Iododoxorubicin in Treating Patients With Primary Systemic Amyloidosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00030381
• Date of registration: 14/02/2002
• Prospective Registration: No
• Primary sponsor: National Cancer Institute (NCI)
• Public title: Iododoxorubicin in Treating Patients With Primary Systemic Amyloidosis
• Scientific title: Phase I Trial of 4'-IODO-4'-Deoxydoxorubicin in Primary Amyloidosis (AL)
• Date of first enrolment: December 2001
• Target sample size: 22
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00030381
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Angela Dispenzieri
• Affiliation: Mayo Clinic

Key inclusion & exclusion criteria

Inclusion Criteria:

- Histochemically confirmed amyloidosis by polarizing microscopy of greenbirefringent
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

- Performance status - ECOG 0-3 (3 allowed only if related to muscular infiltration by
amyloid or peripheral neuropathy)

- Platelet count at least 100,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Total bilirubin no greater than 2.0 mg/dL

- 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

- Creatinine clearance at least 40 mL/min

- 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

- 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

- More than 4 weeks since prior interferon alfa

- No concurrent immunotherapy

- More than 4 weeks since prior melphalan or other alkylating agents

- No prior anthracycline exposure greater than 120 mg/m^2

- Recovered from prior chemotherapy

- No other concurrent chemotherapy

- More than 4 weeks since prior high-dose dexamethasone

- No concurrent radiotherapy

- No concurrent investigational ancillary therapy



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Primary Systemic Amyloidosis

Intervention(s)

Other: pharmacological study

Drug: 4'-iodo-4'-deoxydoxorubicin

Primary Outcome(s)

MTD of IDOX defined as the highest safely-tolerated dose where =< 1 patient experiences DLT with the next higher dose having at least 2 patients who experience DLT [Time Frame: 12 weeks]

Secondary Outcome(s)

Laboratory correlates [Time Frame: Up to 3 months post treatment]

Secondary ID(s)

CDR0000069160

MC0113

NCI-2012-02443

U01CA069912

Source(s) of Monetary Support

Please refer to primary and secondary sponsors