Ticilimumab (CP-675,206) in Treating Patients With Stage IIIC or Stage IV Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Pfizer
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00471887
First received: May 8, 2007
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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 kill them or carry tumor-killing substances to them.

PURPOSE: This phase II trial is studying how well ticilimumab (CP-675,206) works in treating patients with stage IIIC or stage IV melanoma.


Condition Intervention Phase
Melanoma (Skin)
Biological: CP-675,206
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Open-Label, Single Arm Clinical Trial to Study the Mechanism of Action of CP-675,206 in Patients With In-Transit and Metastatic Melanoma Amenable to Repeated Outpatient Tumor Biopsies

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • Change in percent tumor infiltration by CD8 positive cytotoxic T lymphocytes [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumor evaluation for other immune cell infiltration and melanoma markers [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Differences in morphological and gene expression profiling studies in peripheral blood mononuclear cells [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Changes in the protein content in peripheral blood with an increase in proinflammatory cytokines and chemokines [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Overall response (complete or partial response) as measured by RECIST criteria [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Overall safety profile and tolerability as measured by NCI CTCAE v3.0 [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Enrollment: 34
Study Start Date: January 2007
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment-Single Arm
See intervention descriptions
Biological: CP-675,206
Patients will receive intravenous administration of CP-675,206 at a dose of 15mg/kg on Day 1 of an every 90 day cycles. For purposes of treatment visits and scheduling, each cycle is defined as a 90 day period. Patients may receive up to 8 dose (8 cycles) in a 24-month period until progression of disease or intolerable toxicity.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).
  • 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 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 Criteria:

  • 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 autoimmue 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471887

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Pfizer
Investigators
Principal Investigator: Antoni Ribas, MD Jonsson Comprehensive Cancer Center
Principal Investigator: John A. Glaspy, MD, MPH Jonsson Comprehensive Cancer Center
Principal Investigator: James S. Economou, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00471887     History of Changes
Other Study ID Numbers: CDR0000543416, P30CA016042, UCLA-0606093-01, PFIZER-UCLA-0606093-01
Study First Received: May 8, 2007
Last Updated: August 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Jonsson Comprehensive Cancer Center:
stage III melanoma
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Tremelimumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014