Vaccine Therapy in Treating Patients With Liver Cancer
A Phase I/II Trial Testing Immunization With Dendritic Cells Pulsed With Four AFP Peptides in Patients With Hepatocellular Carcinoma
RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have liver cancer.
調査の概要
詳細な説明
OBJECTIVES:
- Determine the maximum tolerated dose of alpha-fetoprotein peptide-pulsed autologous dendritic cells in HLA-A*0201-positive patients with hepatocellular carcinoma.
- Determine the safety and toxicity of this regimen in these patients.
- Determine the immunological effects of this regimen in these patients.
- Determine the progression-free survival and clinical responses in patients treated with this regimen.
OUTLINE: This is a dose-escalation study.
Patients receive alpha-fetoprotein peptide-pulsed autologous dendritic cells intradermally on day 1. Treatment repeats every 2 weeks for a total of 3 doses in the absence of unacceptable toxicity.
Cohorts of 3-12 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 2 of 12 patients experience dose-limiting toxicity.
Patients are followed at weeks 1, 4, and 12 and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study.
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
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California
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Los Angeles、California、アメリカ、90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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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:
- HLA-A*0201 positive adults over the age of 18.
- Have HCC with a serum AFP determination >30ng/ml.
- Both male and female patients may be enrolled.
- Karnofsky Performance Status greater than or equal to 70 percent.
- No previous evidence of class 3 or greater New York Heart Association cardiac insufficiency or coronary artery disease.
- No previous evidence of opportunistic infection.
Adequate baseline hematological function as assessed by the following laboratory values with 30 days prior to study entry:
- Hemoglobin >9.0g/dl
- Platelets >50000/mm3
- Absolute Neutrophil Count >1,000/mm3
- Child-Pugh Class A or B for chronic liver disease.
- Ability to give informed consent.
Exclusion Criteria:
- Any congenital or acquired condition leading to inability to generate an immune response, including concomitant immune suppressive therapy.
- Concomitant steroid therapy or chemotherapy, or any of these other treatments < 30 days before the first vaccination.
- Females of child-bearing potential must have negative serum beta-HCG pregnancy test (within Day -14 to Day 0).
- Acute infection: any acute viral, bacterial, or fungal infection, which requires specific therapy. Acute therapy must have been completed within 14 days prior to study treatment.
- HIV-infected patients.
- Patients with any underlying conditions which would contraindicate therapy with study treatment.
- Patients with organ allografts.
- O2 sat <91% on room air; dyspnea at rest.
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
See intervention description.
|
Increasing doses of AFP will be given to groups of 3 intradermally.
Subjects will receive 3 biweekly vaccinations.
At least 2 patients at a given dose must have received their complete 3 vaccination schedule with a 30 day observation period after the last vaccination before a higher dose is initiated.
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 |
時間枠 |
|---|---|
|
Dose limiting toxicity and maximum tolerable dose.
時間枠：1 year
|
1 year
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Generation of AFP specific immunity.
時間枠：3 years
|
3 years
|
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Progression-free survival.
時間枠：3 years
|
3 years
|
|
clinical response in patients with measurable disease.
時間枠：3 years
|
3 years
|
協力者と研究者
捜査官
- 主任研究者：James S. Economou, MD、Jonsson Comprehensive Cancer 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
本研究に関する用語
その他の研究ID番号
- CDR0000068806
- UCLA-0001026
- NCI-G01-1997
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。