Immune Mobilization of Autologous Peripheral Blood Stem Cells Using Interleukin-2 and GM-CSF
調査の概要
状態
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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New Hampshire
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Lebanon、New Hampshire、アメリカ、03756
- Dartmouth-Hitchcock 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
Inclusion Criteria:
- All patients must have pathologic diagnosis of one of the following malignancies: Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma or other plasma cell dyscrasia (Waldenstrom, Amyloidosis), Leukemia (AML, ALL, CLL)
- Prior Treatment: > 2 weeks prior to initiation of therapy.
- Performance Status: Karnofsky > 70%
- Age >18
- Life Expectancy > 4 months
- Bone Marrow: bone marrow biopsy and aspirate
- Blood counts: The patient must have adequate bone marrow function, i.e. a total WBC of > 2,000/ul, a Hgb of > 7 mg/dl, and a platelet count of > 50,000/ul, unless this abnormality is believed to be due to the underlying disease.
- Pulmonary function tests: DLCO > 55% predicted.
- Cardiac: Left ventricular ejection fraction of > 40% by radionuclide scan or echocardiography.
- Liver function tests (bilirubin, alkaline phosphatase, and SGOT/SGPT) < 3 x normal (unless believed to be elevated due to disease).
- No significant co-morbid medical or psychiatric illness that would significantly compromise the patient's clinical care and chances of survival.
- Informed Consent: Informed consent must be signed prior to the treatment. Patients must be aware of the neoplastic nature of their disease and willingly consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side effects, risks and discomforts. The patient is not deemed eligible if there is any other serious medical or psychiatric illness that would prevent informed consent. (Human protection committee approval of this protocol and a consent form is required.)
Exclusion Criteria:
- Medical, social, or psychological factors which would prevent the patient from receiving or cooperating with the full course of therapy.
- Evidence on physical exam, LP, CT, or MRI scans of CNS involvement with malignancy.
- Uncontrolled or severe cardiovascular disease, including recent (< 6 months) myocardial infarction, congestive heart failure, angina (symptomatic despite optimal medical management), life-threatening arrhythmia, or hypertension or clinically significant obstructive/restrictive pulmonary disease.
- Serology positive for HIV
- History of seizures.
- Concurrent or expected need for therapy with systemic corticosteroids (since systemic steroids may suppress the effects of IL-2).
- Current and clinically significant pleural effusion, pericardial effusion, or ascites.
- Positive pregnancy test or presence of lactation.
- Uncontrolled active infection.
- Documented hypersensitivity to any of the drugs used in the protocol.
- No concomitant, ongoing malignancy that is life-threatening, based on PI's evaluation
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
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:IL-2 and GM-CSF for Mobilization
Immune Mobilization of Autologous Peripheral Blood Stem Cells Using Interleukin-2 and GM-CSF
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GM-CSF (Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor) The dose and duration of GM-CSF (7.5 mcg/kg/day) was selected. If used alone, this dose and duration would result in effective mobilization. GM-CSF will be started on Day #7 and will continue until completion of leukapheresis. G-CSF will be started (5mcg/kg/d) on Day #7 and will be given each morning. G-CSF will continue until completion of leukapheresis. IL-2 dose escalation: IL-2 will be administered as a single daily subcutaneous injection each evening until completion of leukapheresis. Escalation of the dose of IL-2 will be performed using the below schema with the following levels. Patients will be started on Level 1. (Level 0 is included since, if toxicity is meet in Level 1, the dose will be decreased to Level 0). Level 0 - 3 x 105 i.u./m2/day for 11 days Level 1 - 6 x 105 i.u./m2/day for 11 days Level 2 - 1 x 106 i.u. /m2/day for 11 days as above Level 3 - 1.5 x 106 i.u. /m2/day for 11 days as above Level 4 - 2 x 106 i.u. /m2/day for 11 days as above |
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 |
時間枠 |
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Can IL-2 be administered with GM-CSF to efficiently mobilize autologous peripheral blood stem cells. This study will determine the maximum tolerated dose of IL-2 and the optimal biological dose with GM-CSF for stem cell mobilization.
時間枠:5 Years
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5 Years
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二次結果の測定
結果測定 |
時間枠 |
---|---|
Will immune-mobilized stem cell products be well tolerated once infused into patients and will engraft normally following high-dose chemotherapy and APBSCT.
時間枠:5 Years
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5 Years
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協力者と研究者
捜査官
- 主任研究者:Kenneth R Meehan, MD、Dartmouth-Hitchcock Medical 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 (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
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。
GM-CSFの臨床試験
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Nationwide Children's HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)募集
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Eastern Cooperative Oncology Group完了急性非リンパ性白血病の成人患者(55歳以上)
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San Antonio Military Medical CenterNuGenerex Immuno-Oncology; Norwell, Inc.完了
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Centre for Endocrinology and Reproductive Medicine...完了
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Radboud University Medical Center完了
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Children's Oncology GroupNational Cancer Institute (NCI)完了