NCT00090896

Brief Summary

RATIONALE: Biological therapies, such as CP-675,206, work in different ways to stimulate the immune system and stop tumor cells from growing. Vaccines may make the body build an immune response to kill tumor cells. Combining CP-675,206 with vaccine therapy may cause a stronger immune response and kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of CP-675,206 when given with vaccine therapy in treating patients with stage III or stage IV melanoma that cannot be removed with surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

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

April 1, 2004

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2004

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

August 3, 2020

Status Verified

August 1, 2012

Enrollment Period

4.3 years

First QC Date

September 7, 2004

Last Update Submit

July 30, 2020

Conditions

Melanoma (Skin)

Keywords

recurrent melanomastage III melanomastage IV melanoma

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody

    3 months

Study Arms (1)

CTLA4-Blocking Monoclonal Antibody

EXPERIMENTAL
Biological: maximum tolerated dose of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody

Interventions

maximum tolerated dose of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibodyBIOLOGICAL
CTLA4-Blocking Monoclonal Antibody

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed cutaneous or mucosal melanoma, meeting criteria for 1 of the following:
  • Unresectable stage III disease (locally relapsed unresectable, in-transit lesions, or unresectable draining nodes)
  • Stage IV disease, metastatic to 1 of the following sites:
  • Skin, subcutaneous tissues, or distant lymph nodes
  • Lung
  • Other visceral sites with lactic dehydrogenase ≤ 2 times upper limit of normal (unless due to liver stasis)
  • De novo metastatic disease allowed provided patient refused any standard or approved stage-appropriate therapy for melanoma
  • Measurable disease
  • HLA-A2.1 positive (HLA-A\*0201 by molecular subtyping)
  • MART-1-expressing tumor by reverse transcription polymerase chain reaction or immunohistochemistry
  • No symptomatic brain metastases and/or progression of CNS metastases within the past 4 weeks
  • Age 18 and over
  • Performance status ECOG 0-1 OR
  • Karnofsky 70-100%
  • HIV negative
  • +10 more criteria

You may not qualify if:

  • chronic hepatitis B or C
  • asthma
  • inflammatory bowel disease
  • celiac disease
  • history of chronic colitis or other chronic gastrointestinal conditions associated with diarrhea or bleeding
  • active chronic inflammatory or autoimmune disease, including any of the following:
  • Psoriasis
  • Rheumatoid arthritis
  • Multiple sclerosis
  • Hashimoto's thyroiditis
  • Addison's disease
  • Graves' disease
  • Systemic lupus erythematosus
  • active infection OR fever over 100° F within the past 3 days
  • allergy to study drugs
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Related Publications (1)

  • Comin-Anduix B, Sazegar H, Chodon T, Matsunaga D, Jalil J, von Euw E, Escuin-Ordinas H, Balderas R, Chmielowski B, Gomez-Navarro J, Koya RC, Ribas A. Modulation of cell signaling networks after CTLA4 blockade in patients with metastatic melanoma. PLoS One. 2010 Sep 15;5(9):e12711. doi: 10.1371/journal.pone.0012711.

    PMID: 20856802DERIVED

MeSH Terms

Conditions

Melanoma

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 Officials

  • Antoni Ribas, MD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2004

First Posted

September 8, 2004

Study Start

April 1, 2004

Primary Completion

July 1, 2008

Study Completion

October 1, 2009

Last Updated

August 3, 2020

Record last verified: 2012-08

Locations

US(1)