Status:
COMPLETED
Ticilimumab (CP-675,206) in Treating Patients With Stage IIIC or Stage IV Melanoma
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
Pfizer
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as ticilimumab (CP-675,206), can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help...
Detailed Description
OBJECTIVES: Primary * Determine the change in melanoma intratumoral infiltrates by cluster of differentiation 8 (CD8 positive) cytotoxic T lymphocytes in patients with stage IIIC or IV melanoma trea...
Eligibility Criteria
Inclusion
- Histologically confirmed melanoma that is surgically incurable and either:
- Stage IIIc melanoma including locally relapsed, satellite, in-transit lesions or bulky draining lymph node metastasis.
- Stage IV melanoma (M1a, M1b, M1c) with accessible lesions for biopsy.
- At least 2 lesions amenable for outpatient biopsies
- No restriction based on prior treatments
- Disease progression after the last dose of prior therapy
- A minimum of one measurable lesion defined as:
- Meeting the criteria for measurable disease according to Response Evaluation Criteria in Solid Tumors
- Skin lesion(s) selected as non-completely biopsied target lesions that can be accurately measured and recorded by color photography with a ruler to document the size of the target lesion(s).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate bone marrow and hepatic function determined within 30 days prior to enrollment, defined as:
- Absolute neutrophil count \> 1.0 x 10\^9 cells/L
- Platelets \> 90 x 10\^9 /L
- Hemoglobin \> 9 g/L
- Aspartate and alanine aminotransferases \< 2.5 x upper limit of normal (ULN) (\< 5 x ULN, if documented liver metastases are present)
- Total bilirubin \< 2 x ULN (except patients with documented Gilbert's syndrome)
- Must be willing and able to provide writing informed consent.
- Must be willing and able to accept at least two tumor biopsies.
- Must be willing and able to accept at least two leukapheresis procedures.
Exclusion
- Received treatment for cancer, including immunotherapy, within one month prior to dosing.
- Previous participation in Pfizer study A3671009: A Phase 3, Open Label, Randomized Comparative Study of CP-675,206 and Either Dacarbazine or Temozolomide in Patients with Advanced Melanoma
- Eligible for enrollment to Pfizer A3671008: A Phase 2, Open Label, Single Arm Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of CP-675,206 in Patients with Advanced Refractory and/or Relapsed Melanoma
- History of significant evidence of risk for chronic inflammatory or autoimmune disease. Patents will be eligible if prior autoimmune disease of the hypophysis was treated locally or have resulted in fibrotic damage requiring thyroid hormone replacement. Vitiligo will not be a basis for exclusion.
- History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis or any origin
- Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history or received systemic steroids within the last 4 weeks prior to enrollment
- Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol
- Clinically active brain metastases. Radiological documentation of absence of brain metastases at screening is required for all patients
- Pregnancy or breast-feeding.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00471887
Start Date
January 1 2007
End Date
March 1 2015
Last Update
October 26 2020
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781