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PI-88 in Treating Patients With an Advanced Malignancy (Cancer) or Stage IV Melanoma 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 PI-88 in Treating Patients With an Advanced Malignancy (Cancer) or Stage IV Melanoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. PI-88 in Treating Patients With an Advanced Malignancy (Cancer) or Stage IV Melanoma Clinical research trials and PI-88 in Treating Patients With an Advanced Malignancy (Cancer) or Stage IV Melanoma 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 PI-88 in Treating Patients With an Advanced Malignancy (Cancer) or Stage IV Melanoma. PI-88 in Treating Patients With an Advanced Malignancy (Cancer) or Stage IV Melanoma 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 PI-88 in Treating Patients With an Advanced Malignancy (Cancer) or Stage IV Melanoma clinical trial. Subjects frequently obtain the most expert healthcare possible for their PI-88 in Treating Patients With an Advanced Malignancy (Cancer) or Stage IV Melanoma 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 > "P" Clinical Trials Conditions > PI-88 in Treating Patients With an Advanced Malignancy (Cancer) or Stage IV Melanoma  PI-88 in Treating Patients With an Advanced Malignancy (Cancer) or Stage IV Melanoma
PI-88 in Treating Patients With an Advanced Malignancy (Cancer) or Stage IV Melanoma
For Condition: Recurrent Melanoma,Stage 4 Melanoma,unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Progen Industries Limited ,
Synopsis: RATIONALE: PI-88 may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase I/II trial to study the effectiveness of PI-88 in treating patients who have an advanced malignancy (cancer) or stage IV melanoma.
Details: OBJECTIVES: Phase I - Determine the maximum tolerated dose of PI-88 in patients with an advanced malignancy. - Determine the safety and tolerability of this drug in these patients. Phase II - Determine the progression-free survival and time to progression in patients with stage IV melanoma treated with this drug. - Determine the biological activity of this drug in these patients. OUTLINE: This is an open-label, dose-escalation study. - Patients receive PI-88 subcutaneously (SC) once daily on days 1-4 and 15-18. Cohorts of 3-6 patients receive escalating doses of PI-88 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. Once the MTD has been determined in part I, the effect of dose frequency is determined in patients in part II. - Patients receive PI-88 SC once daily on days 1-4, 8-11, 15-18, and 22-25 at a dose based on the MTD determined in part 1. Cohorts of 3 patients receive escalating doses of PI-88 until the MTD at this frequency is determined. - Phase II (patients with metastatic melanoma): Patients receive PI-88 as in phase I, part 2 at the MTD. Treatment in both phases repeats every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 18-69 patients (18-30 for phase I [part 1], 6-9 for phase I [part 2], and 25-30 for phase II) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: Phase I - Histologically or cytologically confirmed malignancy - No other effective treatment available OR failed prior therapy - No prior or concurrent symptomatic or known CNS involvement or brain or meningeal metastases Phase II - Diagnosis of stage IV melanoma - Metastatic disease must be measurable - No other effective treatment available OR failed prior therapy - Asymptomatic brain metastases allowed provided patient is off steroids PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 70-100% Life expectancy - At least 3 months Hematopoietic - Neutrophil count greater than 1,500/mm^3 - Platelet count greater than 100,000/mm^3 - Negative serotonin release assay test for anti-heparin antibodies - No other abnormal bleeding tendency - No history of heparin-induced thrombocytopenia - No history of immune-mediated thrombocytopenia - No history of thrombolytic thrombocytopenic purpura - No history of other platelet disease Hepatic - Bilirubin less than 1.5 times upper limit of normal (ULN) - AST and ALT no greater than 2 times ULN (5 times ULN if liver metastases are present) - PTT normal (20-34 sec) - PT less than 1.5 times ULN Renal - Creatinine clearance greater than 60 mL/min OR - Glomerular filtration rate greater than 60 mL/min Cardiovascular - No myocardial infarction within the past 3 months - No stroke within the past 3 months - No congestive heart failure within the past 3 months Gastrointestinal - No history of acute or chronic gastrointestinal bleeding within the past 2 years - No inflammatory bowel disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No AIDS-related illness - No serious infection within the past 4 weeks - No history of alcohol, drug, or other substance abuse - No history of allergy and/or hypersensitivity to anti-coagulants/thrombolytic agents (e.g., heparin) - No risk of bleeding due to open wounds or planned surgery - No clinically significant nonmalignant disease - No uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - More than 4 weeks since prior chemotherapy Endocrine therapy - More than 4 weeks since prior hormonal therapy Radiotherapy - More than 2 weeks since prior radiotherapy - More than 4 weeks since prior radiotherapy to a major bone-marrow bearing area (e.g., pelvis, femoral heads, or lumbar-sacral spine) - Concurrent palliative radiotherapy allowed Surgery - Recovered from prior major surgery - No concurrent surgery Other - More than 2 weeks since prior heparin or low-molecular weight heparin - More than 4 weeks since other prior investigational therapy - No other concurrent investigational drugs - No other concurrent antineoplastic therapy - No concurrent aspirin or aspirin-containing medications - No concurrent nonsteroidal anti-inflammatory drugs - Concurrent cyclooxygenase-2 inhibitors allowed - No concurrent heparin or low-molecular weight heparin - No concurrent warfarin or warfarin-containing medications - No other concurrent anticoagulant medications
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ReneGonzalez, Principal Investigator, University of Colorado Cancer Center
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Aurora, Colorado, 80010
United States
Recruiting Rene Gonzalez 720-848-0564
Additional Information:
Study ID Numbers: CDR0000335412; COMIRB-01-207,PROGEN-PR88201
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00073892
Other Recurrent Melanoma Studies:
1. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Metastatic Kidney Cancer
2. Interferon gamma in Treating Patients With Recurrent or Metastatic Melanoma or Other Solid Tumors
3. Interleukin-12 and Interferon alfa in Treating Patients With Metastatic Malignant Melanoma
4. Flavopiridol Plus Cisplatin or Carboplatin in Treating Patients With Advanced Solid Tumors
5. Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma
Related Studies:
Other Recurrent Melanoma Clinical Trials
Other Colorado Clinical Trials
Other Aurora Clinical Trials
PI-88 in Treating Patients With an Advanced Malignancy (Cancer) or Stage IV Melanoma
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