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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003853 |
RATIONALE: 4'-Iodo-4'-deoxydoxorubicin may improve organ dysfunction and ease symptoms caused by primary systemic amyloidosis.
PURPOSE: Phase II trial to study the effectiveness of 4'-iodo-4'-deoxydoxorubicin in treating patients who have primary systemic amyloidosis.
Condition | Intervention | Phase |
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Multiple Myeloma and Plasma Cell Neoplasm |
Drug: 4'-iodo-4'-deoxydoxorubicin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Trial of 4'-IODO-4'-Deoxydoxorubicin in Primary Amyloidosis (AL) |
Estimated Enrollment: | 45 |
Study Start Date: | April 1999 |
OBJECTIVES: I. Evaluate the clinical efficacy of 4'-iodo-4'-deoxydoxorubicin in producing palliation of symptoms and/or improvement of organ dysfunction caused by organ infiltration by amyloid in patients with primary systemic amyloidosis. II. Assess the safety profile, with emphasis on cardiac safety, of this drug in these patients. III.
Evaluate the time to progression of amyloidosis-associated clinical symptoms and/or organ dysfunction, duration of response, and survival of these patients on this regimen.
OUTLINE: Patients receive 4'-iodo-4'-deoxydoxorubicin IV over 1 hour once a week for 4 weeks. Courses are repeated every 12 weeks. Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histochemically proven primary systemic amyloidosis (AL) No presence of non-AL amyloidosis No amyloid-specific syndrome (e.g., skin purpura or carpal tunnel syndrome) as only evidence of disease No vascular amyloid only in a bone marrow biopsy specimen or in a plasmacytoma Must have symptomatic organ involvement with amyloid (e.g., liver, mild cardiac, renal, or soft tissue involvement, or grade 1 or 2 peripheral neuropathy) Demonstrable M-protein in the serum/urine OR Clonal population of plasma cells in the bone marrow OR Immunohistochemical stain with anti-light chain antisera of amyloid fibrils No clinically overt multiple myeloma (i.e., monoclonal BMPC greater than 20% and at least one of the following: bone lesions, anemia, or hypercalcemia)
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Total bilirubin less 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) ALT or AST no greater than 3 times ULN Renal: Creatinine clearance greater than 40 mL/min Cardiovascular: Echocardiographic ejection fraction greater than 50% At least 3 years since prior enzyme documented myocardial infarction Interventricular septal thickness no greater than 20 mm No New York Heart Association class III or IV heart failure No grade 2 or 3 A-V block No chronic atrial fibrillation No sustained (greater than 30 seconds) ventricular tachycardia or frequent episodes (greater than 20 in 24 hours) of nonsustained ventricular tachycardia or ventricular pairs, detected by 24-hour ambulatory electrocardiographic monitoring Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV positive allowed No uncontrolled infection No severe diarrhea not controllable with medication or that requires total parenteral nutrition No other concurrent active malignancy except nonmelanoma skin cancer or cervical cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior interferon alfa Chemotherapy: No prior anthracyclines greater than 120 mg/m2 At least 6 weeks since prior melphalan or other alkylating agents
Endocrine therapy: At least 6 weeks since prior high dose dexamethasone Radiotherapy: Not specified Surgery:
Not specified
United States, Arkansas | |
University of Arkansas for Medical Sciences | |
Little Rock, Arkansas, United States, 72205 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
Italy | |
University of Pavia | |
Pavia, Italy, 27100 |
Study Chair: | Morie A. Gertz, MD | Mayo Clinic |
Study ID Numbers: | CDR0000067016, MAYO-988003, NCI-T98-0003 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003853 History of Changes |
Health Authority: | United States: Federal Government |
primary systemic amyloidosis |
Metabolic Diseases Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Primary Amyloidosis Blood Coagulation Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders |
Doxorubicin Multiple Myeloma 4'-deoxydoxorubicin Anti-Bacterial Agents Amyloidosis Hemorrhagic Disorders Lymphoproliferative Disorders Metabolic Disorder Neoplasms, Plasma Cell |
Immunoproliferative Disorders Metabolic Diseases Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents Blood Protein Disorders Hematologic Diseases Vascular Diseases Paraproteinemias Antibiotics, Antineoplastic Hemostatic Disorders |
Pharmacologic Actions Doxorubicin Multiple Myeloma 4'-deoxydoxorubicin Amyloidosis Neoplasms Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |