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Neoplasm Metastasis clinical trials

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NCT ID: NCT00851084 Completed - Clinical trials for Colorectal Neoplasms

Study of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer

AFFIRM
Start date: February 2009
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to estimate the progression-free survival rate at 12 months for the two arms of the study. Secondary objectives include the evaluation of overall objective response rate to treatment, progression-free survival, overall survival, safety and documentation of potential immunogenicity of aflibercept. This study was a non-comparative randomized trial and was not powered for a comparison of any of the efficacy endpoints. Rather, the aim of the trial was to get, for all endpoints, an estimation of the efficacy and safety of aflibercept combined with a modified FOLFOX6 regimen. In such type of non-comparative randomized trial, the control FOLFOLX6 arm was intended to only act as a check on the similarity of the current patients to the historical controls with respect to clinical outcome when given FOLFOX6 treatment.

NCT ID: NCT00848510 Completed - Clinical trials for Colorectal and Ovarian Cancer Patients With Liver Metastases

EMD 525797 in Colorectal and Ovarian Cancer Patients With Liver Metastases

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

This study is intended to test an experimental drug called EMD 525797 (Abituzumab). This drug is not yet approved for sale and has only been tested in a small number of people to date (prior to this study starting another research study was carried out involving 37 healthy volunteers receiving the study drug). Until more is known about this study drug, it can only be used in research studies. This research study is planned to answer important questions about how the study drug is tolerated and how it may work in subjects with ovarian and colorectal cancer which has spread to the liver (i.e. metastatic cancer). The Sponsor (Merck KGaA) of this study is developing the study drug.

NCT ID: NCT00838929 Active, not recruiting - Brain Metastases Clinical Trials

Study of the Combination of Vorinostat and Radiation Therapy for the Treatment of Patients With Brain Metastases

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

Vorinostat in combination with radiation therapy can be administered safely and will be tolerated in patients with brain metastases, while providing an assessment of the anti-tumor activity of this combination. This is a multi-center, open-label, non-randomized Phase I study in patients with brain metastases. Patients will be administered oral Vorinostat and radiation therapy and will be treated for 3 weeks. Patients will be enrolled in cohorts and will be treated at sequentially rising dose levels of Vorinostat combined with radiation therapy. We will initially enter 3 subjects at each dose. If none of the three experiences a dose-limiting toxicity we will proceed to the next dose. If one of the three experiences that level of toxicity, we will accrue 3 more subjects at that dose. If at any time there are two or more dose-limiting toxicities (in the 3-6 subjects) on a given dose, we will drop down to a lower dose. Dose escalation will continue until the MTD of Vorinostat and radiation therapy is established. The MTD will then be one dose below the DLT occurring in at least 1 out of 3 subjects (2 out of 6 patients).

NCT ID: NCT00837928 Completed - Clinical trials for Unspecified Adult Solid Tumor, Protocol Specific

Bendamustine and Radiation Therapy in Treating Patients With Brain Metastases Caused by Solid Tumors

Start date: February 19, 2009
Phase: Phase 1
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I trial is studying the side effects and best dose of bendamustine when given together with radiation therapy in treating patients with brain metastases caused by solid tumors.

NCT ID: NCT00835679 Terminated - Liver Metastases Clinical Trials

Cetuximab and/or Dasatinib in Patients With Colorectal Cancer and Liver Metastases That Can Be Removed by Surgery

Start date: December 2009
Phase: Phase 0
Study type: Interventional

This phase 0 trial is studying whether 2 weeks of cetuximab and dasatinib will change tumor cells in patients with colorectal cancer and liver metastases that can be removed by surgery. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

NCT ID: NCT00831545 Completed - Melanoma Clinical Trials

Study to Evaluate the Efficacy and Safety of Temozolomide in Subjects With Brain Metastases of Either Malignant Melanoma, Breast, or Non-small Cell Lung Cancer (P02064)

Start date: December 1, 2000
Phase: Phase 2
Study type: Interventional

The study implies a 2 step study design. Patients are enrolled into 3 separate groups for melanoma, breast, and non-small cell lung cancer. In the first step, 21 patients per disease group are enrolled. If >=2 objective responses (SD, PR, or CR) out of 21 evaluable patients are observed, enrollment continues for other 45 patients as a whole, where response will be positively evaluated if >=10 patients will respond. If <2 objective responses out of 21 evaluable patients per disease group are observed, this(ese) group(s) will no longer be treated with temozolomide.

NCT ID: NCT00830180 Completed - Neoplasms Clinical Trials

Open Label Extension In Cancer Patients

Start date: October 29, 2009
Phase: Phase 2
Study type: Interventional

To evaluate the safety and efficacy of anti-NGF AB in cancer patients with pain due to bone metastases who participated in the double-blind Study A4091003 and who wish to receive open-label therapy.

NCT ID: NCT00828347 Completed - Clinical trials for Secondary Hyperparathyroidism

Maintenance Vitamin D Therapy for Secondary Hyperparathyroidism (2HPT)

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

There are still no established protocols for maintenance therapy with intravenous or oral vitamin D preparations after the iPTH target has been achieved. Therefore, the present study compared the efficacy of two maintenance therapy protocols, i.e., oral administration of alfacalcidol (an oral vitamin D preparation) at a dose of 1.0 ug/day (higher-dose group) or at a dose of 0.25 ug/day (lower-dose group), in patients with secondary hyperparathyroidism who responded to initial maxacalcitol therapy, resulting in the control of iPTH to < 150 pg/mL.

NCT ID: NCT00824213 Completed - Bone Metastases Clinical Trials

Pilot Project: Fast Whole-body Spect Scanning to Improve the Detection of Bone Metastases in Patients With Diagnosed Cancer

Start date: January 2009
Phase: N/A
Study type: Observational

The investigators propose to investigate the performance of the image reconstruction software with resolution recovery correction for bone SPECT studies. The investigators estimate that in only 30 minutes, using this new technique of collimator de-blurring, one could perform a fully 3-dimensional SPECT whole-body bone study, essentially obviating the necessity for doing planar bone studies. In the scope of the proposed project, the investigators group aims to test the hypothesis that one can perform a Tc-99m whole-body SPECT study in the same time as a regular routine planar bone study, with greater localization accuracy, and greater lesion detection. To establish a "gold standard" necessary to assess the performance of the SPECT bone scans, the investigators will compare number of malignant lesions detected in patients who are proven to have metastatic skeletal bone lesions on PET F-18 whole-body scans, with whole-body Tc-99m SPECT lesions. The investigators also propose to compare the detection of SPECT scans with standard planar bone scans. This will allow for two major comparisons (a) the accuracy of SPECT bone studies compared to planar bone studies, and (b) the accuracy of SPECT bone scans compared to F-18 PET studies. Most prior studies purporting to show the superiority of F-18 bone scans to Tc-99 bone scans were done only against either planar scans or a combination of planar scans and partial SPECT studies over the spine. We anticipate that F-18 bone scans, due to the higher counting statistics of PET agents, will show more lesions than SPECT, but the exact increase in sensitivity has never been compared to whole-body SPECT scans.

NCT ID: NCT00823303 Completed - Clinical trials for Chronic Kidney Disease

Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)

PACE
Start date: February 2009
Phase: Phase 4
Study type: Interventional

Secondary Hyperparathyroidism (SHPT) occurs in many patients with kidney disease and leads to bone disease. Active forms of vitamin D, calcitriol and paricalcitol, treat SHPT, but may have different effects on blood calcium. This study will randomize patients with SHPT and stage 3 or 4 CKD to treatment with calcitriol or paricalcitol, and monitor patients for the incidence of high blood calcium, and effectiveness of SHPT treatment.