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Neoplasm Metastasis clinical trials

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NCT ID: NCT01409720 Completed - Clinical trials for Vertebral Bony Metastases

Isometric Muscle Training in Patients With Spinal Bony Metastases Under Radiation Therapy

DISPO
Start date: September 2011
Phase: Phase 2
Study type: Interventional

Standard indications for palliative radiation of bony metastases include pain, spinal cord compression, and impending pathologic fractures. Palliative radiation therapy serves to reduce pain, improve quality of life, and avoid complications. Tailored training of the paravertebral musculature may support radiation therapy and improve above named factors. DISPO was designed to investigate the impact of tailored physical exercise in patients with vertebral metastases as compared to manual therapy (massage etc.). The trial includes patients with painful bony metastases, patients with spinal cord compression or impending pathological fractures are excluded. The investigations are carried out in a prospective randomized controlled phase-II parallel group design.

NCT ID: NCT01395407 Completed - Neoplasm Clinical Trials

Phase I Trial of Stereotactic Radiosurgery Following Surgical Resection of Brain Metastases

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

Brain metastases are the most common adult intracranial tumor, occurring in approximately 10% to 30% of adult cancer patients, and represent an important cause of morbidity and mortality in this population. The standard of care for solitary brain metastasis is surgery followed by whole brain radiation therapy (WBRT). Without WBRT, there are unacceptably high levels of local failure that occur. Local recurrence rates ranged from approximately 45% at 1 year to 60% at 2 years after resection alone. However, aside from improvements in intra-cranial control, it is well documented that WBRT is associated with serious long term side effects, including significant decline in short term recall by as early as 4 months after treatment. Many centers are now offering patients stereotactic radiosurgery (SRS) to the cavity after resection alone to improve local control while avoiding the negative effects of WBRT. There have been several retrospective studies on the use of SRS to the resection cavity alone, from which the 1 year actuarial local control rates range from 35% - 82%. The high rate of in-field local failure suggests that the current dosing regimen used may not be high enough for adequate local control. Currently, the highest local control rates are approximately 80%, but there may be room for improvement with increased dose without significantly increasing the risk of side effects. The investigators propose a trial for patients after surgical resection of solitary brain metastases. The purpose of this trial will be to determine the maximum tolerated dose for single fraction SRS to the resection cavity. There will be three groups based on the resection cavity size. Dose escalation enrollment will be done sequentially within each cohort. You will know which cohort and which specific dose level you are randomized to. After treatment, which will take one day, regardless of cohort, you will be followed closely for treatment outcome and possible side effects. You will be asked to complete three quick surveys at each follow-up appointment regarding quality of life and memory in addition to standard of care surveillance brain MRI and physical exam.

NCT ID: NCT01395056 Completed - Breast Neoplasms Clinical Trials

Study of Chemotherapy With Adoptive Cellular Therapy With DC-CIK Cells in Triple Negative Breast Cancer Patients

DCCIK
Start date: July 2011
Phase: N/A
Study type: Observational

To access the effectiveness of cyclophosphamide combined thiotepa and carboplatin chemotherapy combined with adoptive cellular therapy with dendritic and cytokine-induced killer cells in triple negative metastatic breast cancer patients

NCT ID: NCT01391234 Completed - Bone Metastases Clinical Trials

Rapid Radiation Therapy for Painful Osseous Metastatic Disease

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

The purpose of this research study is to evaluate the safety and effectiveness of an experimental workflow that may result in a faster way to plan and deliver radiation for the treatment of pain caused by metastatic bone tumors (tumors that originally came from another organ and have spread to bones causing pain) or multiple myeloma (a type of cancer that begins in white blood cells that produce antibodies). The current standard of care radiation treatment planning and delivery takes 2 to 3 weeks from start to finish. The investigators have developed an experimental workflow: a radiation treatment planning and delivery workflow called "STAT RT" (STAT means "right away", and RT means radiation therapy). This experimental workflow may shorten the time it takes to plan and treat painful bone metastases to 1 week or less. All steps in this process will be performed within the current standard of care but in a shorter time frame to allow treatment to start sooner. The investigators will evaluate effectiveness by requesting patients to complete pain and quality of life questionnaires before and after treatment. The investigators will also be collecting additional information from their treatments that will help us make future workflows even more efficient.

NCT ID: NCT01387373 Completed - Clinical trials for Metastatic Breast Cancer

Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Breast Cancer

Start date: April 2010
Phase: Phase 2
Study type: Interventional

This is a phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic capecitabine and in patients with a HER2-positive tumour in combination with trastuzumab (Herceptin®) in patient with non-resectable liver metastases from breast cancer. Only patients without extrahepatic disease are included.

NCT ID: NCT01387295 Completed - Clinical trials for Metastatic Breast Cancer

Intra-hepatic Chemotherapy in Patients With Liver Metastases From Breast Cancer and Limited Extrahepatic Disease

Start date: April 2010
Phase: Phase 2
Study type: Interventional

This is a phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic capecitabine and in patients with a HER2-positive tumour in combination with trastuzumab (Herceptin®) in patient with non-resectable liver metastases from breast cancer. Only patients with limited extrahepatic disease are included.

NCT ID: NCT01386606 Completed - Clinical trials for Secondary Hypogonadism

The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)

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

The study will determine the effects of three doses of Androxal(enclomiphene citrate)on morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone (<350 ng/dL)after 6 weeks of continuous dosing.

NCT ID: NCT01386580 Completed - Breast Cancer Clinical Trials

An Open-label, Phase I/IIa, Dose Escalating Study of 2B3-101 in Patients With Solid Tumors and Brain Metastases or Recurrent Malignant Glioma.

Start date: July 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics (PK) of 2B3-101 both as single agent and in combination with trastuzumab. Furthermore, the study will explore the preliminary antitumor activity of 2B3-101 as single agent in patients with with solid tumors and brain metastases or recurrent malignant glioma as well as in patients with various forms of breast cancer with and in combination with trastuzumab in HER2+ breast cancer patients with brain metastases.

NCT ID: NCT01384994 Recruiting - Colorectal Cancer Clinical Trials

Panitumumab After Resection of Liver Metastases From Colorectal Cancer in KRAS Wild-type Patients

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

Up to 50% of patients with colorectal cancer (CRC) develop liver metastasis during the course of their disease. In 30-40% of patients metastasis is confined to the liver. In these patients R0-resection of metastases may contribute to marked improvement of overall survival. Primary resection of liver metastasis is possible in about 15-20% of patients (Scheele 2005, Petrelli 2005). Recent studies indicate that perioperative chemotherapy may improve survival after resection of liver metastases (Portier 2007, Nordlinger 2007). Nevertheless, there is evidence that 70-80% of patients have recurrent disease after resection of liver metastasis. Stratification for the risk of recurrence may be performed using the FONG-score (Fong 1999). This study is designed to investigate the efficacy of postoperative chemotherapy combined with an anti-EGFR treatment using panitumumab. The majority of patients present to the surgeon after chemotherapeutic pretreatment with various not necessarily standardized regimens. Also postoperative therapy after resection of liver metastasis is not a clearly defined standard of care in Germany. Based on the study by Nordlinger et al. an oxaliplatin-based regimen is chosen for postoperative therapy (Nordlinger 2008). For reasons of practicability mFOLFOX6 was selected as the chemotherapy backbone for additive treatment (Allegra 2010). Also, there is evidence that the combination of FOLFOX with panitumumab is associated with enhanced antitumor activity (Douillard et al. ESMO 2009). The experimental treatment arm will therefore evaluate the combination of FOLFOX plus panitumumab. Since in colorectal cancer monoclonal antibodies directed against the EGFR are not active in KRAS mutant patients, the experimental arm including panitumumab will only be performed in KRAS wild-type patients (Amado 2008). The planned study aims to assess the efficacy of postoperative therapy with FOLFOX plus panitumumab followed by maintenance with panitumumab for 3 months in KRAS wild-type patients, compared to the historical data for standard FOLFOX chemotherapy alone, which are verified by a randomised control group without the antibody. (Figure 1: Study Design). The study will allow preoperative treatment with regimens such as FOLFIRI, XELIRI, FOLFOX or XELOX +/-bevacizumab or +/- cetuximab. However, only those patients will be considered eligible who did not progress during preoperative therapy. After surgery, a treatment-free interval of at least 4 weeks, but no longer than 8 weeks will be granted. KRAS-wild-type patients (60% of all pts) will then be randomized in a 2:1 ratio to an experimental arm with FOLFOX + panitumumab or to a reference arm with FOLFOX alone. Combination treatment will be performed for a duration of 3 months, after which patients in the experimental arm will receive maintenance therapy with panitumumab for further 3 months. In the reference arm, treatment will, however, be ended after 3 months.

NCT ID: NCT01373164 Completed - Pancreatic Cancer Clinical Trials

A Study in Metastatic Cancer and Advanced or Metastatic Unresectable Pancreatic Cancer

Start date: June 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Phase 1b: To determine the safe and tolerable dose of galunisertib in combination with gemcitabine in patients with solid malignancy Phase 2a: To compare the overall survival (OS) of patients with Stage II to IV unresectable pancreatic cancer when treated with a combination of galunisertib and gemcitabine with that of gemcitabine plus placebo.