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Iododoxorubicin in Treating Patients With Primary Systemic Amyloidosis Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Iododoxorubicin in Treating Patients With Primary Systemic Amyloidosis conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Iododoxorubicin in Treating Patients With Primary Systemic Amyloidosis Clinical research trials and Iododoxorubicin in Treating Patients With Primary Systemic Amyloidosis medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Iododoxorubicin in Treating Patients With Primary Systemic Amyloidosis. Iododoxorubicin in Treating Patients With Primary Systemic Amyloidosis Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Iododoxorubicin in Treating Patients With Primary Systemic Amyloidosis clinical trial. Participants oftentimes recieve the finest healthcare available for their Iododoxorubicin in Treating Patients With Primary Systemic Amyloidosis condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Iododoxorubicin in Treating Patients With Primary Systemic Amyloidosis  Iododoxorubicin in Treating Patients With Primary Systemic Amyloidosis
Iododoxorubicin in Treating Patients With Primary Systemic Amyloidosis
For Condition: primary systemic amyloidosis
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Mayo Clinic Cancer Center
Synopsis: RATIONALE: Iododoxorubicin may dissolve protein deposits and be an effective treatment for primary systemic amyloidosis. PURPOSE: Phase I trial to determine the effectiveness of iododoxorubicin in treating patients who have primary systemic amyloidosis.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of iododoxorubicin in patients with primary systemic amyloidosis. II. Determine the safety, especially cardiac safety, of this drug in these patients. III. Determine the survival rate of patients treated with this drug. IV. Determine, preliminarily, the clinical efficacy of this drug in these patients. V. Determine the pharmacokinetics of this drug in these patients. PROTOCOL OUTLINE: This is a dose-escalation study. Patients receive iododoxorubicin IV over 15 minutes on days 1, 8, 15, and 22. Treatment repeats every 12 weeks for a total of 4 courses or a cumulative dose of 400 mg/m2 in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of iododoxorubicin 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. Patients are followed every 6 months for 3 years. PROJECTED ACCRUAL: A total of 9-22 patients will be accrued for this study within 12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histochemically confirmed amyloidosis by polarizing microscopy of green birefringent material in Congo red-stained tissue specimens - At least one of the following: Demonstrable M-protein in serum or urine; Clonal population of plasma cells in bone marrow; Immunohistochemical stain with anti-light chain antisera of amyloid fibrils - Symptomatic organ involvement, including liver involvement, mild cardiac involvement, renal involvement, grade 1 or 2 peripheral neuropathy, or soft tissue involvement (including tongue); No purpura or carpal tunnel syndrome as sole manifestation of disease - No clinically overt multiple myeloma defined as monoclonal bone marrow platelet concentration greater than 20% and at least one of the following: Bone lesions; Anemia; Hypercalcemia --Prior/Concurrent Therapy-- - Biologic therapy: More than 4 weeks since prior interferon alfa; No concurrent immunotherapy - Chemotherapy: More than 4 weeks since prior melphalan or other alkylating agents; No prior anthracycline exposure greater than 120 mg/m2; Recovered from prior chemotherapy; No other concurrent chemotherapy - Endocrine therapy: More than 4 weeks since prior high-dose dexamethasone - Radiotherapy: No concurrent radiotherapy - Surgery: Not specified - Other: No concurrent investigational ancillary therapy --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-3 (3 allowed only if related to muscular infiltration by amyloid or peripheral neuropathy) - Life expectancy: Not specified - Hematopoietic: Platelet count at least 100,000/mm3; Absolute neutrophil count at least 1,500/mm3 - Hepatic: Total bilirubin no greater than 2.0 mg/dL OR Direct bilirubin no greater than 1.0 mg/dL; Alkaline phosphatase no greater than 4 times upper limit of normal (ULN); AST or ALT no greater than 3 times ULN - Renal: Creatinine clearance at least 40 mL/min - Cardiovascular: Ejection fraction at least 50% by echocardiogram; No New York Heart Association class III or IV heart disease; No enzyme-documented myocardial infarction within the past 3 years; No chronic atrial fibrillation; No grade 2 or 3 atrioventricular block (Mobitz type I allowed); No sustained (greater than 30 seconds) ventricular tachycardia, more than 1 episode of non-sustained ventricular tachycardia (3 consecutive ventricular beats), or frequent (more than 20 in 24 hours) ventricular pairs by 24-hour ambulatory electrocardiographic monitoring; No intraventricular septum greater than 16 mm by echocardiogram - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No uncontrolled infection; No other active malignancy except nonmelanoma skin cancer or cervical cancer; No psychiatric illness or social situation that would preclude study; No severe diarrhea (greater than grade 3) that is not controllable with medication or that requires total parenteral nutrition
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AngelaDispenzieri, Study Chair, Mayo Clinic Cancer Center
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Additional Information:
Study ID Numbers: CDR0000069160; MAYO-MC0113,NCI-5718
Study Start Date: December 2001
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030381
Other Primary Systemic Amyloidosis Studies:
1. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients Who Have Multiple Myeloma or Primary Systemic Amyloidosis
2. Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation
3. Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
4. Dexamethasone Plus Interferon alfa in Treating Patients With Primary Systemic Amyloidosis
5. High-Dose Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Amyloidosis
Related Studies:
Other primary systemic amyloidosis Clinical Trials
Other Minnesota Clinical Trials
Other Rochester Clinical Trials
Iododoxorubicin in Treating Patients With Primary Systemic Amyloidosis
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