Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer
Vaccination of Non-Small Cell Lung Cancer Patients Against Mutated K-Ras: A Pilot Trial
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy and sargramostim in treating patients who have non-small cell lung cancer.
調査の概要
詳細な説明
OBJECTIVES:
- Determine whether a specific T-cell response can be induced in patients with stage IB-IV non-small cell lung cancer treated with mutant K-ras peptide vaccine (limited to the specific K-ras peptide mutation in their tumors) and sargramostim (GM-CSF).
- Determine whether skin test reactivity or HLA type correlates with the induction of anti-K-ras immune responses in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients receive sargramostim (GM-CSF) intradermally (ID) on days 1-10 beginning a maximum of 6 months after complete surgical resection. Patients receive mutant K-ras peptide vaccine (limited to the specific K-ras mutation in their tumors) ID on day 7. Treatment repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 and 12 weeks.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 18 months.
研究の種類
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
New York
-
New York、New York、アメリカ、10021
- Memorial Sloan-Kettering Cancer Center
-
-
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 proven stage IB-IV non-small cell lung cancer
- Non-squamous cell histology only
- Must have undergone curative surgery within the past 6 months and must be free of recurrence
- Tumor must demonstrate a specific K-ras mutation at codon 12 for which a vaccine preparation is available
PATIENT CHARACTERISTICS:
Age:
- Over 17
Performance status:
- Karnofsky 70-100%
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Not specified
Renal:
- Not specified
Cardiovascular:
- No New York Heart Association class III or IV heart disease
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No concurrent medical condition that would preclude compliance or immunologic response to study treatment
- No other serious concurrent medical condition
- No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the uterine cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 3 weeks since prior postoperative chemotherapy and recovered
Endocrine therapy:
- No concurrent systemic steroids
- Concurrent inhaled steroids allowed
Radiotherapy:
- No prior radiotherapy to spleen
- At least 3 weeks since prior postoperative radiotherapy and recovered
Surgery:
- See Disease Characteristics
- No prior splenectomy
Other:
- No concurrent immunosuppressive drugs or antiinflammatory 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
協力者と研究者
捜査官
- スタディチェア：Lee M. Krug, MD、Memorial Sloan Kettering 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 (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
- 99-028
- CDR0000067783 (レジストリ識別子：PDQ (Physician Data Query))
- NCI-G00-1775
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。