Vaccine Therapy in Treating Patients With Metastatic Solid Tumors
Intra-Lesional rF-B7.1 Versus rF-Tricom Vaccine In The Treatment Of Metastatic Cancer
調査の概要
状態
詳細な説明
PRIMARY OBJECTIVES:
I. To determine and compare the feasibility and clinical toxicity of administering rF-B7.1 and rF-TRICOM vaccines to patients with accessible cutaneous, subcutaneous, or lymph node metastatic tumors.
II. To determine and compare the feasibility and clinical toxicity of administering rF-B7.1 and rF-TRICOM vaccines to patients with accessible visceral metastatic tumors.
III. To determine the optimal dose of rF-B7.1 and rF-TRICOM vaccine delivered by intra-tumoral injection.
IV. To compare the clinical responses and safety profile of patients with cutaneous tumors and visceral tumors who receive rF-B7.1 vaccine to similar patients receiving rF-TRICOM vaccine.
SECONDARY OBJECTIVES:
I. To establish evidence of host anti-tumor immune reactivity following intra-lesional vaccine administration and compare any differences between rF-B7.1 and rF-TRICOM in patients with cutaneous tumors and visceral tumors.
II. To evaluate the quality of life during vaccine administration.
OUTLINE: This is a randomized study with dose-escalation component. Patients are stratified according to tumor location (cutaneous, subcutaneous, or lymph node metastases vs visceral metastases). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive rF-B7.1 vaccine intratumorally on day 1.
ARM II: Patients receive fowlpox-TRICOM vaccine intratumorally on day 1.
Treatment in both arms repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional courses.
Three patients from the cutaneous disease (CD) stratum are treated at low-dose in each treatment arm. If no more than 1 of 6 patients experience dose-limiting toxicity (DLT), then 6 additional CD patients are randomized to high-dose treatment. If no more than 1 of these 6 patients experience DLT, then 12 patients from the visceral disease (VD) stratum are randomized to low-dose treatment. If no more than 2 of 12 VD patients experience DLT, then the next cohort of 12 VD patients is randomized to high-dose treatment. If 3 of the original 12 VD patients experience DLT, then 6 additional VD patients receive low-dose treatment. If no more than 3 of 18 patients experience DLT, then 12 VD patients receive high-dose treatment.
Quality of life is assessed at baseline, monthly during therapy, and then at the end of therapy.
Patients are followed every 3 months.
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 York
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New York、New York、アメリカ、10029
- Mount Sinai 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:
Histologically confirmed metastatic unresectable solid tumors
- Cutaneous, subcutaneous, lymph node, or visceral tumors that are accessible to imaging and injections
- No standard therapy available
At least 1 unidimensionally measurable lesion
- At least 20 mm for visceral lesions
- At least 10 mm for cutaneous, subcutaneous, and nodal lesions
No untreated or edematous metastatic brain lesions
- At least 6 weeks since prior surgery and/or radiotherapy for brain metastases and no evidence of disease or edema on CT scan or MRI
- No ascites or pleural effusions
- No leptomeningeal disease
- Performance status - ECOG 0-1
- More than 3 months
- Absolute granulocyte count at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
- No bleeding diathesis
- Bilirubin no greater than 1.5 mg/dL*
- SGOT/SGPT no greater than 2 times upper limit of normal (ULN)*
- Alkaline phosphatase no greater than 2 times ULN*
- No elevated PT or PTT
- No cirrhosis
- No active hepatitis
- No hepatic insufficiency
- Creatinine no greater than 2.0 mg/dL
- No renal insufficiency
- No chronic obstructive pulmonary disorder
- No active autoimmune disorders
- No active immunologically mediated disease (e.g., severe psoriasis, colitis, idiopathic thrombocytopenic purpura, multiple sclerosis, connective tissue disease, or active rheumatoid arthritis)
- No significant allergy or hypersensitivity to eggs
- No active seizure disorder
- No active or chronic infections
- No other significant medical disease that would preclude study participation
- No other malignancy within the past 5 years except stage I cervical cancer or basal cell carcinoma
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- More than 8 weeks since prior immunotherapy and recovered
- More than 4 weeks since prior chemotherapy and recovered
- At least 4 weeks since prior systemic corticosteroids
- No concurrent corticosteroids
- More than 2 weeks since prior radiotherapy and recovered
- No evidence of bone marrow toxicity from prior radiotherapy
- More than 4 weeks since prior surgery and recovered
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：ランダム化
- 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 |
|---|---|
|
実験的：Arm I (recombinant fowlpox-B7.1 vaccine)
Patients receive rF-B7.1 vaccine intratumorally on day 1.
|
相関研究
補助研究
他の名前：
Given intratumorally
他の名前：
|
|
実験的：Arm II (recombinant fowlpox-TRICOM vaccine)
Patients receive fowlpox-TRICOM vaccine intratumorally on day 1.
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相関研究
補助研究
他の名前：
腫瘍内投与
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 |
|---|---|---|
|
Percentages of the DLTEs
時間枠：12 weeks
|
Will be summarized and compared between arms, doses, and disease groups using Fisher's exact test.
|
12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of patients with any response (CR, PR, or SD)
時間枠：12 weeks
|
First, the proportion with any response (CR, PR or SD) will be compared to those with no response (PD).
Secondly, the proportion of any response (CR, PR or SD) compared to no response (PD) will be compared between the two treatment arms.
|
12 weeks
|
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Immune response
時間枠：12 weeks
|
Number of T-cells after treatment compared to those measured at baseline, and difference calculated as after-treatment minus baseline.
First comparison includes all subjects who completed treatment.
Mean change in T-Cells (final-baseline) tested against 0 with 2-tailed, 1-sample t-test, with alpha=.05.
Second analysis compares mean change in T-Cells between arms.
Performed as a 2-tailed, 2 independent samples t-test, with alpha=.05.
Third comparison is a sub-set analysis of patients with melanoma.
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12 weeks
|
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Change in quality of life, assessed using the FACT-G survey of emotional and functional well being
時間枠：Baseline to 12 weeks
|
A mean observed change in the FACT-G score will be tested against 0 (no change) for the group as a whole.
Secondly, the change in score will be compared between the two treatment arms.
The overall mean change will also be compared to historical controls either from the literature for cancer patients or to the values for non-subject cancer patients receiving other therapies.
Comparisons will be by t-test if the sample distribution meets parametric assumptions.
If not non-parametric procedures will be used.
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Baseline to 12 weeks
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協力者と研究者
捜査官
- 主任研究者：Howard Kaufman、Icahn School of Medicine at Mount Sinai
研究記録日
主要日程の研究
研究開始
一次修了 (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
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