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
NCT00090896
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- 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)
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | 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 | |||
Official Title ICMJE | A Phase I, Open Label, Study To Evaluate The Safety And Immune Function Effects Of CP-675,206 In Combination With MART-1 Peptide-Pulsed Dendritic Cells In Patients With Advanced Melanoma | |||
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 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. | |||
Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is an open-label, dose-escalation study of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (CTLA4-blocking monoclonal antibody; CP-675,206). Patients receive CP-675,206 IV on days 0, 28, 60, and 90 and autologous dendritic cells pulsed with MART-1 antigen intradermally on days 0, 14, and 28. After day 120, patients with stable or responding disease may receive additional doses of CP-675,206 monthly in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of CP-675,206 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 3-21 patients will be accrued for this study within 3-10 months. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Melanoma (Skin) | |||
Intervention ICMJE | Biological: maximum tolerated dose of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody | |||
Study Arms ICMJE | Experimental: CTLA4-Blocking Monoclonal Antibody
Intervention: Biological: maximum tolerated dose of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody | |||
Publications * | Comin-Anduix B, Sazegar H, Chodon T, Matsunaga D, Jalil J, von Euw E, Escuin-Ordinas H, Balderas R, Chmielowski B, Gomez-Navarro J, Koya RC, Ribas A. Modulation of cell signaling networks after CTLA4 blockade in patients with metastatic melanoma. PLoS One. 2010 Sep 15;5(9):e12711. doi: 10.1371/journal.pone.0012711. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 18 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | October 2009 | |||
Actual Primary Completion Date | July 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00090896 | |||
Other Study ID Numbers ICMJE | CDR0000380840 UCLA-0312023 PFIZER-NRA3670003 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Jonsson Comprehensive Cancer Center | |||
Study Sponsor ICMJE | Jonsson Comprehensive Cancer Center | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | Jonsson Comprehensive Cancer Center | |||
Verification Date | August 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |