Status:
COMPLETED
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
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
Pfizer
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 kil...
Detailed Description
OBJECTIVES: Primary * Determine the safety and maximum tolerated dose of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (CTLA4-blocking monoclonal antibody; CP-675,206) adminis...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00090896
Start Date
April 1 2004
End Date
October 1 2009
Last Update
August 3 2020
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781