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

Last updated date
Study Location
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Melanoma (Skin)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Melanoma (Skin)Ticilimumab (CP-675,206) in Treating Patients With Stage IIIC or Stage IV Melanoma
NCT00471887
  1. Los Angeles, California
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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

  • Determine the safety and maximum tolerated dose of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (CTLA4-blocking monoclonal antibody; CP-675,206) administered with autologous dendritic cells pulsed with MART-1 antigen in patients with unresectable stage III or stage IV melanoma.
  • Determine the biological activity and immune effects of this regimen in these patients.

Secondary

  • Correlate CTLA4 genotype with safety of this regimen and/or immune response in these patients.
  • Determine, preliminarily, the efficacy of this regimen, in terms of clinical benefit rate, in these patients.

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
 (submitted: May 18, 2010)
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:

  • 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 Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Chair:Antoni Ribas, MDJonsson Comprehensive Cancer Center
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