Peripheral Stem Cell Transplantation With Specially Treated Stem Cells in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease
Autologous Transplantation for Non-Hodgkin's Lymphoma and Hodgkin's Disease Using Retrovirally Marked Peripheral Blood Progenitor Cells Obtained After In Vivo Mobilization Using Hematopoietic Cytokines Plus Chemotherapy
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. Combining chemotherapy and radiation therapy with peripheral stem cell transplantation using specially treated stem cells may allow the doctor to give higher doses of chemotherapy drugs and radiation therapy and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation using specially treated stem cells in treating patients who have non-Hodgkin's lymphoma or Hodgkin's disease.
調査の概要
状態
条件
詳細な説明
OBJECTIVES:
- Determine whether priming with hematopoietic cytokines and chemotherapy increases the yield of hematopoietic progenitors in peripheral blood stem cells (PBSC) in patients with non-Hodgkin's lymphoma or Hodgkin's disease undergoing autologous PBSC transplantation.
- Determine whether in vitro studies can predict the transduction efficiency of early and late engrafting hematopoietic stem cells in this patient population undergoing this treatment.
- Determine whether in vitro transduction of a graft product stable long term transduction of marrow cells in these patients after autologous transplantation.
OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously (SC) twice daily on days 1-7. Peripheral blood stem cells (PBSC) are collected on days 5-7. Patients receive cyclophosphamide IV over 2 hours, mitoxantrone IV, and cytarabine IV every 12 hours for 2 doses on day 10, and dexamethasone every 12 hours for 4 doses on days 10 and 11. Patients receive G-CSF SC for the next 10-20 days. Additional PBSC are collected on days 25-28 or 29. Beginning 7 days before PBSC transplantation, patients receive cyclophosphamide IV over 2 hours on days -7 and -6 and total body irradiation (TBI) twice daily on days -4 to -1. Patients unable to tolerate TBI receive cyclophosphamide IV over 2 hours on days -6 to -3, carmustine IV over 1 hour on days -6, and etoposide IV over 1 hour every 12 hours on days -6 to -4. Retrovirally transduced PBSC are reinfused on day 0 followed by another course of G-CSF SC until hematopoietic recovery.
Patients are followed at 1, 3, 6, 9, 12, 18, and 24 months and then annually thereafter.
PROJECTED ACCRUAL: A total of 15-20 patients will be accrued for this study within 12-15 months.
研究の種類
段階
- フェーズ2
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:
Intermediate or high grade non-Hodgkin's lymphoma (NHL) or Hodgkin's disease (HD)
- Chemotherapy sensitive, initial partial remission OR
- Relapse after initial complete or partial remission
- Low grade NHL eligible provided progression following initial partial or complete remission
- Ineligible for ongoing allogeneic marrow donor transplant protocols or elected not to participate in such protocols
- No chemotherapy resistant NHL or HD 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:
- 18 to 70
Performance status:
- Karnofsky 90-100%
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- AST less than 2.5 times upper limit of normal (ULN)
- Bilirubin less than 2.5 times ULN
Renal:
- Creatinine less than 2.0 mg/dL
Cardiovascular:
- Resting LVEF at least 40%
- No unstable ischemic heart disease
Pulmonary:
- Spirometry and DLCO greater than 50% predicted
Other:
- No active uncontrolled infection
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
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
協力者と研究者
捜査官
- スタディチェア:Daniel J. Weisdorf, MD、Masonic Cancer Center, University of Minnesota
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 (実際)
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
- 免疫系疾患
- 組織型別の新生物
- 新生物
- リンパ増殖性疾患
- リンパ疾患
- 免疫増殖性疾患
- リンパ腫
- ホジキン病
- リンパ腫、非ホジキン
- 薬の生理作用
- 薬理作用の分子機構
- 抗感染剤
- 自律神経剤
- 末梢神経系エージェント
- 抗ウイルス剤
- 酵素阻害剤
- 鎮痛剤
- 感覚系エージェント
- 抗炎症剤
- 抗リウマチ剤
- 代謝拮抗薬、抗腫瘍薬
- 代謝拮抗剤
- 抗悪性腫瘍薬
- 免疫抑制剤
- 免疫学的要因
- 制吐薬
- 胃腸薬
- グルココルチコイド
- ホルモン
- ホルモン、ホルモン代替物、およびホルモン拮抗薬
- 抗腫瘍剤、ホルモン剤
- 抗悪性腫瘍薬、アルキル化
- アルキル化剤
- 骨髄破壊的アゴニスト
- 抗悪性腫瘍剤、ファイトジェニック
- トポイソメラーゼ II 阻害剤
- トポイソメラーゼ阻害剤
- デキサメタゾン
- シクロホスファミド
- エトポシド
- シタラビン
- ミトキサントロン
- カームスティン
その他の研究ID番号
- 1999LS080
- MT1999-19 (その他の識別子:Blood and Marrow Transplantation Program)
- NCI-G00-1807
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。