Rituximab, Vaccine Therapy, and GM-CSF in Treating Patients With Non-Hodgkin's Lymphoma
Phase II Trial of Maintenance Rituximab Plus FavId® and GM-CSF Immunotherapy in Patients With Treatment-Naive Indolent B-Cell Lymphoma
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Vaccines made from a person's cancer cells may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving rituximab together with vaccine therapy and GM-CSF may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with vaccine therapy and GM-CSF works in treating patients with indolent B-cell non-Hodgkin's lymphoma.
調査の概要
詳細な説明
OBJECTIVES:
- Determine the efficacy of immunotherapy comprising rituximab, autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId™), and sargramostim (GM-CSF), in terms of response rate (partial and complete) and event-free survival, in patients with indolent B-cell non-Hodgkin's lymphoma.
- Determine the safety of this regimen in these patients.
- Evaluate development of an immune response in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
- Induction therapy: Patients receive rituximab IV over 2-4 hours once weekly for 4 weeks. Patients are evaluated for response at month 3. Patients with responding or stable disease proceed to maintenance therapy. Patients with progressive disease are removed from study.
- Maintenance therapy: Patients receive rituximab as in induction therapy in months 7, 13, and 19. Patients also receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId™) subcutaneously (SC) once on day 1 and sargramostim (GM-CSF) SC once daily on days 1-4 in months 4-6, 8-11, 14, 16, 18, 20, 22, and 24. Patients with continued response after completing 2 years of therapy may continue to receive FavId™ and GM-CSF once every 3 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study.
研究の種類
入学 (予想される)
段階
- フェーズ2
連絡先と場所
研究場所
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Tennessee
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Nashville、Tennessee、アメリカ、37203
- 募集
- Sarah Cannon Cancer Center at Centennial Medical Center
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コンタクト：
- Clinical Trials Office - Sarah Cannon Cancer Center at Centenn
- 電話番号：615-329-7274
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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 confirmed indolent B-cell non-Hodgkin's lymphoma of 1 of the following subtypes:
- Grade 1 or 2 follicular lymphoma
- Tumor must be accessible to biopsy or biopsy material available for preparation of autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId™)
- Measurable or evaluable disease after node biopsy
- No mantle cell, marginal zone, MALT-type, small lymphocytic, or grade 3 follicular (follicular large cell) lymphoma
- No CNS involvement with lymphoma
PATIENT CHARACTERISTICS:
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Platelet count > 100,000/mm^3
- WBC ≥ 3,000/mm^3
Hepatic
- AST and ALT ≤ 2 times upper limit of normal
- Bilirubin ≤ 2 mg/dL
Renal
- Creatinine ≤ 1.5 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 30 days after completion of study treatment
- HIV negative
- No other medical or psychiatric disease that would preclude study compliance
- No other malignancy (active or treated) within the past 5 years
PRIOR CONCURRENT THERAPY:
Radiotherapy
- Prior local radiotherapy allowed
Other
- No other prior anticancer therapy
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）
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
|---|
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Event-free survival by Kaplan-Meier
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二次結果の測定
結果測定 |
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安全性
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応答時間
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Overall response rate (partial and complete response) at month 6 and any time
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Time-to-progression by Kaplan-Meier
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Immune response by cellular or humoral anti-idiotype response positive
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協力者と研究者
スポンサー
捜査官
- スタディチェア：John F. Bender, PharmD、Favrille
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
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
- CDR0000449719
- FAV-ID-70
- FAV-ID-LYM-31
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。
リツキシマブの臨床試験
-
Aprea Therapeutics終了しましたマントル細胞リンパ腫 | 慢性リンパ性白血病 | 非ホジキンリンパ腫アメリカ