Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

CC-5013 in Treating Patients With Progressive or Relapsed Metastatic Melanoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Treatment	Completed	18 and over	NCI, Pharmaceutical / Industry	UCLA-0210051 CELGENE-CDC-501-MEL-001, MSKCC-03026, NCT00060281

Objectives

1. Compare the efficacy of 2 dosing schedules of CC-5013, in terms of overall survival, in patients with previously treated metastatic malignant melanoma that is refractory or has relapsed.
2. Compare the safety of these dose schedules, in terms of type, frequency, and severity of adverse events and relationship of adverse events to study therapy, in these patients.
3. Compare the time to progression and response rate of patients treated with these dose schedules.

Entry Criteria

Disease Characteristics:

• Histologically confirmed metastatic malignant melanoma
  • Stage IV disease



• Relapsed or refractory to standard therapy for metastatic disease (i.e., dacarbazine, interleukin-2, interferon alfa, and/or interferon beta)



• At least 1 measurable lesion



• No newly diagnosed brain metastases within the past 4 weeks

Prior/Concurrent Therapy:

Biologic therapy

• See Disease Characteristics
• No prior CC-5013
• No concurrent thalidomide
• No concurrent sargramostim (GM-CSF)

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• At least 4 weeks since prior hormonal therapy

Radiotherapy

• At least 4 weeks since prior radiotherapy
• No concurrent radiotherapy

Surgery

• Not specified

Other

• At least 4 weeks since other prior cancer therapy
• More than 4 weeks since prior experimental drugs or therapies
• No other concurrent anticancer agents or treatment
• No other concurrent investigational agents

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin no greater than 1.5 mg/dL
• AST and ALT no greater than 2 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present)
• No hepatitis A, B, or C

Renal

• Creatinine no greater than 1.5 mg/dL

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• No active brain disease within the past 4 weeks
• No known hypersensitivity to thalidomide
• No development of erythema nodosum (if characterized by a desquamating rash while taking thalidomide or similar drugs)
• No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude giving informed consent
• No other condition, including laboratory abnormalities, that would preclude study participation or confound interpretation of results

Expected Enrollment

A total of 274 patients (137 patients per treatment arm) will be accrued for this study within 1 year.

Outline

This is a randomized, double-blind, multicenter study. Patients are stratified according to ECOG performance status (0 and 1 vs 2), metastatic sites of disease (M1 vs M2 vs M3), and lactic dehydrogenase (normal vs elevated). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive a lower dose of oral CC-5013 and oral placebo once daily on days 1-28.



• Arm II: Patients receive a higher dose of oral CC-5013 and oral placebo once daily on days 1-21, then receive 2 oral placebos once daily on days 22-28.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

John Glaspy, MD, MPH, Principal investigator		Ph: 310-794-4955; 888-798-0719

Registry Information
Official Title		Multicenter, Randomized, Controlled, Double-Blind, Parallel-Group Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects with Metastatic Malignant Melanoma Whose Disease has Progressed on Treatment with DTIC, IL-2, IFN-Alpha and/or IFN-Beta Based Therapy
Trial Start Date		2003-03-24
Registered in ClinicalTrials.gov		NCT00060281
Date Submitted to PDQ		2003-03-24
Information Last Verified		2004-09-08
NCI Grant/Contract Number		P30-CA16042

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