Status:
COMPLETED
Lenalidomide and Dacarbazine (DTIC) in Patients With Metastatic Melanoma
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Celgene Corporation
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Primary Objectives: 1\. 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 L...
Detailed Description
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 syste...
Eligibility Criteria
Inclusion
- 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 0,1,2.
- 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.
Exclusion
- 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 1.
- Prior \>/= grade-2 allergic reaction to thalidomide.
- Prior desquamating rash while taking thalidomide.
- Any prior use of CC-5013.
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00412581
Start Date
September 1 2005
End Date
March 1 2008
Last Update
April 29 2016
Active Locations (1)
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1
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030