an elevation of peak plasma levels of other drugs administered simultaneously and that are metabolized by the same system. In the labeling sheet of sunitinib it is said that ketoconazol induced a 49% and 51% of increase of plasmatic sunitinib Cmax y AUC0-∞ when both drugs were administered together. This fact makes that the investigatorspropose that by administering both drugs simultaneously the investigators could reduce sunitinib dose by a lower metabolization with similar plasma concentration. The dose reduction would impact in drug cost. Here the investigators propose to determine the most optimal combination dose of sunitinib (25 mg or 37.5 mg) and ketoconazol (200mg o 400mg) by which the investigators could have plasmatic bioequivalent concentrations compared with single dose of sunitinib 50mg. Each volunteer will be assigned to a treatment arm (Arm A and Arm B). Volunteers included in Arm A will take: sunitinib 50 mg, sunitinib 37.5 mg + ketoconazole 200 mg and sunitinib 37.5 mg + 400 mg ketoconazole. Volunteers included in Arm B will take: sunitinib 50 mg, sunitinib 25 mg + ketoconazole 200 mg and sunitinib 25 mg + 400 mg ketoconazole

NCT ID: NCT01542879 Recruiting - Cancer Clinical Trials

Development of Radiation Free Whole Body Magnetic Resonance (MR) Imaging Technique for Staging Children With Cancer

Start date: February 2012
Phase: Phase 1/Phase 2
Study type: Interventional

A research study on the diagnosis of spread of disease for children who have been diagnosed with solid tumors using a new whole body imaging technique and a new MR contrast agent (ferumoxytol). Standard tests that are used to determine the extent and possible spread of a child's disease include magnetic resonance (MR) imaging, computed tomography (CT), Positron Emission Tomography (PET) as well as bone scanning, and metaiodobenzylguanidine (MIBG) scanning. The purpose of this study is to determine if newer imaging tests referred to as whole body diffusion-weighted MR and whole body PET/MR can detect the extent and spread of the disease as accurately or even better as the standard tests (CT, MR and/or PET/CT). The advantage of the new imaging test is that it is associated with no or significantly reduced radiation exposure compared to standard CT and PET/CT imaging tests. The results of whole body MR and PET/MR will be compared with that of the conventional, standard imaging studies for tumor detecting.

NCT ID: NCT01539148 Recruiting - Cancer Clinical Trials

A Five-Year Quality of Life Study for Cancer Patients

IPTLD
Start date: March 2010
Phase: N/A
Study type: Observational

The investigator is looking for patients who have been diagnosed with stage 1-4 cancer to enroll in a five year Quality of Life clinical trial study in which the participant has previously elected to use Insulin Potentiation Targeted Low Dose (IPTLD) as a means to treat their illness. This study is a quality of life study and not a treatment study. Participants participating in the study will be asked to complete quality of life questionnaires. The questionnaires completed by the patients will measure mood, energy level, ability to function, level of pain, and other measures that indicate how a patient feels about the quality of their daily living.

NCT ID: NCT01538563 Completed - Cancer Clinical Trials

Safety of 24-Hour Infusion of ON 01910.Na in Patients With Advanced Cancer

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

The primary purpose of this study is to determine the highest dose of ON 01910.Na that can be safely given as an intravenous infusion over 24 hours once a week in a 3-week cycle to patients with advanced solid tumors.

NCT ID: NCT01538537 Completed - Cancer Clinical Trials

Safety of ON 01910.Na as a 3-day Infusion in Patients With Advanced Cancer

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

The primary objective of this study is to determine the largest dose of ON 01910.Na (rigosertib sodium) that can be given safely as a 3-day continuous infusion once every 2 weeks (2-week cycle) in patients with advanced cancer.

NCT ID: NCT01536691 Recruiting - Cancer Clinical Trials

Ramosetron, Aprepitant and Dexamethasone Versus Ondansetron, Aprepitant and Dexamethasone

ROAD
Start date: June 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of Ramosetron, Aprepitant and Dexamethasone therapy versus Ondansetron, Aprepitant and Dexamethasone therapy for preventing of nausea and vomiting in highly emetogenic chemotherapy (ROAD study): Prospective multicenter, randomized, single blinded, phase III study.

NCT ID: NCT01531894 Completed - Cancer Clinical Trials

Continuation Study of the Oral AKT Inhibitor GSK2110183

Start date: February 8, 2012
Phase: Phase 2
Study type: Interventional

This multicenter, non-randomized, open-label, treatment continuation or 'rollover' study was designed to provide continued access to eligible subjects who had previously participated in a GSK2110183 study (parent study) sponsored by GlaxoSmithKline (GSK) or another research organization working on behalf of GSK. Eligible subjects had previously received clinical benefit from continued treatment and had to have ad an acceptable safety profile with GSK2110183. Subjects who had participated in a GSK2110183 combination study with an approved anti-cancer agent were also be eligible to enroll in this rollover study. Subjects who participated in combination studies with two investigational compounds (one being GSK2110183) were not eligible for this rollover study. Subjects were enrolled by cohort based on the duration and treatment received while in their parent study. Safety assessments (physical examinations, vital sign measurements, 12-lead electrocardiograms, echocardiograms or multiple-gated acquisition scans, clinical laboratory assessments and monitoring of adverse events) were evaluated during this study. Disease assessment were performed using local standard of care imaging practices and criteria appropriate for disease type and location.

NCT ID: NCT01531478 Completed - Cancer Clinical Trials

Long-term Follow-up of Childhood Cancer Survivors in the Rhône-Alpes and Auvergne Regions of France

SALTO
Start date: May 2011
Phase: N/A
Study type: Observational

Childhood cancers are rare, and today 75% of patients survive them. An estimated one out of 850 French persons has survived childhood cancer. However, the complications of chemotherapy, radiotherapy or surgery can lead to a higher risk of secondary mortality, which the literature estimates is at 14%. Regular care has a positive impact on the quality of life and health of adults who survived cancer during their childhoods. It aims to detect the potential long-lasting effects of cancer and to provide therapeutic education and psychological care. Thanks to cancer registries, several countries (USA, Canada, UK, Germany, the Netherlands) have developed long-term care structures which function with specially trained adult medicine practitioners. There are only two structures in France: the Long-Term Oncology/Hematology Follow-Up Clinic, headed by Dr François Pein, in Nantes (France), and the LEA program for the follow-up of children treated for leukemia in the PACA-Corse and Lorraine regions of France, which began in 2003 and has since been extended to other centers. The Rhône-Alpes and Auvergne regions have had childhood cancer registries since 1987; they compile about 200 new cases a year. The Rhône-Alpes registry has conducted a preliminary trial on children (0-15 years old) diagnosed with cancer between 1987 and 1992. They analyzed the correlation between patients' quality of life and the long-term medical effect of cancer and treatment, both recorded in patients' medical files and declared by patients. These young adults who survived pediatric cancer appear to suffer from and declare many complications, although this does not impact their global quality of life much. There is a negative correlation between the number of complications (observed or declared) and the global quality of life score, but only three types of complications play a significant role (motor function complications, auditory complications, and alopecia.) In addition, there is a significant mismatch between patients's perceived health (what they say they experience), and the information contained in their medical files. These young adults expressed the need for their impressions to be better taken into account by health care professionals. This study does not assess patients' psychopathological characteristics.