Allogeneic Epstein Barr Virus-Specific Cytotoxic T-Lymphocytes in Treating Patients With Progressive, Relapsed, or Refractory Hodgkin's Lymphoma
A Phase I Pilot Trial to Evaluate the Toxicity of Epstein-Barr Virus Specific T-Lymphocytes or Peripheral Blood Mononuclear Cells for the Treatment of Relapsed/Refractory Hodgkin's Disease
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Donor white blood cells that are treated in the laboratory with Epstein-Barr virus may be effective treatment for Hodgkin's lymphoma.
PURPOSE: Phase I trial to study the effectiveness of allogeneic Epstein-Barr virus-specific cytotoxic T cells in treating patients who have progressive, relapsed, or refractory Hodgkin's lymphoma.
調査の概要
詳細な説明
OBJECTIVES:
- Determine the toxicity of allogeneic Epstein Barr virus (EBV)-specific cytotoxic T-lymphocytes (EBV CTL) in patients with progressive, relapsed, or refractory EBV-positive Hodgkin's lymphoma.
- Detect alterations in the anti-EBV cellular immunity of patients treated with EBV CTL.
OUTLINE: Donors undergo leukapheresis. Epstein Barr virus-specific cytotoxic T lymphocytes (EBV CTL) are cultured in vitro.
Patients receive an infusion of EBV CTL over 10 minutes on day 0. The EBV CTL infusion is preceded by 3 doses of fludarabine. Patients then receive interleukin-2 injections for 12 days after the EBV CTL infusion.
Patients are followed weekly for 1.5 months, twice a month for 1.5 months, and then monthly for 3 months.
PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study.
研究の種類
段階
- フェーズ 1
連絡先と場所
研究場所
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Pennsylvania
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Hershey、Pennsylvania、アメリカ、17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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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 Hodgkin's lymphoma
- Progressive, relapsed, or refractory disease after prior chemotherapy, radiotherapy, and/or stem cell transplantation
- Epstein Barr virus (EBV) positive by immunohistochemical staining for LMP-1 or 2 OR the presence of EBV RNA (EBER)
Availability of an HLA identical or haploidentical donor for cytotoxic T-lymphocytes, meeting the following criteria:
- EBV seropositive
- HIV negative
- HTLV-1 negative
- Hepatitis B surface antigen and hepatitis B core antibody IgM negative
- Hepatitis C antibody negative
- Must share at least 1 HLA haplotype with donor
PATIENT CHARACTERISTICS:
Age:
- 18 to 75
Performance status:
- Not specified
Life expectancy:
- At least 8 weeks
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin less than 2.0 mg/dL
SGOT/SGPT less than 2.5 times normal (unless liver metastases are present)
- If there is liver involvement by disease, an obvious relationship between SGOT/SGPT and disease activity is required
- No hepatic dysfunction causing moribundity
Renal:
- Creatinine clearance greater than 50 mL/min
- No renal dysfunction causing moribundity
Cardiovascular:
- No cardiac dysfunction causing moribundity
Pulmonary:
- No pulmonary dysfunction causing moribundity
Other:
- No neurologic dysfunction causing moribundity
- No history of severe transfusion reactions with blood products (including fetal calf serum)
- Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- See Disease Characteristics
- No concurrent antimetabolites
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
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:Kenneth G. Lucas, MD、Milton S. Hershey Medical Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
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
- CDR0000068109
- PSCI-2003-257
- UAB-0002
- NCI-G00-1829
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。