Phase I Safety Study of the Combination of Lenalidomide and Dacarbazine (DTIC) in Patients With Metastatic Malignant Melanoma Previously Untreated With Systemic Chemotherapy (CC-5013-MEL-003)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- To find out the highest safe dose of DTIC that can be given in combination with a steady dose of Lenalidomide, to patients with malignant melanoma that has spread to other parts of the body and has not been treated with chemotherapy.
研究概览
简要总结
Primary Objectives:
- To determine the maximum tolerated dose (MTD) of intravenous DTIC during the first 2 cycles (6 weeks) of treatment when administered in combination with a fixed dose of oral Lenalidomide in patients with metastatic malignant melanoma previously untreated with systemic chemotherapy.
Secondary Objectives:
- To define the recommended Phase II doses of Lenalidomide and DTIC when administered as combination therapy.
- To evaluate the safety and toxicity profile of combination Lenalidomide plus DTIC.
- To evaluate the preliminary efficacy of combination Lenalidomide plus DTIC.
详细描述
Lenalidomide is related to a drug called Thalidomide, which is not widely used because of certain side effects. Lenalidomide belongs to a family of drugs that work by acting on the body's immune system, so that it makes more "anti-inflammatory" cells. This type of cell is normally found in the body and is believed to help reduce the growth of cancer cells and slow down the production of new cancer cells.
DTIC is an anti-cancer drug. It is designed to cause cancer cell death by creating DNA breaks in the nucleus of the cells.
Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will be asked questions about your medical history, and you will have a complete physical exam, which will included measurements of your temperature, pulse, blood pressure, respiratory (breathing) rate, weight and height. You will be asked about any surgeries you have had and any medications you are taking. Your ability to perform daily activities will be checked through simple physical tests (such as walking or squeezing a ball). You will also have blood drawn (about 1 tablespoon) for routine tests and tests to measure your thyroid hormones.
You will have an electrocardiogram (ECG - a test that measures the electrical activity of the heart). You will have a chest x-ray and CT scans of the chest, abdomen and pelvis (below the waist). You will be required to have a MRI or CT scan of the brain. If your doctor feels it is necessary, you may need CT scans of the head and neck or a bone scan. To perform the bone scan, a small dose of radioactive technetium is administered intravenously (IV--through a needle in your vein). The technetium will collect in the areas of bone involved with metastatic cancer to "light up" these areas on the bone scan. The results of these tests will show if you are eligible to participate in the study. Women who are able to have children must have a negative blood pregnancy test.
If you are still eligible to take part in the study, you will begin study treatment. You will take Lenalidomide by mouth every day for 2 weeks, followed by 1 week of "rest." This 21-day period is referred to as one "study cycle." You should only take Lenalidomide on an empty stomach. You should fast for 1 hour before and after taking Lenalidomide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study: Understand and voluntarily sign an informed consent document.
- •Age >/= 18 years at the time of signing Informed Consent.
- •Be able to adhere to the study visit schedule and other protocol requirements.
- •Histological documentation of malignant melanoma with evidence of metastatic disease.
- •For the 10 patients enrolled at the MTD, at least one measurable lesion must be present.
- •ECOG performance status of 0,1,
- •Laboratory tests within these ranges: a) Absolute neutrophil count >/= 1,500/microliter b) Platelet count >/= 100,000/microliter, c) Serum creatinine </= 1.5 mg/dL, d) Total bilirubin </= 1.5 mg/dL, e) AST (SGOT)/ALT (SGPT) </= 2 x upper limit of normal (ULN)
- •Females of childbearing potential (FCBP)† must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study. FCBP must have two negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to starting study drug. Male Subjects: Must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy.
- •All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to < or = to grade 1 (NCI CTCAE v3.0). (not listed in protocol synopsis)
- •Patients must be able to take medications orally.
排除标准
- •The presence of any of the following will exclude a patient from study enrollment: Pregnant or lactating females.
- •Any serious medical condition, including psychiatric illnesses that will prevent the patient from signing the informed consent or place the patient at an unacceptable risk if he/she participates in the study.
- •Prior treatment with systemic chemotherapy. Patients who have received prior immunotherapy, including thalidomide, or radiotherapy remain eligible. Lesions within a prior field of radiation may only be used as indicator lesions if there has been evidence of disease progression at that site.
- •Prior history of malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the patient has been free of the disease for at least 3 years.
- •Use of thalidomide or biologic response modifier therapy within 14 days of Day 1, Cycle
- •Prior >/= grade-2 allergic reaction to thalidomide.
- •Prior desquamating rash while taking thalidomide.
- •Any prior use of CC-
- •Concurrent use of any other anti-cancer agents.
- •Radiation or surgical treatment of melanoma within 28 days of starting study treatment.
- •Active infection.
- •Central nervous system (CNS) metastases.
- •Patients with >/= grade-2 neuropathy.
- •Patients with known HIV positivity or AIDS-related illness.
研究组 & 干预措施
Lenalidomide + Dacarbazine
干预措施: Lenalidomide (Drug)
Lenalidomide + Dacarbazine
干预措施: Dacarbazine (Drug)
结局指标
主要结局
To find out the highest safe dose of DTIC that can be given in combination with a steady dose of Lenalidomide, to patients with malignant melanoma that has spread to other parts of the body and has not been treated with chemotherapy.
时间窗: 2.5 Years
次要结局
未报告次要终点