Vorinostat in Treating Patients With Relapsed or Refractory Advanced Hodgkin's Lymphoma
A Phase II Trial of Suberoylanilide Hydroxamic Acid (NSC-701852) for Recurrent or Primary Refractory Hodgkin's Lymphoma
調査の概要
状態
条件
介入・治療
詳細な説明
PRIMARY OBJECTIVES:
I. To evaluate the response probability (complete, complete unconfirmed, and partial) in patients with relapsed or refractory Hodgkin's lymphoma.
II. To estimate 1-year progression-free survival and overall survival in patients with relapsed or refractory Hodgkin's lymphoma treated with SAHA.
III. To assess the toxicity profile of SAHA in this patient population. IV. To perform gene expression profiling on tumor tissue before and after treatment in order to explore in a preliminary manner the association between response and specific gene expression results.
OUTLINE: This is a multicenter study.
Patients receive oral vorinostat twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR.
After completion of study treatment, patients are followed every 6 months for 2 years and then annually for 3 years.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Texas
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San Antonio、Texas、アメリカ、78245
- Southwest Oncology Group (SWOG) Research Base
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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:
- Patients must have histologically or cytologically confirmed relapsed/refractory Hodgkin's lymphoma of any subtype; patients with lymphocyte predominant Hodgkin's disease (LPHD) are also eligible; clear evidence of disease progression or lack of response after the most recent therapy, including local radiation is required
- Patients must be willing to submit specimens for correlative studies
- All patients must have bidimensionally measurable disease documented within 28 days prior to registration; patients with non-measurable disease in addition to measurable disease must have all non-measurable disease assessed within 42 days prior to registration
- Patients must have unilateral bone marrow aspirate and biopsy performed within 42 days prior to registration
- Patients may have had up to five prior chemotherapy regimens
- Patients must have completed chemotherapy at least 28 days prior to registration and all toxicities must have resolved (in the opinion of the treating investigator); if last regimen included nitrosoureas or mitomycin then 42 days must have elapsed since completion of treatment; patients must not have taken valproic acid, or another histone deacetylase inhibitor, for at least 14 days prior to registration
- Patients must have completed all radiotherapy at least 14 days prior to registration and all toxicities must have resolved (in the opinion of the treating investigator)
- Patients who relapse after autologous stem cell transplant may be enrolled if they are at least three months after transplant, and after allogeneic transplant if they are at least one year posttransplant; patients should have no active related infections (i.e., fungal or viral); in the case of allogeneic transplant relapse, there should be no active acute graft versus host disease (GvHD) of any grade, and no chronic graft versus host disease other than mild skin, oral, or ocular GvHD not requiring systemic immunosuppression
- Patients must have a Zubrod performance status of 0-2
- Patients must have a CT scan of the chest/abdomen and pelvis performed within 28 days prior to registration
- Patients must not have clinical evidence of central nervous system involvement by lymphoma; any laboratory or radiographic tests performed to assess CNS involvement must be negative within 42 days of registration
- Serum LDH must be measured within 28 days prior to registration
- Absolute neutrophil count >- 1,000/mcL
- Platelet count >= 100,000/mcL
- SGOT/SGPT < 2.5 x the institutional upper limit of normal
- Serum creatinine < 2 x the institutional upper limit of normal
- Patients with a history of allergic reactions attributed to compounds of similar chemical or biological composition to SAHA are ineligible
- Patients must not have plans to receive concurrent hormonal, biological or radiation therapy; patients with potentially curative options such as salvage therapy with chemotherapy or hematopoietic stem cell transplant (HSCT) are not eligible
- Patients with a history of prior myocardial infarction, unstable angina, or stroke within 6 months are ineligible
- Patients known to be HIV-positive and receiving combination antiretroviral therapy are ineligible; in addition, HIV-positive patients not receiving combination antiretroviral therapy are also ineligible
- No prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer for which the patient has been disease-free for five years
- Pregnant or nursing women may not participate; women or men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
- Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
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 |
---|---|
実験的:Treatment (vorinostat)
Patients receive oral vorinostat twice daily on days 1-14.
Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR.
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相関研究
経口投与
他の名前:
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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 |
メジャーの説明 |
時間枠 |
---|---|---|
Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
時間枠:after every 3 cycles on treatment
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Complete Response(CR) is a complete disappearance of all disease with the exception of nodes.
No new lesions.
previously enlarged organs must have regressed and not be palpable.
Bone marrow(BM) must be negative if positive at baseline.
Normalization of markers.
CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM.
Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline.
No new lesions and no increase in the size of liver, spleen or other nodes.
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after every 3 cycles on treatment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Progression-Free Survival
時間枠:after every 3 cycles on treatment, then every 6 months for 2 years, then annually for a total of 5 years.
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Measured from date of registration to date of first observation of progression or death, or last contact date.
Progression is defined as a 50% increase in sum of products of greatest diameters (SPD) of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; appearance of a new lesion/site; unequivocal progression of non-measurable disease in the opinion of the treating physician; death due to disease without prior documentation of progression.
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after every 3 cycles on treatment, then every 6 months for 2 years, then annually for a total of 5 years.
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Overall Survival
時間枠:after every 3 cycles on treatment, then every 6 months for 2 years, then annually for a total of 5 years.
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Measured from date of registration to death, or last contact date
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after every 3 cycles on treatment, then every 6 months for 2 years, then annually for a total of 5 years.
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協力者と研究者
捜査官
- 主任研究者:Mark Kirschbaum、Southwest Oncology Group
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
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。
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