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This Phase I clinical trial is currently recruiting patients. Its rationale centers on investigating vaccines. The investigators state, “Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may be effective in treating soft tissue sarcoma.” The drug sargramostim is also know as Leukine, Prokine, and GM-CSF and has been used in treating non-Hodgkins lymphomas and acute leukemia. Sargramostim is used to treat neutropenia, i.e., to increase the number of white blood cells when the white blood cell count is low.
High Dose Chemotherapy and Stem Cell Transplant A randomized trial for patients with metastatic Ewing’s sarcoma to determine if stem cell transplant is effective is currently underway in Europe and is also enrolling patients in the US. The Children’s Oncology Group (COG) is joining the EUROpean Ewing Tumor Working Initiative of National Groups (EURO-EWING99) study to find out if using high dose chemotherapy (megatherapy) and stem cell transplant is more effective than the standard chemotherapy and radiation therapy for treating metastatic patients. For more details see the European Organization for Research and Treatment of Cancer (EORTC) protocol 62981 and a description of this study in the Clinical Trial PDQ database that lists the extensive set of European and US study sites involved.
Antineoplaston Therapy in Treating Patients with Malignant Fibrous Histiocytoma (MFH) This Phase II clinical trial study is currently recruiting patients. It is focused on studying the effectiveness of antineoplaston therapy in treating patients who have malignant fibrous histiocytoma (MFH). Antineoplastons may inhibit the growth of cancer cells. Antineoplastons are naturally-occurring substances found in urine, but they can also be made in the laboratory.
Late Effects of Treatment for Sarcomas in Children This study, sponsored by the National Cancer Institute (NCI), is currently recruiting patients. It will examine some of the late effects of treatment for bone and soft tissue sarcoma in children. The abstract notes,, “Survival of patients with these diseases has improved over the years, but long-term adverse effects of treatment have also been noted.” In particular, the study will review the incidence and extent of the following late effects of therapy: heart problems, gonadal dysfunction, psychosocial problems, changes in bodily function and capabilities, exposure to viruses, kidney function and immune function.
Soblidotin in Treating Patients with Advanced or Metastatic Soft Tissue Sarcoma This Phase II clinical trial is currently treating patients. According to the abstract, it is intended to “to study the effectiveness of soblidotin in treating patients who have advanced or metastatic soft tissue sarcoma”. Soblidotin (also called TZT-1027) belongs to a family of drugs called “tubulin inhibitors”. According to a paper by Bacher et al, “Tubulin-containing structures are important for diverse cellular functions, including chromosome segregation during cell division, intracellular transport, development and maintenance of cell shape, cell motility, and possibly distribution of molecules on cell membranes.” Tubulin inhibitors attempt to stop tumor cells from dividing so the tumors stop growing or die.
Alanosine in Treating Patients with Cancer. The purpose of this Phase II clinical trial, which is currently recruiting patients, is to study the effectiveness of alanosine in treating patients who have soft tissue sarcoma, sarcoma of the bone, mesothelioma, non-small cell lung cancer, or pancreatic cancer. Alanosine, also called SDX-102, belongs to the family of drugs called antimetabolites. These drugs interfere with the body’s chemical processes, such as creating proteins, DNA, and other chemicals needed for cell growth and reproduction. When used in cancer treatment, these drugs disrupt DNA production, which in turn prevents cell division.
ET-743 in Pretreated Soft Tissue Sarcoma Patients The results of a “Phase II Study of Ecteinascidin-743 in Advanced Pretreated Soft Tissue Sarcoma Patients” were reported by A. Yovine, M. Riofrio, J. Y. Blay, E. Brain, J. Alexandre, C. Kahatt, A. Taamma, J. Jimeno, C. Martin, Y. Salhi, E. Cvitkovic, and J. L. Misset in the Journal of Clinical Oncology (March 2004; Vol. 22, No. 5, pp. 890-899). The purpose of this Phase II clinical trial was to evaluate the efficacy, safety, and pharmacokinetics of ecteinascidin-743 (ET-743) in pretreated advanced soft tissue sarcoma patients. Among the 54 patients, 41% had leiomyosarcoma (eight of 22 of uterine origin). The researchers concluded that “With a 4% overall response rate (95% CI, 0.5 to 12.8) and an 11% rate of third-party-verified tumor regression (overall response rate + minor response), ET-743 has a 24% 6-month disease progression control rate, confirming evidence of antitumoral activity and a manageable safety profile in patients experiencing disease progression with pretreated soft tissue sarcoma.”
V1N2 ESUN Copyright © 2004 Liddy Shriver Sarcoma Initiative
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