Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation

• Status: Terminated
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Having a peripheral stem cell transplant to replace the blood-forming cells destroyed by chemotherapy, allows higher dose of chemotherapy to be given so that more plasma cells are killed. Giving a chemoprotective drug such as amifostine may protect kidney cells from the side effects of chemotherapy.

PURPOSE: This phase I trial is studying the side effects and best dose of melphalan given together with amifostine in treating patients who are undergoing peripheral stem cell transplant for primary systemic amyloidosis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Amifostine; Melphalan

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed amyloidosis

• No secondary familial or localized amyloidosis

• Presence of monoclonal protein by immunoelectrophoresis or immunofixation of serum or urine

• No primary amyloidosis manifested only by carpal tunnel syndrome or purpura

• Amyloid deposits in a plasmacytoma or in bone marrow vessels in an asymptomatic individual not considered an amyloid syndrome

• Amyloid syndromes include any of the following:

• Hepatomegaly

• Cardiomyopathy

• Nephrotic range proteinuria

• Peripheral or autonomic neuropathy

• No multiple myeloma defined by 1 of the following:

• Presence of lytic bone disease

• More than 30% bone marrow plasma cells

PATIENT CHARACTERISTICS:

Age

• 18 to 70

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

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

Hepatic

• See Disease Characteristics

• Total or direct bilirubin no greater than 2.0 mg/dL

• Alkaline phosphatase no greater than 4 times upper limit of normal

Renal

• See Disease Characteristics

• Creatinine less than 3.0 mg/dL

Cardiovascular

• See Disease Characteristics

• Ejection fraction at least 45% by echocardiogram

• No New York Heart Association class III or IV heart disease

• Systolic blood pressure ≥ 90 mmHg

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No active infection

• No other malignancy within the past 5 years except surgically treated carcinoma in situ of the cervix, nonmelanoma skin cancer, or indolent prostate cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

• At least 4 weeks since prior interferon

Chemotherapy

• At least 4 weeks since prior melphalan

• Lifetime total melphalan dose less than 150 mg/m^2 (based on ideal body weight)

Endocrine therapy

• At least 4 weeks since prior dexamethasone

Radiotherapy

• No prior radiotherapy for amyloidosis

Surgery

• Not specified

Other

• No antihypertensive medications for at least 24 hours prior to, during, and for 1 hour after amifostine administration

• No other prior treatment