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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002829 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: recombinant interferon alfa Drug: cyclophosphamide Drug: etoposide Drug: mesna Procedure: bone marrow transplantation Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | AUTOLOGOUS AND ALLOGENEIC BONE MARROW TRANSPLANTATION FOR LOW GRADE LYMPHOMA |
| Estimated Enrollment: | 75 |
| Study Start Date: | February 1994 |
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
PROJECTED ACCRUAL: 35 allogeneic and 40 autologous patients are expected to be enrolled.
Eligibility| Ages Eligible for Study: | 15 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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
Contacts and Locations| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Study Chair: | Richard E. Champlin, MD | M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | CDR0000065027, MDA-DM-94009, NCI-G96-0994 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002829 History of Changes |
| Health Authority: | United States: Federal Government |
|
Waldenstrom macroglobulinemia recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent marginal zone lymphoma |
recurrent small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma |
|
Interferon Type I, Recombinant Immunologic Factors Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Cyclophosphamide Follicular Lymphoma Etoposide phosphate Lymphoma, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, Chronic Alkylating Agents Lymphoma Etoposide Interferon-alpha Immunoproliferative Disorders |
Interferons Immunosuppressive Agents Antiviral Agents Angiogenesis Inhibitors Recurrence Lymphatic Diseases Chronic Lymphocytic Leukemia Waldenstrom Macroglobulinemia B-cell Lymphomas Antineoplastic Agents, Alkylating Antirheumatic Agents Lymphoproliferative Disorders Interferon Alfa-2a Mesna |
|
Anti-Infective Agents Interferon Type I, Recombinant Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Alkylating Agents Lymphoma Interferon-alpha Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Growth Substances Interferons Antiviral Agents Angiogenesis Inhibitors Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Interferon Alfa-2a Lymphoproliferative Disorders Antirheumatic Agents |
