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
High-Dose Chemoradiotherapy With Stem Cell Allogeneic Cellular Rescue in Patients With Relapsed or Refractory Hematologic Malignancy - A Phase I/II Study
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.
調査の概要
状態
条件
詳細な説明
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
研究の種類
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
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Illinois
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Chicago、Illinois、アメリカ、60611
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- マスキング：なし（オープンラベル）
協力者と研究者
スポンサー
捜査官
- スタディチェア：Leo I. Gordon, MD、Robert H. Lurie Cancer Center
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- NU 95H4T
- NU-95H4T
- NCI-G00-1692
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