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Chemotherapy Followed by Biological Therapy in Treating Patients With Stage IV Melanoma That Cannot be Treated With Surgery

2013年3月25日 更新者:Saint Francis Memorial Hospital

Treatment of Patients With Metastatic Malignant Melanoma With Chemobiotherapy With Temozolomide, GM-CSF, IL2, and Interferon Alfa-2b Phase II Trial

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as interleukin-2 and interferon alfa stimulate a person's white blood cells to kill cancer cells or may interfere with the growth of cancer cells. Combining chemotherapy with biological therapies may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of temozolomide followed by sargramostim, interleukin-2, and interferon alfa in treating patients who have stage IV melanoma that cannot be treated with surgery.

研究概览

详细说明

OBJECTIVES:

  • Determine the response rate, time to progression, and survival of patients with unresectable stage IV melanoma treated with temozolomide followed by sargramostim (GM-CSF), interleukin-2, and interferon alfa.
  • Determine the safety and tolerability of this regimen in this patient population.
  • Determine the changes in quality of life over time in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral temozolomide on days 1-5, and sargramostim (GM-CSF), interleukin-2, and interferon alfa subcutaneously on days 6-17. Treatment repeats every 28 days for 4-8 courses in the absence of disease progression or unacceptable toxicity. Patients with at least stable or responsive disease after 8 courses of therapy may receive additional therapy at investigators discretion.

Quality of life is assessed at baseline, every 8 weeks during study, and then at 1 month after study.

Patients are followed at 1 month, every 3 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 2 years.

研究类型

介入性

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • San Francisco、California、美国、94109
        • Saint Francis Memorial Hospital
      • Santa Monica、California、美国、90404
        • John Wayne Cancer Institute at Saint John's Health Center
    • Colorado
      • Aurora、Colorado、美国、80010
        • University of Colorado Cancer Center at University of Colorado Health Sciences Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS:

  • Histologically confirmed unresectable stage IV melanoma
  • Measurable metastatic disease
  • No uncontrolled brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • More than 12 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT and SGPT no greater than 3 times ULN
  • Alkaline phosphatase no greater than 3 times ULN

Renal:

  • BUN no greater than 1.5 times ULN
  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No significant cardiovascular disease

Other:

  • No non-malignant systemic disease
  • No acute infection requiring IV antibiotics
  • No alcohol or substance abuse
  • No other condition, disease, or history of other illness that would preclude study participation
  • No hypersensitivity, allergic reactions, or intolerance to study drugs
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy
  • No prior interleukin-2
  • No other concurrent immunotherapy
  • No concurrent investigational vaccines or immunomodulatory agents
  • No other concurrent growth factors

Chemotherapy:

  • At least 4 weeks since prior chemotherapy
  • No prior temozolomide
  • No other concurrent anticancer chemotherapy

Endocrine therapy:

  • No concurrent steroids (including corticosteroids)

Radiotherapy:

  • At least 4 weeks since prior radiotherapy

Surgery:

  • See Disease Characteristics
  • At least 3 weeks since prior major surgery

Other:

  • At least 30 days since prior immune-based therapy
  • No concurrent participation in other clinical trials with investigational drugs
  • No other concurrent anticancer drugs
  • No concurrent immunosuppressive therapy
  • No concurrent levamisole or cimetidine

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Lynn E. Spitler, MD、Northern California Melanoma Center at St. Francis Memorial Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

1999年12月1日

研究完成 (实际的)

2003年12月1日

研究注册日期

首次提交

2001年4月10日

首先提交符合 QC 标准的

2003年1月26日

首次发布 (估计)

2003年1月27日

研究记录更新

最后更新发布 (估计)

2013年3月26日

上次提交的符合 QC 标准的更新

2013年3月25日

最后验证

2004年3月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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