Chemotherapy and Radiation Therapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory T-cell Lymphoma, Hodgkin's Lymphoma, or Non-Hodgkin's Lymphoma

Study Overview
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Brief Summary
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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. Bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and radiation therapy and kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy and radiation therapy plus bone marrow or peripheral stem cell transplantation in treating patients who have refractory or relapsed T-cell lymphoma, Hodgkin's lymphoma, or non-Hodgkin's lymphoma.

Detailed Description
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OBJECTIVES: Determine the toxicity of an intensive program of chemoradiotherapy followed by HLA identical related bone marrow or peripheral blood stem cell transplantation in patients with relapsed or refractory cutaneous T-cell lymphoma, Hodgkin's lymphoma, or non-Hodgkin's lymphoma. Determine the response rate and disease free survival in patients treated with this regimen. OUTLINE: HLA identical related donors undergo harvest of bone marrow or peripheral blood stem cells (PBSC). Patients are assigned to one of two treatment groups based on prior radiation to abdomen or mediastinum: Group A (prior radiation no greater than 2,000 cGy): Patients with complete response (CR) or partial response (PR) after completion of chemotherapy receive cyclophosphamide IV over 1 hour on days -6 and -5, followed by total body irradiation twice daily on days -4 to -1. Patients with minimal response after completion of chemotherapy receive cyclophosphamide IV over 1 hour on days -8 and -7, followed by etoposide IV over 30 hours beginning on day -6, followed by total body irradiation twice daily on days -4 to -1. Group B (prior radiation greater than 2,000 cGy): Patients with CR or PR after completion of chemotherapy receive oral busulfan every 6 hours on days -7 to -4, followed by cyclophosphamide IV over 1 hour on days -3 and -2. Patients with minimal response after completion of chemotherapy receive oral busulfan every 6 hours on days -9 to -6, followed by cyclophosphamide IV over 1 hour on days -5 and -4, followed by etoposide IV over 30 hours beginning on day -3. Both groups: Bone marrow or PBSC are reinfused on day 0. Patients with bulky nodal disease (greater than 5 cm) may undergo involved field radiotherapy two weeks before transplantation. Patients are followed every month for 1 year. PROJECTED ACCRUAL: Not specified

Official Title
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High-Dose Chemoradiotherapy With Stem Cell Allogeneic Cellular Rescue in Patients With Relapsed or Refractory Hematologic Malignancy - A Phase I/II Study

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: busulfan
* Drug: cyclophosphamide
* Drug: etoposide
* Procedure: allogeneic bone marrow transplantation
* Procedure: bone marrow ablation with stem cell support
* Procedure: peripheral blood stem cell transplantation
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven relapsed or refractory cutaneous T-cell lymphoma, Hodgkin's lymphoma, or non-Hodgkin's lymphoma of the following types: Diffuse small lymphocytic/marginal zone Grade I follicular small cleaved cell Grade II follicular mixed cell Diffuse small cleaved cell Grade III follicular large cell Diffuse mixed cell Diffuse large cell Immunoblastic large cell HLA identical related donor available Phenotypically HLA identical, MLC nonstimulatory donor eligible if no HLA identical related donor is available Relapse following autologous bone marrow transplantation allowed if an HLA identical related donor is available Eligible for total body irradiation No active uncontrolled CNS disease NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of indolent or aggressive lymphoma will replace the former terminology of low, intermediate, or high grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: Over 15 to physiologic age 60 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No congestive heart failure No myocardial infarction within the past 3 months No significant arrhythmia requiring medication Resting LVEF normal Pulmonary: No significant nonneoplastic pulmonary disease (e.g., chronic obstructive pulmonary disease) that would preclude therapy with cytotoxic drugs DLCO at least 50% of predicted* OR FEV1 and/or FVC at least 50% of predicted* NOTE: * Unless due to lymphoma, including Hodgkin's lymphoma Other: Not pregnant Negative pregnancy test No active serious medical condition that would preclude aggressive cytotoxic chemotherapy HIV negative and no clinical evidence of AIDS PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: busulfan|nan|
|Drug: cyclophosphamide|nan|
|Drug: etoposide|nan|
|Procedure: allogeneic bone marrow transplantation|nan|
|Procedure: bone marrow ablation with stem cell support|nan|
|Procedure: peripheral blood stem cell transplantation|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent adult Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent mycosis fungoides/Sezary syndrome, 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