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Second Autologous Stem Cell Transplantation in Treating Patients With Persistent or Recurrent Primary Systemic (AL) Amyloidosis



Second Autologous Stem Cell Transplantation in Treating Patients With Persistent or Recurrent Primary Systemic (AL) Amyloidosis

For Condition: primary systemic amyloidosis
Status: Recruiting
Sponsor(s): Boston Medical Center ,
Synopsis: RATIONALE: A second autologous stem cell transplantation may be effective treatment for persistent or recurrentprimary systemic (AL) amyloidosis. PURPOSE: Phase II trial to study the effectiveness of a second autologous stem cell transplantation in treating patients who have persistent or recurrent primary systemic (AL) amyloidosis.
Details: OBJECTIVES: - Determine the feasibility and tolerability of second autologous stem cell transplantation in patients with persistent or recurrent AL amyloidosis. - Determine the response rate and durability of response in patients treated with this regimen. - Determine immune reconstitution in patients treated with this regimen. OUTLINE: - Mobilization: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning before the initiation of stem cell collection and continuing until the day before the completion of stem cell collection. If an inadequate number of peripheral blood stem cells are collected, patients may undergo bone marrow harvest. - Preparative regimen: Patients receive high-dose melphalan IV over 20 minutes on days –3 and –2. - Autologous stem cell transplantation: Autologous stem cells are reinfused on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed at 3 months, 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 19 patients will be accrued for this study within 5-6 years.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed AL amyloidosis - Persistent or recurrent disease after 1 course of prior high-dose chemotherapy - Previously treated with autologous stem cell transplantation - Significant initial improvement in organ function after prior high-dose melphalan, defined by at least 1 of the following: - Complete hematologic remission (e.g., absence of monoclonal spike by immunofixation in serum and urine AND less then 5% plasma cells in bone marrow with no clonal predominance) OR partial hematologic response (e.g., any decrease in serum or urine monoclonal protein OR decrease in bone marrow plasmacytosis) - Greater than 50% reduction in proteinuria with preservation of creatinine clearance - Greater than 50% reduction in alkaline phosphatase OR at least 2 cm decrease in liver size by physical exam - Subjective neurologic improvement, as confirmed by neurologist - Cardiac stabilization of disease confirmed by echocardiography defined as less than 2 mm increase in mean wall thickness and/or less than 20 g increase in left ventricular mass - Improvement in performance status* NOTE: *This criteria alone does not constitute significant improvement in organ function - No myelodysplastic syndromes - No abnormal bone marrow cytogenetics - Prior stem cell yield must have been 2 x 10^6 CD34+ cells/kg PATIENT CHARACTERISTICS: Age - 18 to 65 Performance status - SWOG 0-2 Life expectancy - More than 6 months Hematopoietic - See Disease Characteristics Hepatic - See Disease Characteristics Renal - See Disease Characteristics Cardiovascular - See Disease Characteristics - LVEF 45% by MUGA or echocardiogram Pulmonary - DLCO 50% Other - Not pregnant or nursing - Fertile patients must use effective contraception - Acceptable toxicity from first transplantation, confirmed by the transplant team - HIV negative - No other concurrent malignancy except treated skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics Chemotherapy - See Disease Characteristics - No chemotherapy after first transplantation Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
KarenQuillen,  Principal Investigator,  Boston Medical Center

Cancer Research Center at Boston Medical Center *Recruiting*
Boston,  Massachusetts,  02118
United States
Recruiting Karen  Quillen 617-638-7828


Additional Information:
Study ID Numbers:  CDR0000347379;  BUMC-2001-0156
Study Start Date: 
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075608

Other Primary Systemic Amyloidosis Studies:
1. Iododoxorubicin in Treating Patients With Primary Systemic Amyloidosis

2. High-Dose Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Amyloidosis

3. Second Autologous Stem Cell Transplantation in Treating Patients With Persistent or Recurrent Primary Systemic (AL) Amyloidosis

4. Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma

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

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Second Autologous Stem Cell Transplantation in Treating Patients With Persistent or Recurrent Primary Systemic (AL) Amyloidosis
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