NCT00086489

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2003

Longer than P75 for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 5, 2004

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

June 6, 2012

Status Verified

June 1, 2012

Enrollment Period

3.8 years

First QC Date

July 1, 2004

Last Update Submit

June 5, 2012

Conditions

Malignant Melanoma

Keywords

metastatic melanomamultiple dose

Outcome Measures

Primary Outcomes (2)

  • Safety

    At every scheduled visit for a maximum of 2 years from first dose of study drug

  • Tumor response

    Assessed every 2-3 months up to 2 years from first dose of study drug

Secondary Outcomes (3)

  • Monitor for human anti-human antibodies at the end of the study

    Pre-dose (Cycle 1 only) and end of study

  • Explore genetic influences on safety and or immune response

    Pre-dose, Cycle 1

  • Assess PK during treatment

    All cycles as pre-specified in protocol

Study Arms (2)

10 mg/kg

EXPERIMENTAL

pts treated at 10 mg/kg dose level on a monthly regimen

Drug: CP-675,206

15 mg/kg

EXPERIMENTAL

pts treated at 15 mg/kg dose level on a quarterly regimen

Drug: CP-675,206

Interventions

CP-675,206DRUG

pts treated at 10 mg/kg dose level on a monthly regimen

10 mg/kg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +3 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Research Site

Los Angeles, California, 90095, United States

Location

Research Site

Tampa, Florida, 33612, United States

Location

Research Site

Chicago, Illinois, 60637-1460, United States

Location

Research Site

Ann Arbor, Michigan, 48109-0008, United States

Location

Research Site

Ann Arbor, Michigan, 48109-0843, United States

Location

Research Site

Pittsburgh, Pennsylvania, 15232-1305, United States

Location

Research Site

Pittsburgh, Pennsylvania, 15232, United States

Location

Research Site

Nashville, Tennessee, 37232, United States

Location

Research Site

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Comin-Anduix B, Lee Y, Jalil J, Algazi A, de la Rocha P, Camacho LH, Bozon VA, Bulanhagui CA, Seja E, Villanueva A, Straatsma BR, Gualberto A, Economou JS, Glaspy JA, Gomez-Navarro J, Ribas A. Detailed analysis of immunologic effects of the cytotoxic T lymphocyte-associated antigen 4-blocking monoclonal antibody tremelimumab in peripheral blood of patients with melanoma. J Transl Med. 2008 May 1;6:22. doi: 10.1186/1479-5876-6-22.

    PMID: 18452610DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

tremelimumab

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2004

First Posted

July 5, 2004

Study Start

August 1, 2003

Primary Completion

May 1, 2007

Study Completion

May 1, 2009

Last Updated

June 6, 2012

Record last verified: 2012-06

Locations

US(9)