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Limb Perfusion of Melphalan, with or without Tumor Necrosis Factor, to Treat Inoperable Arm or Leg Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Limb Perfusion of Melphalan, with or without Tumor Necrosis Factor, to Treat Inoperable Arm or Leg Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Limb Perfusion of Melphalan, with or without Tumor Necrosis Factor, to Treat Inoperable Arm or Leg Cancer Clinical research trials and Limb Perfusion of Melphalan, with or without Tumor Necrosis Factor, to Treat Inoperable Arm or Leg Cancer medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Limb Perfusion of Melphalan, with or without Tumor Necrosis Factor, to Treat Inoperable Arm or Leg Cancer. Limb Perfusion of Melphalan, with or without Tumor Necrosis Factor, to Treat Inoperable Arm or Leg Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Limb Perfusion of Melphalan, with or without Tumor Necrosis Factor, to Treat Inoperable Arm or Leg Cancer clinical trial. Participants frequently get the best healthcare available for their Limb Perfusion of Melphalan, with or without Tumor Necrosis Factor, to Treat Inoperable Arm or Leg Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "L" Clinical Trials Conditions > Limb Perfusion of Melphalan, with or without Tumor Necrosis Factor, to Treat Inoperable Arm or Leg Cancer  Limb Perfusion of Melphalan, with or without Tumor Necrosis Factor, to Treat Inoperable Arm or Leg Cancer
Limb Perfusion of Melphalan, with or without Tumor Necrosis Factor, to Treat Inoperable Arm or Leg Cancer
For Condition: Sarcoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Using a technique called isolated limb perfusion, patients with inoperable arm or leg tumors will be given drug treatment directly into the blood vessels feeding the affected limb to try to destroy the tumor and avoid amputating the arm or leg. Large arm and leg tumors sometimes cannot be successfully operated on because they are too close to a vital structure, such as a major blood vessel, nerve or bone. In such cases, amputation is required in order to remove the entire tumor. In many patients, however, the cancer spreads even after amputation. Standard drug and radiation therapies have not been very successful in treating these large tumors. In a previous study of a small number of patients given the drugs melphalan and tumor necrosis factor via isolated limb perfusion, tumors in more than 65 percent of the patients shrank, allowing surgical removal without amputation. This study will evaluate this treatment in a larger number of patients. Patients will be randomly assigned to receive treatment with melphalan alone or melphalan with tumor necrosis factor. Isolated limb perfusion is a major operation, done under general anesthesia. In this procedure, catheters (plastic tubes) are placed into the large blood vessels going to the arm or leg where the tumor is located. An external pump similar to that used in open-heart surgery circulates blood and medicines through the tubes and into the limb for 90 minutes. A tourniquet is placed around the arm or leg to confine the medicines to that limb-the very high doses of melphalan given through this perfusion method would not be safe if it reached all parts of the body in the normal blood circulation. The entire operation lasts between 4 and 5 hours. Patients will be in intensive care up to 2 days, and total hospitalization time will be between 10 and 14 days. Before and after the operation, patients will have magnetic resonance imaging studies to determine the size and blood flow of the tumor. If, from to 12 weeks after the limb perfusion the tumor has shrunk sufficiently, surgical removal, with or without additional radiation therapy, may be possible.
Details: Patients with unresectable high-grade extremity sarcoma will undergo a 90 minute hyperthermic isolated limb perfusion with melphalan. Patients will be randomized to receive or not receive tumor necrosis factor as part of the treatment regimen. Four to twelve weeks following perfusion patients will undergo definitive local therapy (excision with or without radiation therapy) if appropriate based upon the clinical setting. Patients will be followed for overall response, local and systemic recurrence-free survival and overall survival.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Histologically or cytologically proven measurable unresectable high-grade extremity sarcoma. Patients with metastatic disease who would benefit from palliative treatment of the primary tumor will be included. All disease must be distal to the apex of the femoral triangle in the lower limb and distal to the deltoid insertion in the upper limb. Patients must have no chemotherapy, radiotherapy or biological therapy for one month prior to the ILP and must have recovered from all side effects. Patients must have an ECOG performance status of 0, 1, or 2 on the day prior to treatment. Patients must be more than 30 kg because of inherent limitations in the size of the cannulae in the perfusion circuit, and at least 15 years of age. Patients must have a platelet count greater than 100,000 coagulation studies within 1 second of normal, a serum bilirubin less than 1.5, and a creatinine less than 2.0. Patients must be aware of the neoplastic nature of his/her illness, the experimental nature of the therapy, alternative treatments, potential benefits, and risks. The patient must be willing to sign an informed consent. Patients must be felt to have no local resection option by the consensus of staff surgeons and to require amputation or resection of major nerves or vascular structures to control disease. No pregnant patients or nursing mothers due to the unknown effects of TNF and melphalan or the stress of limb perfusion. No patients taking immunosuppressive drugs or on chronic anticoagulation who cannot be temporarily off treatment. No patients with active infections. No patients with HIV disease due to the unknown effects of the perfusion on the development of opportunistic infection. No patients who have had prior limb perfusion. No patients who have evidence of severe peripheral vascular disease, specifically patients with any history of claudication or any other ischemic peripheral vascular manifestations. No patients who have received prior melphalan therapy. No patients who have received 2 or more prior systemic regimens of chemotherapy. No newly diagnosed pediatric patients who have sarcomas that have curative potential with other chemotherapeutic regimens, i.e., newly diagnosed Ewing's sarcoma, Rhabdomyosarcoma, etc.
Total Enrollment: 40
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 990145; 99-C-0145
Study Start Date: August 2, 1999
Record last reviewed: March 19, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001831
Other Sarcoma Studies:
1. Magnetic-Targeted Doxorubicin in Treating Patients with Cancer Metastatic to the Liver
2. Temozolomide and O6-Benzylguanine for Treating Childhood Cancers
3. Evaluation, Treatment, and Natural History of Children with Cancer
4. The Role of Multi-Modality Therapy for the Treatment of High-Grade Soft Tissue Sarcomas of the Extremities
5. Pilot Study of a Double Isolation Perfusion Schedule Using Melphalan Alone for Intransit Melanoma or Unresectable Sarcoma of the Extremity
Related Studies:
Other Sarcoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Limb Perfusion of Melphalan, with or without Tumor Necrosis Factor, to Treat Inoperable Arm or Leg Cancer
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