Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Projected Accrual
Outline
Published Results
Trial Contact Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI MAYO-988003 NCI-T98-0003

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.

Entry 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)

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

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

Projected Accrual

A total of 45 patients will be accrued for this study within 1 year.

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.

Disclaimer

The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

Gertz MA, Lacy MQ, Dispenzieri A, et al.: A multicenter phase II trial of 4'-iodo-4'deoxydoxorubicin (IDOX) in primary amyloidosis (AL). Amyloid 9 (1): 24-30, 2002.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Mayo Clinic Cancer Center

Morie Gertz, MD, Protocol chair		Ph: 507-284-2511

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