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

• Sponsor: National Cancer Institute (NCI)
• Information provided by: National Cancer Institute (NCI)

Tracking Information

• First Submitted Date: November 1, 1999
• First Posted Date: July 16, 2004
• Last Update Posted Date: November 12, 2012
• Study Start Date: April 1999
• Actual Primary Completion Date: August 2000 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Change History: Complete list of historical versions of study NCT00003853 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 4'-Iodo-4'-Deoxydoxorubicin in Treating Patients With Primary Systemic Amyloidosis
• Official Title: Phase II Trial of 4'-IODO-4'-Deoxydoxorubicin in Primary Amyloidosis (AL)

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.

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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Primary Purpose: Treatment
• Condition: Multiple Myeloma and Plasma Cell Neoplasm
• Intervention: Drug: 4'-iodo-4'-deoxydoxorubicin
• Study Arms: Not Provided
• Publications *: Gertz MA, Lacy MQ, Dispenzieri A, Cheson BD, Barlogie B, Kyle RA, Palladini G, Geyer SM, Merlini G. A multicenter phase II trial of 4'-iodo-4'deoxydoxorubicin (IDOX) in primary amyloidosis (AL). Amyloid. 2002 Mar;9(1):24-30.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: April 9, 2007): 45
• Original Enrollment: Not Provided
• Actual Study Completion Date: August 2001
• Actual Primary Completion Date: August 2000 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy, United States

Administrative Information

• NCT Number: 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 )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Morie Abraham Gertz, M.D., Mayo Clinic
• Study Sponsor: National Cancer Institute (NCI)
• Collaborators: Not Provided

Investigators

• Study Chair: Morie A. Gertz, MD; Mayo Clinic

• PRS Account: National Cancer Institute (NCI)
• Verification Date: May 2011