A Phase 2 interventional study of Recombinant Interferon Alfa and Cyclophosphamide in Lymphoma, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 15 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-07-30.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
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.
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.
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.
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This study's enrollment of 45 is above the median of 40 across 4,509 interventional studies indexed under Lymphoma.
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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
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
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: No prior extensive radiotherapy Surgery: Not specified
Biological: Recombinant Interferon Alfa · Drug: Cyclophosphamide · Drug: Etoposide · Drug: Mesna · Procedure: Bone Marrow Transplantation · Radiation: Radiation Therapy
Daily
Infused intravenously over 2 hours daily on Day -7 and -6.
Also known as: Cytoxan, Neosar
Administered intravenously on Day -8
Also known as: VePesid
Beginning 1 hour after initiation of the cyclophosphamide treatment.
Also known as: Mesnex
Infusion on Day 0.
Also known as: BMT
Total body irradiation is received on days -4, -3, -2 , and -1.
Also known as: RT, Radiotherapy, TBI
Number of Patients with Response
Time frame: 2 Years
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center