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4'-Iodo-4'-Deoxydoxorubicin in Treating Patients With Primary Systemic Amyloidosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003853
Recruitment Status : Completed
First Posted : July 16, 2004
Last Update Posted : November 12, 2012
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Drug: 4'-iodo-4'-deoxydoxorubicin Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Primary Purpose: Treatment
Official Title: Phase II Trial of 4'-IODO-4'-Deoxydoxorubicin in Primary Amyloidosis (AL)
Study Start Date : April 1999
Actual Primary Completion Date : August 2000
Actual Study Completion Date : August 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis
Drug Information available for: Iodine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003853

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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
University of Pavia
Pavia, Italy, 27100
Sponsors and Collaborators
National Cancer Institute (NCI)
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Study Chair: Morie A. Gertz, MD Mayo Clinic
Publications of Results:
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Responsible Party: Morie Abraham Gertz, M.D., Mayo Clinic Identifier: NCT00003853    
Other Study ID Numbers: CDR0000067016
P30CA015083 ( U.S. NIH Grant/Contract )
988003 ( Other Identifier: Mayo Clinic Cancer Center )
T98-0003 ( Other Identifier: NCI Protocol )
302-99 ( Other Identifier: Mayo Clinic IRB )
First Posted: July 16, 2004    Key Record Dates
Last Update Posted: November 12, 2012
Last Verified: May 2011
Keywords provided by National Cancer Institute (NCI):
primary systemic amyloidosis
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Immunoglobulin Light-chain Amyloidosis
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Proteostasis Deficiencies
Metabolic Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents