Study of Noni in Cancer Patients
NeoplasmsNeoplasm MetastasisThe purpose of this Phase 1 study is to: 1. determine the maximum tolerated dose of capsules containing 500mg of freeze dried noni fruit extract, 2. define toxicities associated with the ingestion of noni, 3. collect preliminary information on the efficacy of noni in respect to anti-tumor and symptom control properties to help select specific patients for subsequent Phase 2 studies, 4. identify chemical constituents of the extract that can be used to characterize the bioavailability and pharmacokinetics of noni food supplement.
Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Density in Hormone Sensitive...
Prostate CancerThe purpose of this trial with Zometa is to investigate the effect ZOMETA 4 mg (zoledronic acid for injection in 100mg solution ) has in preventing associated bone loss in prostate cancer patients with bone metastasis when administered in conjunction with hormonal cancer therapy. This trial will seek to determine the effect of ZOMETA in stabilizing and increasing bone mineral density in these patients. This prospective, open-label, single arm, multicenter study will enroll approximately 200 prostate cancer patients with a history of at least one documented bone lesion documented by bone scan or radiograph. Patients must already be receiving hormone therapy and meet the following additional criteria: 18 years of age or older Histologically confirmed diagnoses of prostate cancer Confirmed objective evidence of metastatic bone disease as evidenced by bone scan or radiograph Received or will receive hormonal treatment also know as androgen deprivation therapy with an LHRH agonist or other hormonal treatments Throughout the course of this 12-month trial, patients will be identified based on the duration of established hormonal treatment at the time of enrollment. Each patients duration of participation will be up to 56 weeks including a 4 week screening, 48 week treatment and a 4 week follow up.
Magnetic Resonance Imaging-guided Thermal Radiofrequencey Ablation of Primary Renal Cell Carcinoma,...
Kidney CancerMetastatic Cancer2 moreRATIONALE: Radiofrequency ablation uses high-frequency electric current to heat and kill tumor cells. Magnetic resonance imaging-guided radiofrequency ablation may an effective treatment for primary kidney cancer, liver metastases, or other solid tumors. PURPOSE: Phase II trial to study the effectiveness of magnetic-resonance-guided radiofrequency ablation in treating patients who have primary kidney cancer, liver metastases, or other solid tumors.
Combination Chemotherapy in Treating Patients With Unresectable Liver Metastases From Colorectal...
Colorectal CancerMetastatic CancerRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Cryosurgery kills cancer cells by freezing them. Combining more than one chemotherapy drug with cryosurgery and giving drugs in different ways may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of intrahepatic and intravenous combination chemotherapy with or without cryosurgery in treating unresectable liver metastases from colorectal cancer.
Gene Therapy in Treating Patients With Colon Cancer That Has Spread to the Liver
Colorectal CancerMetastatic CancerRATIONALE: Gene therapy may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the safety of NV1020 in patients who have colon cancer that has spread to the liver and has not responded to previous chemotherapy.
Helical Tomotherapy as a Radiotherapy Technique for Treating Bone Metastases
Bone NeoplasmsTo assess the safety and efficacy of a single fraction of radiotherapy using helical tomotherapy to treat bone metastases.
Evaluating Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer Following...
Colorectal CancerMetastatic CancerThe purpose of this study is to determine that panitumumab will have clinically meaningful anti-tumor activity in patients with metastatic colorectal cancer who have developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy.
Pemetrexed and Carboplatin in Locally Advanced or Metastatic Breast Cancer
Breast CancerNeoplasm MetastasisThis is a nonrandomized study of pemetrexed plus carboplatin, with the primary objective of determining the efficacy of the combination in tumor reduction, in patients with locally advanced or metastatic breast cancer.
Chemoembolization in Treating Patients With Primary Liver Cancer or Metastases to the Liver
Liver CancerMetastatic CancerRATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. PURPOSE: Phase II trial to study the effectiveness of chemoembolization in treating patients who have primary liver cancer or metastases to the liver that cannot be surgically removed.
Treatment of Patients With Cancer With Genetically Modified Salmonella Typhimurium Bacteria
CancerNeoplasm1 moreThis study will examine the safety and toxicities of intravenously administering a genetically modified type of Salmonella bacteria (VNP20009) and its impact on tumor growth in advanced or metastatic cancer (cancer that has spread from the primary site). The first patients in the study will be given the smallest dose of VNP20009, and those who enter later will receive increasingly larger doses. This will be done to determine the maximum dose that can be given without serious side effects. Normally, Salmonella bacteria ingested in food or water can cause diarrhea or more severe illness. The bacteria in this study are altered genetically so they can be injected through a vein and circulate in the blood with less likelihood of causing side effects. It is believed that the bacteria will travel in the blood to the tumor and infect it. In studies of mice, tumor growth slowed in animals whose tumors were infected with VNP0009. Patients with advanced or metastatic cancer 18 years of age or older whose disease is not responding to standard treatment, or for which there is no treatment, may be eligible for this study. Candidates will undergo a medical history and physical examination, including blood tests, scans, X-rays, electrocardiogram, and urine, stool and blood cultures. Study participants will be admitted to the hospital for 2 to 4 days. On day 1, they will receive the first dose of VNP0009, infused over a 30-minute period through an intravenous catheter (a small plastic tube inserted into a vein). Blood will be drawn every day to determine if the bacteria are still in the body. After discharge, patients will return to the hospital on days after approximately 1-2 weeks and again after 4-5 weeks for additional blood tests to measure levels of the bacteria and for collection of blood, urine and stool samples. Patients whose tumors are on or just beneath the skin may be asked to have one or two tumors removed surgically. Patients will have tests after approximately 4-5 weeks, including CTs and X-rays, to determine the size and extent of the tumor. Patients whose tumor remained the same size or smaller than before starting treatment, and whose side effects were acceptable will be offered a second treatment cycle. Those whose tumor grew during treatment will be taken off the study. Patients remaining in the study will begin the second cycle on approximately day 36. Tumor growth will be evaluated again between days 64 and 70, and a third cycle will be offered to patients whose tumors have remained stable or have shrunk. Patients may have up to 12 treatment cycles as long as evaluations continue to show the tumor is stable or shrinking. Completing all 12 cycles takes about 13 months. Patients will continue to be evaluated after treatment ends, if they agree to continued follow-up. Patients must follow health precautions to prevent infecting others with Salmonella bacteria as long as they, themselves, remain infected. These include, for example, stringent hand washing practices and avoiding contact with people with weakened immune systems. All the precautions will be explained to the study participants. Patients who leave the study must take antibiotic therapy to rid the body of any remaining bacteria. They will return for urine, stool and blood cultures 30 days after the start of antibiotics, and may undergo three types of scans to look for sites of infection. Treatment will be given as needed.