Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by AHS Cancer Control Alberta.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Rachel Syme, Alberta Health Services
ClinicalTrials.gov Identifier:
NCT01034787
First received: December 15, 2009
Last updated: January 18, 2012
Last verified: September 2011
  Purpose

This is a Phase 2, multi-center, open-label study in patients with surgically incurable stage III or IV uveal melanoma who have not received prior immunotherapy. CP-675,206 is thought to stimulate patients' immune systems to attack their tumors. CP-675,206 has been shown to induce durable tumor responses in patients with metastatic melanoma in phase 1 and phase 2 clinical studies.


Condition Intervention Phase
Uveal Melanoma
Drug: CP-675,206
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Phase II Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • Progression-free survival at 6 months after initiation of CP-675,206 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective tumor response [ Time Frame: overall ] [ Designated as safety issue: No ]
  • Durable response, defined as an objective tumor response that last 6 or more months [ Time Frame: 6 or more months ] [ Designated as safety issue: No ]
  • Median survival and overall survival [ Time Frame: overall ] [ Designated as safety issue: No ]
  • Adverse events and tolerability [ Time Frame: overall ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 32
Study Start Date: January 2010
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open Label CP-675,206 Drug: CP-675,206
Patients will receive CP-675,206 at 15 mg/kg administered intravenously on day 1 of ever 90 cycle for up to 4 cycles or until progression or intolerance of toxicity. Tumor assessments will be done ever 3 months. Additional scans will be done if clinically indicated.l

  Eligibility

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

Inclusion Criteria:

  • Histologically confirmed uveal melanoma including choroidal melanoma, iris melanoma, and ciliary body melanoma
  • Patients may either have measurable disease or non-measurable disease.
  • Biopsies from a readily accessible site of disease on study enrollment are mandatory in principle. Waivers will be granted if there are no accessible lesions. The collection of a representative block of the diagnostic tumour tissue (if available) is mandatory.
  • ECOG performance status of 0 or 1
  • Age 18 years or older
  • Adequate bone marrow, hepatic, and renal function determined within 14 days prior to registration, defined as:
  • Serum lactic acid dehydrogenase (LDH) </= 1.5 x ULN.
  • Alkaline phosphatase (ALP) </= 2 x ULN.
  • No weight loss >/= 10% in the proceeding 4 weeks.
  • CT scan of the brain with contrast or MRI of the brain within 28 days of registration showing no evidence of brain metastases.
  • Females of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to registration. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential.
  • Females of childbearing potential and males who have not undergone surgical sterilization must agree to practice a form of effective contraception prior to entry into the study and for 12 months following the last dose of study drug. The definition of effective contraception will be based on the judgment of the investigator.

Exclusion Criteria:

  • Melanoma of cutaneous, mucosal or conjunctival origin.
  • History of brain or leptomeningeal metastases.
  • Received any prior CTLA4 inhibiting agent (eg MDX-010, ipilimumab) or other immunotherapy.
  • History of chronic inflammatory or autoimmune disease
  • History of uveitis or melanoma-associated retinopathy.
  • History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any origin.
  • History of hepatitis due to Hepatitis B virus or Hepatitis C virus
  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: NCT01034787

Locations
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
AHS Cancer Control Alberta
  More Information

Publications:
Responsible Party: Rachel Syme, Dr. Tina Cheng, Alberta Health Services
ClinicalTrials.gov Identifier: NCT01034787     History of Changes
Other Study ID Numbers: TBCC 905001
Study First Received: December 15, 2009
Last Updated: January 18, 2012
Health Authority: Canada: Health Canada

Keywords provided by AHS Cancer Control Alberta:
CP-675,206
Immunotherapy
AntiCTLA4
Clinical Trial
Unresectable or Metastatic

Additional relevant MeSH terms:
Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on September 22, 2014