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by Tom Swartz
This trial is currently recruiting patients. No phase is specified for this trial. Diagnostic procedures, such as combined PET scans and CT scans, may help doctors predict a patient's response to treatment and may help plan the best treatment. Drugs used in chemotherapy, such as doxorubicin and ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. This clinical trial is studying PET scans and CT scans to see how well they work in predicting response in patients undergoing chemotherapy and surgery for soft tissue sarcoma. The objectives of the study are: (Primary) - determine whether measurements of fludeoxyglucose (FDG) positron emission tomography (PET)/CT imaging can accurately predict disease-free survival of patients with soft tissue sarcoma who are receiving neoadjuvant chemotherapy; (Secondary) - correlate histological response to neoadjuvant chemotherapy for soft tissue sarcomas with FDG-PET/CT imaging findings; (Tertiary) - determine the changes in FDG-PET/CT imaging over time as each course of chemotherapy is given. Patients receive 1 of 2 standard chemotherapy regimens as follows:
All patients undergo a fludeoxyglucose positron emission tomography(PET)/CT scan at baseline, after course 1, and after completion of chemotherapy. Patients undergo surgery within 4-6 weeks after completion of chemotherapy. After completion of study treatment and surgery, patients are followed every 6 months for 5 years. A total of 56 patients will be accrued for this study. Patients 16 years of age and older are eligible. This trial is taking place at the University of Minnesota Cancer Center, Minneapolis, Minnesota.
This Phase III trial is currently recruiting patients. The purpose of this study is to evaluate the efficacy of BEMA fentanyl at any dose in the management of breakthrough pain in cancer subjects on background opioid therapy. The standard of care for these breakthrough pain episodes is a rapid onset, short acting analgesic with minimal associated sleepiness. Oral morphine, oxycodone and hydromorphone are routinely used, but because of slow and variable oral absorption, the pain control is not the best with these products. In addition, oral transmucosal fentanyl citrate (OTFC) has been used successfully in treating breakthrough pain episodes associated with cancer. OTFC is a lozenge of fentanyl on a stick and is administered by continuously swabbing the interior of the subject’s mouth until the product is dissolved (approximately 15 to 30 minutes). This mouth route of administration avoids the delay and variability associated with oral absorption. Now BioDelivery Sciences International, Inc. (BDSI) has developed BEMA (BioErodible MucoAdhesive) fentanyl, an alternative product to OTFC that does not require the subject to continuously paint the inside of the mouth with the dosage form. The BDSI product is a small disc that is placed against the mucosal membrane inside the mouth. The mucoadhesive polymers in the disc readily adhere to the mucosal membrane (within 5 seconds) when moistened. The components of the disc are water soluble, so the entire dosage form dissolves within 30 minutes of application. Cancer patients 18 years of age with associated cancer pain are eligible. Patients must be on a stable current regimen of oral opioids or transdermal fentanyl and regularly experience 1 - 4 breakthrough pain episodes per day that requires additional opioids for pain control. This trial is taking place in Wilmington, North Carolina. For additional information contact: Jeri Mosley at 910-772-6937.
Newcastle Disease Virus (NDV) for Cancer Patients Resistant to Conventional Anti-Cancer Modalities This Phase II trial is currently recruiting patients. Newcastle Disease Virus (NDV) is a virus that is harmful in chickens, but harmless in man. There are 2 major sub-strains of NDV, one oncolytic and one non-oncolytic. Oncolytic NDV (MTH-68H) preferentially homes and replicates in cancer cells and therefore, administration of NDV intravenously or preferentially intra-tumor, either by direct injection or by injection into an afferent artery results in direct lysis of tumor cells. NDV activates apoptotic mechanism in cancer cells and thus, results in natural cell death. Both oncolytic and non-oncolytic NDV were used clinically in hundreds of patients with different types of cancer worldwide. NDV were proved harmless in man. Clinical studies were done for more than a decade and the efficacy of NDV was documented on pre-clinical animals models as well as in man. For a large number of patients with metastatic cancer and chemotherapy resistant hematological malignances, no cure can be provided by conventional anti-cancer modalities, new treatment options are urgently indicated. Thus, the goal of the study is to use NDV, in order to provide such treatment for patients in need. Patients with metastatic lung cancer, metastatic GI cancer, metastatic urogenital cancer, skin and soft tissue cancer are eligible. This trial is taking place at the Hadassah Medical Organization, Jerusalem, Israel.
Phase I and II Trial With TLC D-99 and Ifosfamide in Metastatic Soft Tissue Sarcoma Patients This Phase I/II trial is not yet open for patient recruitment. TLC D-99 is a liposomal formulation of the anti-neoplastic drug doxorubicin with an improved therapeutic index compared with conventional doxorubicin. The purpose of this study is to determine the maximum tolerated dose of TLC D-99 combined with ifosfamide and then the efficacy of this combination in terms of overall response rate, time to progression and time of response. Soft tissue sarcoma patients 18 years of age and older are eligible. The treatment outline is not set forth. This trial is taking place at the Istituto Clinico Humanitas, Rozzano, Milan, Italy. For further information contact: Armando Santoro, MD, Principal Investigator.
Study of Clostridium Novyi-NT Spores in Solid Tumors Malignancies This Phase I trial is currently recruiting patients. The spore-forming Clostridium species of bacteria are notorious for the frightening toxins they can generate, including botulinum and tetanus toxoid. They also prefer to live where there is little oxygen. Starting with early observations in the 19th century of cancer remission in some patients surviving postoperative infection, investigators have harnessed these two characteristics of Clostridium novyi-NT, for experimental cancer therapy. They injected mice bearing large established tumors with spores of an attenuated strain of the bacterium and showed that the spores exclusively germinated within the hypoxic cores of the tumors and destroyed all but the peripheral oxygenated cells. These cells subsequently continued to expand, but about 30% of the mice were cured of the cancer in the absence of radio- or chemotherapy. This happened because a potent immune response to the cancer cells was generated, such that all the cured mice subsequently rejected transplanted tumor cells of the same type and kept the bacteria under control. Similar success was observed in rabbits and rats, but it has been unknown whether humans would generate similarly effective immune responses (see article: Bacteriolytic therapy can generate a potent immune response against experimental tumors). The instant trial consists of a one time IV infusion of Clostridium novyi-NT spores to treat solid tumors which have not responded to standard therapy. The total expected enrollment is 20 patients. Patients 18 years of age and older are eligible. This trial is taking place at Johns Hopkins Medical Institutes, Baltimore, Maryland.
Inhalation SLIT Cisplatin for the Treatment of Osteosarcoma Metastatic to the Lung This Phase I/II trial is currently recruiting patients. Osteosarcoma preferentially metastasizes to the lung. The presence of lung metastases has a major impact on the prognosis of patients with osteosarcoma. Upon surgical removal of the tumor in the lung, new pulmonary metastases often recur within months suggesting micro-metastatic disease resistant to systemic chemotherapy. The sustained release lipid inhalation targeting (SLIT) technology offers the potential ability to attain a prolonged therapeutic effect of cisplatin in the lung by sustained release. The ability to give SLIT Cisplatin by inhalation directly to the lung permits high drug levels at the site of disease with low systemic exposure. Thus, the purpose of this study is to determine the safety and efficacy of inhaled SLIT Cisplatin administered every other week to patients with Osteosarcoma who have disease that has spread to the lung. Patients will receive SLIT Cisplatin by inhalation for a 14-day treatment cycle. Clinical efficacy endpoints will be included and compared to historical controls, in addition to pharmacokinetics characterization. Efficacy will be evaluated after at least 2 cycles of therapy. Safety data, including laboratory parameters and adverse events will be collected to determine the qualitative and quantitative toxicity, and reversibility of toxicity of SLIT Cisplatin. Pulmonary function tests will be performed at baseline, prior to each course and at off-study. Osteosarcoma patients 13 to 50 years of age are eligible. The total expected enrollment is 21 patients. The study began in January 2005 and is expected to be completed April 2007. The study is taking place at The Albert Einstein College of Medicine Montefiore Medical Center, New York, NY and Memorial Sloan Kettering Cancer Center, New York, NY.
Study of IT-101 in the Treatment of Advanced Solid Tumors This Phase I trial is currently recruiting patients. IT-101 is a nanotechnology formulation being developed by Insert Therapeutics using its Cyclosert™ drug delivery technology platform. IT-101 is comprised of the Cyclosert™ delivery platform in combination with the anticancer compound camptothecin for systemic treatment of solid tumors, both primary and metastatic. Camptothecin is a natural compound found in the bark of the Chinese Camptotheca Acuminata tree. Camptothecin was discovered in the 1960s to possess potent anticancer properties against a broad spectrum of tumor cell lines. Its method of action inhibits the enzyme topoisomerase 1, which is key to the winding and unwinding process of DNA that is an essential step in cell division and replication. Interrupting this process prevents DNA replication and leads to cell death. However, camptothecin presents a formidable challenge for drug delivery technology, and was never successfully developed and commercialized in its native state due to several unfavorable characteristics. First, it is virtually insoluble in water, making any sort of systemic application difficult. Second, at human blood pH levels, it rapidly hydrolyzes from its active lactone form to its carboxylate form, which remains highly toxic, but lacks anticancer properties. Finally, in its carboxylate form camptothecin has a high binding affinity with human blood proteins in vivo which prevents the camptothecin from eventually equilibrating between its active and inactive forms. All of these properties dramatically reduced its efficacy and increased its toxicity in humans compared to results obtained in animal testing. IT-101 (using Cyclosert) is a conjugate of camptothecin (CPT) and a linear, cyclodextrin-based polymer (CDP). The components of CDP are beta-cyclodextrin and polyethylene-glycol (PEG), both of which are used in a variety of drug formulations. Camptothecin is covalently attached to CDP through a glycine linker which preserves CPT in its active form and increases its water solubility by greater than 1000 fold. Once injected into the blood circulation, camptothecin is slowly released from the polymer conjugate through hydrolysis of an ester linkage. In addition to improving solubility and stability, polymer-drug conjugation can enhance the accumulation of the drug in tumors by taking advantage of the enhanced permeability and retention (EPR) effect, a mechanism through which macromolecules extravasate out of the abnormally leaky vasculature of tumors. The instant trial will be an open-label, dose-escalation, study of IT-101 administered in patients with solid tumor malignancies. Patients who satisfy the inclusion/exclusion criteria will receive a weekly injection of IT-101 on Days 1-8-15 followed by a 1 week rest period. Patients may receive up to 6 cycles of IT-101. Patients will be monitored for a response using RECIST criteria every 2 months. Male and female patients 18 years of age and older with advanced solid tumors refractory to standard therapy or for which no standard therapy exists are eligible. The total expected enrollment is 36 patients. The trial is taking place at City of Hope National Medical Center, Duarte, California.
FR901228 in Treating Patients With Metastatic or Unresectable Soft Tissue Sarcoma This Phase II trial is currently recruiting patients. FR901228 is a type of depsipeptide and belongs to the family of drugs called histone deacetylase inhibitors. Depsipeptide binds to and inhibits histone deacetylase, thereby affecting the regulation of gene expression and inducing cell differentiation, cell cycle arrest, and apoptosis. This agent also inhibits hypoxia-induced angiogenesis and depletes several HSP90-dependent oncoproteins. The purpose of this trial is to study how well FR901228 works in treating patients with metastatic or unresectable soft tissue sarcoma. Patients receive FR901228 IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR. After completion of study treatment, patients are followed every 2 months. A total of 18-36 patients will be accrued for this study within approximately 1 year. Patients 18 years of age and older are eligible. This study is taking place at centers in Arizona, California, Georgia, Illinois, North Carolina, Ohio, South Carolina, and Virginia.
Nelfinavir Mesylate in Treating Patients With Recurrent, Metastatic, or Unresectable Liposarcoma This phase I/II trial is currently recruiting patients. Nelfinavir mesylate is a protease inhibitor which may help prevent cancer cells from spreading. It is a "Molecular Targeted Therapy" against an adipogenic (fat cell) transcription factor (protein that induces gene expression), SREBP-1 (Sterol Regulatory Element Binding Protein-1). The purpose of this trial is to study the side effects and best dose of nelfinavir mesylate and to see how well it works in treating patients with recurrent, metastatic, or unresectable liposarcoma. This is a phase I dose-escalation study followed by a phase II study. In the Phase I part of the study, patients receive oral nelfinavir mesylate twice daily in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of nelfinavir mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. In the Phase II part of the study, patients receive nelfinavir mesylate as in phase I at the MTD. A total of 40 patients will be accrued for this study. Patients 18 years of age and older are eligible. This trial is taking place at the City of Hope Comprehensive Cancer Center, Duarte, California.
This Phase I trial is currently recruiting patients. Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances, such as radioactive iodine, to them without harming normal cells. Thus, the purpose of this trial is to study side effects and best dose of radiolabeled monoclonal antibody therapy in treating patients with refractory, recurrent, or advanced central nervous system or leptomeningeal cancer. Patients with the following sarcomas are eligible: rhabdomyosarcoma, soft tissue sarcoma, rhabdoid tumor of the central nervous system, desmoplastic small round-cell tumor, osteosarcoma, and Ewing's family of tumors. This is a dose-escalation study. Patients receive iodine I 131 monoclonal antibody 8H9 (^131I MOAB 8H9) intrathecally on day 1. Treatment repeats every 4 weeks for up to 2 courses (total of 2 injections) in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ^131I MOAB 8H9 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A total of 3-30 patients will be accrued for this study within 2-3 years. Patients of any age are eligible. This trial is taking place at Memorial Sloan-Kettering Cancer Center, New York, NY.
Safety, Tolerability and Maximum Tolerated Dose of Oral AP23573 in Combination With Doxorubicin This Phase I trial is currently recruiting patients. This study is designed to determine the safety, tolerability and maximum tolerated dose of Oral AP23573 in combination with Doxorubicin. Sarcoma patients 18 years of age and older are eligible. The treatment outline is not listed on the site. The total expected enrollment is 60 patients; the study started February 2006. The study is taking place at centers in California, Michigan, and Pennsylvania. For further details contact: Hanne Harbison 215-829-6712.
There are a large number of clinical trials that appear in the last issue of ESUN that are not listed above. We encourage you to explore them as well. Click here to do so.
V3N4 ESUN Copyright © 2006 Liddy Shriver Sarcoma Initiative.
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