CP-675,206 In Patients With Advanced Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00086489
First received: July 1, 2004
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Malignant Melanoma
Drug: CP-675,206
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Safety [ Time Frame: At every scheduled visit for a maximum of 2 years from first dose of study drug ] [ Designated as safety issue: No ]
  • Tumor response [ Time Frame: Assessed every 2-3 months up to 2 years from first dose of study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Monitor for human anti-human antibodies at the end of the study [ Time Frame: Pre-dose (Cycle 1 only) and end of study ] [ Designated as safety issue: No ]
  • Explore genetic influences on safety and or immune response [ Time Frame: Pre-dose, Cycle 1 ] [ Designated as safety issue: No ]
  • Assess PK during treatment [ Time Frame: All cycles as pre-specified in protocol ] [ Designated as safety issue: No ]

Enrollment: 118
Study Start Date: August 2003
Study Completion Date: May 2009
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  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: NCT00086489

Locations
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
Research Site
Pittsburgh, Pennsylvania, United States, 15232-1305
United States, Tennessee
Research Site
Nashville, Tennessee, United States, 37232
United States, Texas
Research Site
Houston, Texas, United States, 77030
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00086489     History of Changes
Other Study ID Numbers: A3671002
Study First Received: July 1, 2004
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
metastatic melanoma
multiple dose

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

ClinicalTrials.gov processed this record on July 23, 2014