Lenalidomide and Dacarbazine (DTIC) in Patients With Metastatic Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00412581
Recruitment Status : Completed
First Posted : December 18, 2006
Last Update Posted : April 29, 2016
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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 Lenalidomide in patients with metastatic malignant melanoma previously untreated with systemic chemotherapy.

Secondary Objectives:

  1. To define the recommended Phase II doses of Lenalidomide and DTIC when administered as combination therapy.
  2. To evaluate the safety and toxicity profile of combination Lenalidomide plus DTIC.
  3. To evaluate the preliminary efficacy of combination Lenalidomide plus DTIC.

Condition or disease Intervention/treatment Phase
Melanoma Drug: Lenalidomide Drug: Dacarbazine Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : September 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Lenalidomide + Dacarbazine Drug: Lenalidomide
25 mg by mouth daily for 2 weeks, followed by 1 week of rest.
Other Names:
  • CC-5013
  • Revlimid
Drug: Dacarbazine
600 mg/m^2 intravenously on Day 1 of every study cycle.
Other Name: DTIC

Primary Outcome Measures :
  1. 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. [ Time Frame: 2.5 Years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00412581

United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
Principal Investigator: Agop Y. Bedikian, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00412581     History of Changes
Other Study ID Numbers: 2004-0487
First Posted: December 18, 2006    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: July 2012

Keywords provided by M.D. Anderson Cancer Center:

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action