Lenalidomide and Dacarbazine (DTIC) in Patients With Metastatic Melanoma
This study has been completed.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
First received: December 14, 2006
Last updated: April 28, 2016
Last verified: July 2012
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.
- 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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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)
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2008 (Final data collection date for primary outcome measure)
Experimental: Lenalidomide + Dacarbazine
25 mg by mouth daily for 2 weeks, followed by 1 week of rest.
600 mg/m^2 intravenously on Day 1 of every study cycle.
Other Name: DTIC
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00412581
|U.T.M.D. Anderson Cancer Center
|Houston, Texas, United States, 77030 |
M.D. Anderson Cancer Center
||Agop Y. Bedikian, MD
||M.D. Anderson Cancer Center
||M.D. Anderson Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 14, 2006
||April 28, 2016
||United States: Food and Drug Administration
Keywords provided by M.D. Anderson Cancer Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 26, 2016
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Physiological Effects of Drugs
Angiogenesis Modulating Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action