Study of the Combination of Lenalidomide and DTIC (Dacarbazine) in Patients With Metastatic Malignant Melanoma Previously Untreated With Systemic Chemotherapy

NCT00179608 | Completed Phase 1

• 1 other identifier: CC-5013-MEL-003
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine the MDT of intravenous DTIC when administered in combination with a fixed dose of oral lenalidomide in subjects with metastatic malignant melanoma previously untreated with systemic chemotherapy. This study will evaluate the safety and preliminary efficacy of the combination of lenalidomide and DTIC. Subjects will be receive lenalidomide for 14 consecutive days and DTIC on day one of each 21 day cycle.

Conditions

Malignant Melanoma

Keywords

CC-5013; CC5013; celgene; Melanoma; Revlimid; Metastatic Malignant Melanoma; Lenalidomide

Outcome Measures

Primary Outcomes (1)

• To determine MTD of intravenous DTIC during the first 2 cycles (6 wks) of treatment

Secondary Outcomes (2)

• To evaluate the safety profile of combination lenalidomide plus DTIC, the preliminary efficacy of combination lenalidomide plus DTIC

• To define the recommended phase II doses of lenalidomide and DTIC when administered as combination therapy.

Interventions

CC-5013 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand and voluntarily sign an informed consent document
• Age greater than or equal to 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 (see Appendix II)
• ECOG performance status of 0, 1 or 2 (see Appendix I)
• Laboratory tests within these ranges:
• Absolute neutrophil count greater than or equal to 1,500/uL
• Platelet count greater than or equal to 100,000/uL
• Serum creatinine less than or equal to 1.5 mg/dL
• Total bilirubin less that or equal to 1.5 mg.dL
• AST (SGOT) / ALT (SGPT) less than or equal to to 2 times upper limit of normal (ULN)
• Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug.
• In addition, sexually active WCBP must agree to use at least two methods of adequate contraceptive (oral, injectable, or implantable hormonal contraceptive, tubal ligation, intra-uterine device, barrier contraceptive with spermicide, contraceptive skin patch or vasectomized partner) while on study drug
• All acute adverse effects (excluding alopecia of any prior therapy must have resolved to less than or equal to grade 1 (NCI CTCAE v3.0)

You may not qualify if:

• 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 greater than or equal to grade 2 allergic reaction to thalidomide
• Prior desquamating rash while taking thalidomide
• Any prior use of lenalidomide
• 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

Sponsors & Collaborators

• Celgene: lead
• Prologue Research International: collaborator

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Related Publications (1)

• Hwu WJ, Knight RD, Patnana M, Bassett R, Papadopoulos NE, Kim KB, Hwu P, Bedikian A. Phase I safety study of lenalidomide and dacarbazine in patients with metastatic melanoma previously untreated with systemic chemotherapy. Melanoma Res. 2010 Dec;20(6):501-6. doi: 10.1097/CMR.0b013e32833faf18.

  PMID: 20859231 BACKGROUND

MeSH Terms

Conditions

Melanoma

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: September 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: November 8, 2019

Record last verified: 2019-11

Locations

US (1)