|
A Phase II study of PI-88 in Patients with Advanced Melanoma Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on A Phase II study of PI-88 in Patients with Advanced Melanoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Phase II study of PI-88 in Patients with Advanced Melanoma Clinical research trials and A Phase II study of PI-88 in Patients with Advanced Melanoma healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like A Phase II study of PI-88 in Patients with Advanced Melanoma. A Phase II study of PI-88 in Patients with Advanced Melanoma Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Phase II study of PI-88 in Patients with Advanced Melanoma clinical trial. Human subjects often obtain the finest healthcare possible for their A Phase II study of PI-88 in Patients with Advanced Melanoma condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Phase II study of PI-88 in Patients with Advanced Melanoma  A Phase II study of PI-88 in Patients with Advanced Melanoma
A Phase II study of PI-88 in Patients with Advanced Melanoma
For Condition: Melanoma
Status: Recruiting
Sponsor(s): Progen Industries Limited ,
Synopsis: The purpose of this study is to determine whether PI-88 is safe and effective in the treatment of advanced melanoma.
Details: PI-88 is an investigational drug that works by a novel mechanism which may reduce the rate of growth of tumors, and also the spread of cancer cells around the body. It also has an effect upon blood clotting. The purpose of this study is to assess if PI-88 has any benefit to patients with advanced melanoma, as well as to gain further information on the safety of the drug. All patients in the study will receive the study drug at the same dose level. The dose of PI-88 that will be given is based on the dose that was found to be the best in the phase I portion of this study. The drug will be injected subcutaneously (under the skin) once daily for 4 days every week. Patients will be treated with PI-88 for up to 6 months, but if the drug is well tolerated and effective, patients may be offered further treatment with the drug.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Current diagnosis of metastatic melanoma, where other effective therapy is not available or has failed. - Measurable disease. Metastatic lesions must be measurable by MRI or CT, and cutaneous lesions by physical examination. - Aged at least 18 years. - Have voluntarily given written informed consent to participate in this study. - Performance status: ECOG 0 - 2 (Karnofsky 70 -100%) - Life expectancy of at least 3 months. - Neutrophil count greater than 1.5 x 109/L (1,500/mm3) - Calculated creatinine clearance, using the Cockcroft-Gault formula, greater than 60 mL/min. If just below 60 mL/min, then GFR greater than 60 mL/min as determined by EDTA or DTPA scan. - Platelet count at least 100 x 109/L (100,000/mm3) - Bilirubin less than 1.5 x ULN - AST and ALT up to 2 x ULN, except in the presence of liver metastases; up to 5 x ULN. - Prothrombin time less than 1.5 x ULN - APTT normal (20 - 34 sec) Exclusion Criteria: - History of allergy and/or hypersensitivity to anti-coagulants/thrombolytic agents, especially heparin. - Chemotherapy, investigational or hormonal therapy in the previous 4 weeks. - Radiotherapy to a major bone marrow bearing area such as pelvis, femoral heads, lumbar-sacral spine, within the previous 4 weeks. Radiotherapy to other sites within the past 2 weeks. - Uncontrolled infection or serious infection within the past 4 weeks. - Clinically significant non-malignant disease. - Known HIV infection or AIDS-related illness. - Myocardial infarction, stroke or congestive heart failure within the past 3 months. - Current symptomatic central nervous system involvement, or active brain or meningeal metastases. - Pregnancy, breast feeding, or women of childbearing potential in whom pregnancy cannot be excluded. - History of abuse of alcohol, drugs, or other substances. - History of acute or chronic gastrointestinal bleeding within the last two years, inflammatory bowel disease, any other abnormal bleeding tendency, or patients at risk of bleeding due to open wounds or planned surgery. - Concomitant use of aspirin (more than 100 mg/day), non-steroidal anti-inflammatory drugs (except COX-2 Inhibitors), heparin, low molecular weight heparin or warfarin (more than 1 mg/day) is ongoing or anticipated during the study period. Low-dose aspirin (up to 100 mg/day) or low-dose warfarin (up to 1 mg/day) is permissible. - Heparin or low molecular weight heparin within the previous 2 weeks. - Not recovered from major surgery if conducted prior to the study. - History of heparin-induced thrombocytopenia, immune mediated thrombocytopenia, thrombotic thrombocytopenic purpura or other platelet disease, or laboratory evidence of anti-heparin antibodies.
Total Enrollment: 88
Location and Contact Information:
University of Colorado Health Sciences Center *Recruiting*
Aurora, Colorado, 80010-05801
United States
Recruiting Rene Gonzalez 720-848-0581
Additional Information:
Study ID Numbers: PR88201; PR88201A
Study Start Date: July 2001
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068172
Other Melanoma Studies:
1. Immunotherapy with Autologous Dexosomes for Patients with Stage IV Melanoma
2. Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer
3. Immunotherapy After Surgery in Treating Patients With Breast Cancer, Colon Cancer, or Melanoma
4. Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects with Metastatic Malignant Melanoma
5. Pilot Study of a Double Isolation Perfusion Schedule Using Melphalan Alone for Intransit Melanoma or Unresectable Sarcoma of the Extremity
Related Studies:
Other Melanoma Clinical Trials
Other Colorado Clinical Trials
Other Aurora Clinical Trials
A Phase II study of PI-88 in Patients with Advanced Melanoma
|
|
|
|
|
|
|
|
