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CP-675,206 In Patients With Advanced Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00086489
Recruitment Status : Completed
First Posted : July 5, 2004
Last Update Posted : June 6, 2012
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to assess the efficacy, safety, and tolerability of monoclonal antibody therapy using 2 regimens for the treatment of advanced melanoma

Condition or disease Intervention/treatment Phase
Malignant Melanoma Drug: CP-675,206 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Open Label, Non-Randomized, Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics, Immune Function Effects, And Efficacy Of Multiple Doses Of CP-675,206 In Patients With Advanced Melanoma, And Phase 2, Open Label, Randomized Study To Evaluate the Efficacy, Safety, Tolerability And Pharmacokinetics Of 2 Regimens Of CP-675,206 In Patients With Advanced Melanoma.
Study Start Date : August 2003
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: 10 mg/kg
pts treated at 10 mg/kg dose level on a monthly regimen
Drug: CP-675,206
pts treated at 10 mg/kg dose level on a monthly regimen

Experimental: 15 mg/kg
pts treated at 15 mg/kg dose level on a quarterly regimen
Drug: CP-675,206
pts treated at 15 mg/kg dose level on a quarterly regimen

Primary Outcome Measures :
  1. Safety [ Time Frame: At every scheduled visit for a maximum of 2 years from first dose of study drug ]
  2. Tumor response [ Time Frame: Assessed every 2-3 months up to 2 years from first dose of study drug ]

Secondary Outcome Measures :
  1. Monitor for human anti-human antibodies at the end of the study [ Time Frame: Pre-dose (Cycle 1 only) and end of study ]
  2. Explore genetic influences on safety and or immune response [ Time Frame: Pre-dose, Cycle 1 ]
  3. Assess PK during treatment [ Time Frame: All cycles as pre-specified in protocol ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed: Stage III (AJCC 6th edition)xxl unresectable melanoma, with measurable disease (either locally relapsed unresectable, in-transit lesions or unresectable draining nodes) or Stage IV melanoma, including:
  • Metastasis to skin, subcutaneous tissues or distant lymph nodes, or
  • Metastasis to lungs, or
  • Metastasis to all other visceral sites with either LDH <= ULN (upper limit of normal) or a single site of metastasis
  • Note: Patients with melanoma of ocular origin will be considered ineligible
  • Documented progressive disease following adjuvant therapy, localized therapy or other therapy for metastatic disease
  • Measurable disease defined by at least one target lesion that can be accurately measured and whose size is at least 1.0 cm (by spiral CT) or 2.0 cm (by conventional techniques) in its longest diameter
  • ECOG performance status of 0 or 1 Life expectancy of > 3 months
  • Either gender, aged 18 years and above
  • Adequate bone marrow, hepatic, and renal functions determined within 2 weeks prior to starting therapy, defined as:
  • Absolute neutrophil count >= 1.5 x 10(9)cells/L
  • Platelets >= 100 x 10(9)/L
  • Hemoglobin >= 10 g/dL
  • Aspartate and alanine aminotransferases (AST, ALT) <= 2.5 x ULN (<= 5 x ULN, if documented liver metastases are present)
  • Total bilirubin <= 1.5 x ULN
  • Creatinine <= 1.5 x ULN
  • Patients must have recovered from all prior treatment related toxicities, to baseline status, or a CTC grade of 0 or 1. Post-surgical pain shall not be considered a basis for exclusion.
  • Females must either be not of childbearing potential [surgically sterilized, which includes tubal ligation, or at least 2 years postmenopausal; not breastfeeding], or practicing 1 form of approved contraception for at least three months prior to entry into the study with 1 of the following methods: (a) oral contraceptives, (b) intrauterine device, (c) implanted contraceptive (such as Norplant®), (d) injected contraceptives (such as Depo-Provera®), (e) diaphragm, (f) sexual partner must use condom or be surgically sterilized, or (g) sexually inactive. Females of childbearing potential must be instructed to avoid pregnancy during study participation. Negative serum or urine pregnancy test must be documented during screening evaluation.
  • Must be willing and able to provide written informed consent.

Exclusion Criteria:

  • Received immunotherapy for cancer within one month prior to the start of screening
  • Patients previously treated on this protocol
  • History of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (e.g. Addison's disease, asthma, celiac disease, multiple sclerosis, Graves Disease, Hashimoto's thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, etc.)
  • Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history.
  • History of autoimmune colitis or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any origin.
  • Pregnant or lactating women.
  • Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
  • Diagnosed or suspected brain metastases. Patients with past history of brain metastases but with no radiologic evidence within 12 weeks prior to enter into the protocol will be eligible.
  • Any serious uncontrolled medical disorder or active infection, which would impair their ability to receive study treatment.
  • Coexisting malignancies except for basal or squamous cell carcinoma of the skin.
  • Received any prior CTLA4 inhibiting agent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00086489

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United States, California
Research Site
Los Angeles, California, United States, 90095
United States, Florida
Research Site
Tampa, Florida, United States, 33612
United States, Illinois
Research Site
Chicago, Illinois, United States, 60637-1460
United States, Michigan
Research Site
Ann Arbor, Michigan, United States, 48109-0008
Research Site
Ann Arbor, Michigan, United States, 48109-0843
United States, Pennsylvania
Research Site
Pittsburgh, Pennsylvania, United States, 15232-1305
Research Site
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Research Site
Nashville, Tennessee, United States, 37232
United States, Texas
Research Site
Houston, Texas, United States, 77030
Sponsors and Collaborators
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: AstraZeneca Identifier: NCT00086489    
Other Study ID Numbers: A3671002
First Posted: July 5, 2004    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: June 2012
Keywords provided by AstraZeneca:
metastatic melanoma
multiple dose
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents
Antineoplastic Agents, Immunological