CP-675,206 (CTLA4-Blocking Monoclonal Antibody) Combined With Dendritic Cell Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed With Surgery

Completed · Phase 1

Conditions studied: Melanoma (Skin)

In brief

RATIONALE: Biological therapies, such as CP-675,206, work in different ways to stimulate the immune system and stop tumor cells from growing. Vaccines may make the body build an immune response to kill tumor cells. Combining CP-675,206 with vaccine therapy may cause a stronger immune response and kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of CP-675,206 when given with vaccine therapy in treating patients with stage III or stage IV melanoma that cannot be removed with surgery.

Key facts

Study ID

NCT00090896

Run by

Jonsson Comprehensive Cancer Center

People needed

18

Starts

2004-04-01

Expected to finish

2009-10-01

Last updated by the study team

2020-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed cutaneous or mucosal melanoma, meeting criteria for 1 of the following:
• Unresectable stage III disease (locally relapsed unresectable, in-transit lesions, or unresectable draining nodes)
• Stage IV disease, metastatic to 1 of the following sites:
• Skin, subcutaneous tissues, or distant lymph nodes
• Lung
• Other visceral sites with lactic dehydrogenase ≤ 2 times upper limit of normal (unless due to liver stasis)
• De novo metastatic disease allowed provided patient refused any standard or approved stage-appropriate therapy for melanoma
• Measurable disease
• HLA-A2.1 positive (HLA-A*0201 by molecular subtyping)
• MART-1-expressing tumor by reverse transcription polymerase chain reaction or immunohistochemistry
• No symptomatic brain metastases and/or progression of CNS metastases within the past 4 weeks
• Age 18 and over
• Performance status ECOG 0-1 OR
• Karnofsky 70-100%
• HIV negative
• Negative pregnancy test
• Fertile patients must use effective barrier contraception during and for 3 months after study participation
• More than 30 days since prior immunotherapy for metastatic, relapsed, or primary melanoma
• More than 30 days since prior chemotherapy for metastatic, relapsed, or primary melanoma
• More than 4 weeks since prior corticosteroids
• More than 30 days since prior radiotherapy for metastatic, relapsed, or primary melanoma
• More than 30 days since prior surgery for metastatic, relapsed, or primary melanoma.
• More than 30 days since other prior therapy for metastatic, relapsed, or primary melanoma
• More than 14 days since prior anti-infective therapy
• More than 4 weeks since prior immune suppressive therapy (e.g., cyclosporine)

You may not qualify if…

• chronic hepatitis B or C
• asthma
• inflammatory bowel disease
• celiac disease
• history of chronic colitis or other chronic gastrointestinal conditions associated with diarrhea or bleeding
• active chronic inflammatory or autoimmune disease, including any of the following:
• Psoriasis
• Rheumatoid arthritis
• Multiple sclerosis
• Hashimoto's thyroiditis
• Addison's disease
• Graves' disease
• Systemic lupus erythematosus
• active infection OR fever over 100° F within the past 3 days
• allergy to study drugs
• pregnant
• symptomatic seizures
• other medical problem that would preclude study participation
• prior melanoma immunotherapy containing MART-1 antigen
• prior anti-T-cell therapy
• prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (CP-675,206)
• organ allografts requiring long-term immune suppressive therapy

Where it is running

• Jonsson Comprehensive Cancer Center at UCLA — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.