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Annotations by
Tom Swartz
CCI-779 in Treating Patients With Soft Tissue Sarcoma or Gastrointestinal Stromal Tumor This Phase II trial is currently recruiting patients. The investigational drug CCI-779 (cell cycle inhibitor-779) belongs to a family of drugs called rapamycin analogs. It interacts with mTOR and inhibits its kinase activity ultimately decreasing the translation of mRNAs involved in the control of the cell cycle, resulting in cell cycle arrest. The purpose of this trial is to study how well CCI-779 works in treating patients with soft tissue sarcoma or gastrointestinal stromal tumor. Patients diagnosed with soft tissue of sarcoma or gastrointestinal stromal tumor 18 years of age are eligible. Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years. A total of 20-55 patients will be accrued for this study within 4-10 months. This trial is being conducted at centers in Maryland, Michigan, Missouri, Wisconsin, and the District of Columbia.
Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma This Phase II trial is currently recruiting patients. Gefitinib, or IRESSA as it is more commonly called, belongs to a group of anticancer drugs called epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKI). Gefitinib blocks growth signals in cancer cells. These signals are caused by an enzyme called tyrosine kinase. Gefitinib blocks several of these tyrosine kinases, including one associated with Epidermal Growth Factor Receptor (EGFR). EGFR is found on the cell surface of many normal cells and cancer cells. IRESSA works by binding to the tyrosine kinase of the EGFR to directly block growth signals turned on by triggers outside or inside the cell. The purpose of this trial is to study the effectiveness of gefitinib in treating patients who have locally advanced or metastatic synovial sarcoma. Patients receive oral gefitinib twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. A total of 14-44 patients will be accrued for this study within 18 months. Patients 18 years of age and older are eligible. This trial is taking place at centers in Belgium, France, the Netherlands, and the United Kingdom.
This Phase II trial is currently recruiting patients. Thalidomide may stop the growth of soft tissue sarcoma by stopping blood flow to the tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as doxorubicin, ifosfamide, and dacarbazine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving thalidomide together with radiation therapy and/or chemotherapy before surgery may shrink the tumor so that it can be removed. Thus, the purpose of this trial is to study how well giving preoperative (before surgery) thalidomide together with radiation therapy works in treating patients with low-grade primary soft tissue sarcoma, and how well giving thalidomide together with radiation therapy, doxorubicin, ifosfamide, and dacarbazine works in treating patients with high-grade or intermediate-grade primary soft tissue sarcoma of the arm, leg, chest wall, or abdominal wall. Patients with a diagnosis of primary soft tissue sarcoma 16 years of age and older are eligible. Patients with high- or intermediate-grade tumors ≥ 8 cm in diameter are assigned to cohort A and patients with low-grade tumors > 5 cm in diameter are assigned to cohort B. The treatment outline is as follows:
A total of 44 patients (22 per cohort) will be accrued for this study within 17 months. This trial is being conducted at centers in Indiana, Louisiana, Ohio, and Pennsylvania.
Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors This Phase I trial is currently recruiting patients. Radiolabeled octreotide can locate tumor cells and deliver radioactive tumor-killing substances to them without harming normal cells. Thus, the purpose of this trial is to study the effectiveness of radiolabeled octreotide in treating children who have advanced or refractory solid tumors. This is a dose-escalation study. Patients receive yttrium Y 90-DOTA-tyr3-octreotide IV over 5-10 minutes on day 1. Treatment repeats every 6 weeks for up to 3 courses in the absence of unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of yttrium Y 90-DOTA-tyr3-octreotide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Patients are followed weekly after each treatment course, 6 weeks after the last course, and then every 6 months thereafter for life. Approximately 25-35 patients will be accrued for this study. Patients age 2 to 25 years old are eligible. This trial is taking place at the Holden Comprehensive Cancer Center at the University of Iowa, Iowa City, Iowa.
Gemcitabine and Docetaxel to Treat Bone and Soft Tissue Cancers This Phase II trial is currently recruiting patients. This study will examine the side effects and possible benefits of the anti-cancer drugs gemcitabine (Gemzar) and docetaxel (Taxere) in patients with bone or soft tissue cancer (sarcoma); determine how the body absorbs and eliminates the drugs; and perform genetic studies on the tumor and try to grow the tumor in the laboratory or in animals. Patients 10 years of age and older with recurrent osteosarcoma, Ewing's sarcoma, and inoperable or recurrent inoperable chondrosarcoma may be eligible for this study. Participants receive gemcitabine and docetaxel in 21-day cycles as follows:
Treatment will continue for a total of 14 cycles or until the patient's tumor gets larger, side effects are unacceptable, the patient decides to stop treatment, or further treatment would not be in the patient's best interest. The total expected enrollment is 20 patients. Patients 4 years of age and older are eligible. This trial is taking place at the National Cancer Institute, Bethesda, Maryland.
BMS-247550 to Treat Children with Solid Tumors This Phase I trial is currently recruiting patients. This study will determine the highest dose of the experimental anticancer drug BMS-247550 that can be given safely to children. BMS-247550 belongs to a class of drugs called epothilones. These drugs are similar to another class called taxanes, which includes paclitaxel (Taxol) and docetaxel (Taxotere). The epothilones are able to kill cancer cells that are resistant to Taxol. Children 2 to 18 years of age and older with solid tumor cancers that do not respond to standard therapy may be eligible for this study. Cancers may include rhabdomyosarcoma and other soft tissue sarcomas, Ewing's sarcoma tumors, osteosarcoma, neuroblastoma, Wilms' tumor, liver tumors, germ cell tumors, brain tumors, and others. Participants will receive BMS-247550 intravenously (through a vein) over a 60-minute period for 5 consecutive days in 21- to 28-day cycles (i.e., 5 days of drug treatment followed by 15 to 22 days without drug, depending on the amount of time needed to recover from the drug side effects). The drug dose will be increased in successive small groups of patients, if the side effects at the previous dose are acceptable, until the optimum dose is achieved. Patients may continue treatment indefinitely unless their cancer worsens or they develop side effects that persist for more than 2 weeks. The total expected enrollment is 30 patients. Patients 2 to 18 years of age are eligible. This trial is taking place at the National Cancer Institute, Bethesda, Maryland.
This Phase II trial is currently recruiting patients. The purpose of this trial is to study how well oxaliplatin works in treating young patients with recurrent solid tumors, including sarcomas that have not responded to previous treatment. Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity. A total of 180 patients will be accrued for this study. Patients up to 21 years of age are eligible. This trial is taking place at centers in many states, as well as in the countries of Australia, Canada, the Netherlands, New Zealand, and Switzerland.
Inhalation SLIT Cisplatin for the Treatment of Osteosarcoma Metastatic to the Lung This PhaseI/II trial is currently recruiting patients. The purpose of this trial 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. 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. Patients will receive SLIT Cisplatin by inhalation for a 14-day treatment cycle in this phase Ib/IIa, two-center, open-label, study designed to characterize the maximum tolerated dose. 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. The total expected enrollment is 21 patients. Patients 13 to 50 years of age are eligible. This trial is taking place at The Albert Einstein College of Medicine Montefiore Medical Center, and Memorial Sloan Kettering Cancer Center, New York, NY.
This Phase I trial is currently recruiting patients. Flavopiridol may help the drug doxorubicin work better by making tumor cells more sensitive to the drug. The purpose of this trial is to study the side effects and best dose of flavopiridol when given with doxorubicin in treating patients with metastatic or recurrent sarcoma that cannot be removed by surgery. Patients 18 years of age and older with sarcoma or gastrointestinal stromal tumor are eligible. Patients receive doxorubicin IV over 5-10 minutes and flavopiridol IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients reaching a cumulative doxorubicin dose of 600 mg/m^2 or experiencing cardiotoxicity may receive flavopiridol alone at the discretion of the investigator. Cohorts of 3-6 patients receive escalating doses of flavopiridol 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. Ten additional patients receive treatment at the MTD. Patients are followed every 3 months for 1 year. A total of 3-36 patients will be accrued for this study within 1-2 years. This trial is taking place at Memorial Sloan-Kettering Cancer Center, New York, NY.
V2N3 ESUN Copyright © 2005 Liddy Shriver Sarcoma Initiative.
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