Lenalidomide and Dacarbazine (DTIC) in Patients With Metastatic Melanoma

NCT00412581 | Completed Phase 1

• 1 other identifier: 2004-0487
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Conditions

Melanoma

Keywords

Melanoma; Lenalidomide; Dacarbazine; CC-5013; Revlimid; DTIC

Outcome Measures

Primary Outcomes (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.

  2.5 Years

Study Arms (1)

Lenalidomide + Dacarbazine

EXPERIMENTAL

Drug: Lenalidomide; Drug: Dacarbazine

Interventions

Lenalidomide DRUG

25 mg by mouth daily for 2 weeks, followed by 1 week of rest.

Also known as: CC-5013, Revlimid

Lenalidomide + Dacarbazine

Dacarbazine DRUG

600 mg/m\^2 intravenously on Day 1 of every study cycle.

Also known as: DTIC

Lenalidomide + Dacarbazine

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Celgene Corporation: collaborator

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Melanoma

Interventions

Lenalidomide; Dacarbazine

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; Triazenes; Imidazoles; Azoles

Study Officials

• Agop Y. Bedikian, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 14, 2006
• First Posted: December 18, 2006
• Study Start: September 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: April 29, 2016

Record last verified: 2012-07

Locations

US (1)