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Hyperthermic Isolated Limb Perfusion and Melphalan with or without Tumor Necrosis Factor to Treat Advanced Melanoma in a Limb Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Hyperthermic Isolated Limb Perfusion and Melphalan with or without Tumor Necrosis Factor to Treat Advanced Melanoma in a Limb conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Hyperthermic Isolated Limb Perfusion and Melphalan with or without Tumor Necrosis Factor to Treat Advanced Melanoma in a Limb Clinical research trials and Hyperthermic Isolated Limb Perfusion and Melphalan with or without Tumor Necrosis Factor to Treat Advanced Melanoma in a Limb healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Hyperthermic Isolated Limb Perfusion and Melphalan with or without Tumor Necrosis Factor to Treat Advanced Melanoma in a Limb. Hyperthermic Isolated Limb Perfusion and Melphalan with or without Tumor Necrosis Factor to Treat Advanced Melanoma in a Limb Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Hyperthermic Isolated Limb Perfusion and Melphalan with or without Tumor Necrosis Factor to Treat Advanced Melanoma in a Limb clinical trial. Subjects frequently obtain the most expert healthcare possible for their Hyperthermic Isolated Limb Perfusion and Melphalan with or without Tumor Necrosis Factor to Treat Advanced Melanoma in a Limb condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "H" Clinical Trials Conditions > Hyperthermic Isolated Limb Perfusion and Melphalan with or without Tumor Necrosis Factor to Treat Advanced Melanoma in a Limb  Hyperthermic Isolated Limb Perfusion and Melphalan with or without Tumor Necrosis Factor to Treat Advanced Melanoma in a Limb
Hyperthermic Isolated Limb Perfusion and Melphalan with or without Tumor Necrosis Factor to Treat Advanced Melanoma in a Limb
For Condition: Malignant Melanoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study, conducted by the American College of Surgeons Oncology Group, will examine the safety and effectiveness of adding tumor necrosis factor (TNF) to a regimen of hyperthermic isolated limb perfusion (ILP) plus chemotherapy for treating melanoma in an arm or leg. With ILP, chemotherapy is given in high concentrations directly into the main blood vessels supplying the affected limb. The drugs circulate through the blood vessels for a short time and are then flushed out of the body. Before giving the drugs, the blood in the limb is heated in a process called hyperthermia to enhance the drugs' effectiveness. The anti-cancer drug melphalan is used in standard hyperthermic ILP treatment. This study will see if adding TNF to the treatment regimen can enhance tumor shrinkage and prolong disease remission. It will also compare the side effects and long-term effects of the two treatments. Patients 18 years of age or older with advanced melanoma in an arm or leg may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood and urine tests, chest x-ray, electrocardiogram, tumor biopsy, Computed Tomography (CT) imaging scans of the chest, abdomen, pelvis and brain, and a magnetic resonance imaging (MRI) scan of the brain. Whole body scans will be done, if needed. These tests will be done within 90 days of starting treatment. Participants will be randomly assigned to one of two treatment groups. Group 1 will receive ILP with hyperthermia using melphalan. Group 2 will receive ILP with hyperthermia using melphalan and TNF. All participants will receive hyperthermia under general anesthesia in the operating room. Tubes will be inserted into a vein in the neck or under the collarbone and then into blood vessels leading to the affected limb. A machine like the one used in open-heart surgery will circulate the blood and the drugs through these tubes during the procedure. A tourniquet will be placed on the limb to keep the drugs from entering the blood supply to the rest of the body. The blood from the limb will be heated to 102(Infinite) F to 105(Infinite) F (about the temperature of a hot tub) while it circulates through the machine. A radioactive chemical will be put in the blood to see how much of the drugs get into the blood supply and if any drug leaks to the rest of the body. In patients with melanoma in the leg, the lymph nodes in the groin will be removed if the cancer has spread to those nodes. In patients with melanoma in an arm, lymph nodes in the armpit will be removed whether or not they appear to contain cancer cells. Patients' heart and blood pressure will be monitored closely for 1 to 2 days, and total hospitalization time will be 4 to 8 days. In addition to treatment, patients will undergo the following tests before ILP and at various intervals after the procedure: - Measurements, photographs and biopsies of tumor deposits in the affected limb; - Ultrasound, CT scan or MRI of the affected limb for measurement of deep-lying tumors; - Referral to cardiologist for examination and tests, as needed, in patients 40 years old or older; - Pregnancy test for women of child-bearing potential. If needed, patients will have ultrasound of the limb within a few days after treatment to look for blood clots. Patients receiving TNF will have blood samples collected from the affected limb before and after TNF is given to measure TNF blood levels. Patients will be followed for the rest of their life to determine long-term effects of the study procedures.
Details: This is a multi-institutional trial coordinated by the University of Pennsylavania. Patients with metastatic melanoma of the limb will be randomized to receive hyperthermic isolated limb perfusion (ILP) with melphalan alone or melphalan and tumor necrosis factor (TNF). Randomization will be stratified for disease burden and prior ILP. The primary objective of this trial is to test the effect of adding TNF to melphalan via ILP for metastatic melanoma of the limb. It is projected that melphalan alone will achieve, at best, a 25% CR proportion while the addition of TNF will raise CR proportion to at least 55% among high tumor burden and prior limb perfused patients.
Eligibility:
Study Type: Interventional, Treatment, Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: A patient will be eligibile for inclusion in this study only if all of the following crirteria apply: 1. Patient must be greater than or equal to 18 years of age. 2. Patient must have an ECOG/Zubrod Performance status less than or equal to 2. 3. Patient must have biopsy proven melanoma of an extremity with: a. One or more evaluable in-transit metastases, indicating advanced local disease, OR b. Advanced primary lesions without local resection options short of amputation with all disease within the perfusion field of the extremity, OR c. Advanced primary lesions without local resection options short of amputation with disease outside of the perfusion field, provided each of the following criteria are met: (a) the tumor burden in the extremity is considered high, specifically there are either more than ten lesions or any single lesion is greater than 3 cm; (b) the patient has symptoms of pain, edema, skin breakdown, or decreased mobility due to the extremity tumor; (c) greater than 80 % of known tumor is within the extremity perfusion field; (d) the patient has an estimated life expectancy of greater than 6 months. (e) there is no evidence of brain metastases. 4. Patient with prior prophylactic ILP must have a disease-free interval of at least six months after ILP with melphalan or a disease-free interval of three months after ILP with an agent other than melphalan prior to registration. 5. Patient with prior therapeutic ILP must have: a. Partial response of at least three months duration prior to registration when prior ILP was performed for therapeutic reasons and melphalan was used. b. Stable response or disease progression when the prior ILP was performed at least three months prior to registration and melphalan was not used. 6. Patients must have at least one nodule in the extremity that is bi-dimensionally measurable. 7. Patient must have adequate bone marrow, hepatic and renal function, within 30 days prior to registration: a. Platelet greater than or equal to 100,000/mm(3) b. WBC greater than 2.5 X 10(9)/L c. Hgb greater than 9 g/dL d. Serum creatinine less than 1.5 mg/dL or creatinine clearance greater than 50 ml/minute e. SGOT (AST) less than 2 times the institution ULN f. SGPT (ALT) less than 2 times the institution ULN g. Alkaline phosphotase less than 2 times the institution ULN h. Total bilirubin less than1.25 times the institution ULN i. Calcium less than 12 mg/dL j. Coagulation studies less than or within 1 second of the upper limit of institutional normal 8. Female patient of childbearing potential must have negative serum pregnancy test within 2 days prior to registration. NOTE: Melphalan is an alkylating agent with mutagenic and teratogenic effects. 9. Patient or the patient's legally acceptable representative must sign and date informed consent PRIOR to registration and any study related procedures being performed. 10. If patient is a survivor of a prior cancer, all of the following criteria must be met: a. Patient has undergone potentially curative therapy for all prior malignancies, b. No evidence of any prior malignancies other than the melanoma for at least five years, and c. Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies (other than melanoma). EXCLUSION CRITERIA: A patient will NOT be eligible for inclusion in this study if any of the following criteria apply: 1. Patient has received chemotherapy, radiotherapy or biologic therapy within 30 days prior to registration. 2. Patient had prior ILP with melphalan alone and the response was stable or progressive disease. 3. Patient has melphalan hypersensitivity. 4. Patient has hypersensitivity to any component of the TNF - alpha formulation. 5. Patient has: Unstable Angina Uncontrolled or life threatening cardiac arrythmia A myocardial infarct, coronary artery surgery, or angioplasty' within 1 year prior to registration. Congestive Heart Failure (NYHA Class II, III, IV) 6. Patient has evidence of severe peripheral vascular disease. NOTE: Specifically patients with any history of claudication or another ischemic peripheral vascular disease (e.g., venous thrombosis or occlusive peripheral arterial disease). 7. Patient has a history of symptomatic cerebral or carotid artery disease. 8. Patient has had pulmonary embolism within 1 year prior to registration. 9. Patient has had active peptic ulcer disease within 1 year prior to registration. 10. Patient has concurrent infections, not controlled by antibiotics. 11. Patient has contraindications to the use of ionotropic agents (e.g., dopamine, neosynepherine) 12. Patient is breast feeding. NOTE: It is not known whether TNF is excreted in human milk. Because of the unknown risk to the infant, breastfeeding is contraindicated within 7 days of ILP. 13. Patient has known HIV. NOTE: rh TNF-alpha is an immunoactive agent that may be affected by HIV disease.
Total Enrollment: 40
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 030137; 03-C-0137
Study Start Date: March 19, 2003
Record last reviewed: March 3, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00056732
Other Malignant Melanoma Studies:
1. Study of Heat Shock Protein-Peptide Complex (HSPPC-96) versus IL-2/DTIC for Stage IV Melanoma
2. Vaccine Therapy for Patients with Stage III Melanoma
3. Phase I Study of gp75 Vaccine in Patients with Stage III and IV Melanoma
4. Vaccine Therapy for Patients with Stage IV Melanoma
5. Phase II Trial of Allovectin-7® for Metastatic Melanoma
Related Studies:
Other Malignant Melanoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Hyperthermic Isolated Limb Perfusion and Melphalan with or without Tumor Necrosis Factor to Treat Advanced Melanoma in a Limb
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