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Bone Marrow Transplantation in Treating Patients With Lymphoma



Bone Marrow Transplantation in Treating Patients With Lymphoma

For Condition: recurrent diffuse small lymphocytic/marginal zone lymphoma,Waldenstrom's Macroglobulinemia,recurrent grade I follicular small cleaved cell lymphoma,recurrent grade II follicular mixed cell lymphoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , M.D. Anderson Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells, and may be an effective treatment for lymphoma. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating patients with recurrent or residual low-grade lymphoma.
Details: OBJECTIVES: I. Examine the potential role of high dose etoposide, cyclophosphamide, total body irradiation and bone marrow transplantation for patients at high risk for disease progression. II. Determine the value of monitoring the quality of remission by PCR assessment of BCl-2. III. Evaluate the efficacy of alpha interferon for patients with evidence of residual or recurrent lymphoma. IV. Evaluate the efficacy of bone marrow purging by PCR assessment of BCl-2. PROTOCOL OUTLINE: Patients receive a brief 2-3 cycles of intensive chemotherapy to achieve minimum disease state. Etoposide is administered intravenously on day -8. Cyclophosphamide is infused intravenously over 2 hours daily on day -7 and -6. Patients receive mesna beginning 1 hour after initiation of the cyclophosphamide treatment. Total body irradiation is received on days -4, -3, -2 , and -1. On day 0 allogeneic or autologous bone marrow is infused intravenously. Patients with residual or recurrent lymphoma receive interferon alpha daily. PROJECTED ACCRUAL: 35 allogeneic and 40 autologous patients are expected to be enrolled.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/60 Years
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven low grade lymphoma in the following settings: Consolidation of newly diagnosed stage IV high-risk patients after 6-9 months of intensive conventional dose chemotherapy involving doxorubicin; High risk is defined as >=5 cm adenopathy and >=2 extranodal sites at diagnosis, or males with >=5 cm adenopathy and > 20% marrow infiltrate at diagnosis); Failure to achieve CR within 6 months in newly diagnosed patients with intensive doxorubicin treatment; Relapse patients who are sensitive to doxorubicin or ESHAP chemotherapies; Patients with resistant chemotherapy failure (allogeneic BMT only) - Patients with HLA-identical sibling donors are eligible for allogeneic bone marrow transplantation; other patients are eligible for autologous marrow transplantation - Bone marrow must be in complete or near complete remission (< 15 % malignant cells) in autologous transplant patients --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Prior chemotherapy allowed - Endocrine therapy: Not specified - Radiotherapy: No prior extensive radiotherapy - Surgery: Not specified --Patient Characteristics-- - Age: 15 to 60 years - Performance Status: Zubrod 0-2 - Hematopoietic: Not specified - Hepatic: Bilirubin no greater than 1.5 mg/dL - Renal: Creatinine no greater than 2.0 mg/dL - Cardiovascular: Cardiac ejection fraction at least 50% - Pulmonary: DLCO at least 50% - Other: No concomitant severe medical illnesses; No psychosis
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
RichardChamplin,  Study Chair,  M.D. Anderson Cancer Center

University of Texas - MD Anderson Cancer Center
Houston,  Texas,  77030
United States
 


Additional Information:
Study ID Numbers:  CDR0000065027;  MDA-DM-94009,NCI-G96-0994
Study Start Date: February 1994
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002829

Other Recurrent Diffuse Small Lymphocytic/marginal Zone Lymphoma Studies:
1. Monoclonal Antibody Therapy in Treating Patients With Recurrent Non-Hodgkin's Lymphoma

2. Radiation Therapy and Cyclophosphamide Plus Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Hodgkin's Disease or Non-Hodgkin's Lymphoma

3. 506U78 in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or T-cell Lymphoma

4. Monoclonal Antibody Therapy in Treating Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma

5. Rituximab and Interleukin-2 in Treating Patients With Low-Grade or Follicular Non-Hodgkin's Lymphoma That is Refractory to Rituximab

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