Vaccine Therapy in Treating Patients With Stage IV Melanoma
A Phase I/II Pilot Study Of Intranodal Delivery Of A Plasmid DNA (Synchrovax SEM Vaccine) In Stage IV Melanoma Patients
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Infusing the vaccine directly into a lymph node may cause a stronger immune response and kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma.
調査の概要
詳細な説明
OBJECTIVES:
- Determine the maximum tolerated dose of intranodal Synchrovax SEM plasmid DNA vaccine in patients with stage IV melanoma.
- Determine the safety and tolerability of this drug in these patients.
- Determine the immunological response, as measured by changes in frequency of T cells specific against vaccine-encoded epitopes before and after treatment, in patients treated with this drug.
- Determine the clinical response, as measured by lactic dehydrogenase levels and radiologic assessment of lesions, in patients treated with this drug.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive Synchrovax SEM plasmid DNA vaccine by continuous intranodal infusion on days 1-4. Treatment repeats every 14 days for up to 4 courses in the absence of unacceptable toxicity. Patients with evidence of stable or responding disease are eligible for 4 additional courses of treatment.
Cohorts of 6 patients receive escalating doses of Synchrovax SEM plasmid DNA vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 10 days after the last dose of study drug.
PROJECTED ACCRUAL: A total of 6-18 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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Arizona
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Tucson、Arizona、アメリカ、85724
- Arizona Cancer Center at University of Arizona Health Sciences Center
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California
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Los Angeles、California、アメリカ、90089
- USC/Norris Comprehensive Cancer Center and Hospital
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Massachusetts
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Boston、Massachusetts、アメリカ、02118
- Cancer Research Center at Boston Medical Center
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Minnesota
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Rochester、Minnesota、アメリカ、55905
- Mayo Clinic Cancer Center
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Oregon
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Portland、Oregon、アメリカ、97213-2967
- Earle A. Chiles Research Institute at Providence Portland 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 confirmed stage IV melanoma
Must have tumor tissue available for determining antigen expression
- At least 10% of tumor cells must stain positive for Melan-A/Mart-1 by immunohistochemistry
- HLA-A2 positive
- No brain metastases unless completely resected or without evidence of disease after treatment
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- More than 3 months
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm3
- WBC at least 3,000/mm3
- Platelet count at least 75,000/mm3
- Hemoglobin at least 9 g/dL
Hepatic:
- SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2.5 times ULN
- Bilirubin no greater than 1.5 times ULN
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative
Renal:
- Creatinine no greater than 1.5 times ULN
- Urea no greater than 2.6 times ULN
Other:
- Not pregnant, nursing, or planning to become pregnant within 6 months of treatment completion
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No medical, sociological, or psychological impediments that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy
- At least 4 weeks since prior immunomodulatory drugs
- No other concurrent immunotherapy
- No concurrent immunomodulatory drugs
Chemotherapy:
- At least 4 weeks since prior chemotherapy
- No concurrent chemotherapy
Endocrine therapy:
- At least 4 weeks since prior systemic corticosteroids
- No concurrent systemic corticosteroids
Radiotherapy:
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
Other:
- At least 4 weeks since prior investigational drugs
- No other concurrent investigational drugs
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
- 介入モデル：並列代入
- 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：Cohort 1
The first cohort of 6 patients received 500 ug of Synchrovax SEM plasmid DNA vaccine.
All patients were to be monitored for dose limiting toxicities DLTs) for a minimum of 2 weeks after their second infusion of vaccine on Day 15 before allowing patients to enroll at the next dose group.
The decision to progress to the next dose group was to be based on occurrence of DLTs observed in 1 or fewer (<33%) patients of a 6 patient cohort.
|
Cancer Vaccine, Immunotherapy, 500 ug
Cancer Vaccine, Immunotherapy, 1000 ug
Cancer Vaccine, Immunotherapy, 1500 ug
|
|
実験的：Cohort 2
The second cohort of 6 patients received 1000 ug of Synchrovax SEM plasmid DNA vaccine.
All patients were to be monitored for dose limiting toxicities DLTs) for a minimum of 2 weeks after their second infusion of vaccine on Day 15 before allowing patients to enroll at the next dose group.
The decision to progress to the next dose group was to be based on occurrence of DLTs observed in 1 or fewer (<33%) patients of a 6 patient cohort.
|
Cancer Vaccine, Immunotherapy, 500 ug
Cancer Vaccine, Immunotherapy, 1000 ug
Cancer Vaccine, Immunotherapy, 1500 ug
|
|
実験的：Cohort 3
The third cohort of 6 patients received 1500 ug of Synchrovax SEM plasmid DNA vaccine.
The maximum tolerated dose (MTD) was to be determined by the observation of DLT at each dose group.
|
Cancer Vaccine, Immunotherapy, 500 ug
Cancer Vaccine, Immunotherapy, 1000 ug
Cancer Vaccine, Immunotherapy, 1500 ug
|
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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The primary objective of the study was to evaluate the safety and tolerability of Synchrovax® pSEM Vaccine measured by the adverse event and severe adverse event profile.
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二次結果の測定
結果測定 |
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The secondary objective of the study was to determine the immunological response of patients as measured by tetramer assay and to assess clinical response by LDH levels and radiological assessment of lesions.
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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：Chief Scientific Officer、Mannkind Corporation
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
本研究に関する用語
キーワード
その他の研究ID番号
- CDR0000069252
- CTL-26-35
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。