Zidovudine Plus Interleukin-2 and Ganciclovir in Treating Patients With AIDS-Related Primary Central Nervous System Lymphoma
A Phase II Trial Of Induction Therapy With Zidovudine, Interleukin-2, And Ganciclovir In The Treatment Of HIV Positive Primary Central Nervous System Lymphoma
RATIONALE: Antiviral drugs such as zidovudine and ganciclovir act against viruses and may be an effective treatment for HIV. Interleukin-2 may stimulate a person's white blood cells to kill lymphoma cells. Combining these treatments may be effective in treating AIDS-related primary central nervous system lymphoma.
PURPOSE: Phase II trial to study the effectiveness of combining zidovudine, ganciclovir, and interleukin-2 in treating patients who have AIDS-related primary central nervous system lymphoma.
調査の概要
詳細な説明
OBJECTIVES:
- Determine the safety and toxicity of zidovudine, interleukin-2, and ganciclovir in patients with AIDS related primary central nervous system lymphoma.
- Determine the response rate and overall survival of these patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive zidovudine (AZT) IV and ganciclovir IV over 1 hour every 12 hours on days 1-14. Patients also receive interleukin-2 (IL-2) IV every 12 hours on days 1-14 and a combination antiretroviral therapy consisting of nucleoside reverse transcriptase inhibitors (one of which must be AZT), nonnucleoside reverse transcriptase inhibitors, and protease inhibitors. AZT and ganciclovir treatment continues for an additional 7 days if partial response is achieved.
- Maintenance therapy: Patients receive IL-2 subcutaneously 3 times a week for 6 months. Patients also receive oral ganciclovir 3 times a day and combination antiretroviral therapy (AZT allowed, but not required). Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 1 year, every 3 months for 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 10-30 patients will be accrued for this study.
研究の種類
段階
- フェーズ2
連絡先と場所
研究場所
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Florida
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Miami、Florida、アメリカ、33136
- Sylvester Cancer Center, University of Miami
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Ohio
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Columbus、Ohio、アメリカ、43210
- Arthur G. James Cancer Hospital - Ohio State University
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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:
- HIV positive
Diagnosis of central nervous system lymphoma by one of the following means:
- Brain biopsy
- Thallium spectroscopy scan in conjunction with CT scan or MRI after failing to improve with at least 2 weeks of antitoxoplasmosis therapy
- Cerebral spinal fluid positive for Epstein Barr virus in conjunction with positive thallium spectroscopy scan
- Thallium spectroscopy scan demonstrating a thallium retention index greater than 1
- Documented intracranial space occupying lesion
- No systemic non-Hodgkin's lymphoma
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Absolute granulocyte count at least 1,000/mm3
- Platelet count at least 50,000/mm3
Hepatic:
- Bilirubin and SGOT no greater than 3 times upper limit of normal
- No major hepatic dysfunction as evidenced by encephalopathy, ascites, or varices
Renal:
- Creatinine clearance at least 60 mL/min
Other:
- No prior other malignancy within the past 5 years except carcinoma in situ of the cervix, basal cell carcinoma of the skin, or Kaposi's sarcoma not requiring systemic therapy
- No active uncontrolled infection except HIV or Epstein Barr virus
- No known allergy to E. coli derived products
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Concurrent corticosteroids allowed
Radiotherapy:
- Not specified
Surgery:
- Not specified
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:William J. Harrington, MD、University of Miami Sylvester Comprehensive Cancer Center
出版物と役立つリンク
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研究の完了 (実際)
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最初の投稿 (見積もり)
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詳しくは
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