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The High-Dose Aldesleukin (IL-2) "SELECT" Trial: A Prospective Tissue Collection Protocol to Investigate Predictive Models of Response to High-Dose IL-2 Treatments in Patients With Advance Melanoma


N/A
18 Years
N/A
Open (Enrolling)
Both
Malignant Melanoma

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Trial Information

The High-Dose Aldesleukin (IL-2) "SELECT" Trial: A Prospective Tissue Collection Protocol to Investigate Predictive Models of Response to High-Dose IL-2 Treatments in Patients With Advance Melanoma


Original tumor slides will be collected to identify tumor markers that may predict responses
to treatment. Blood samples will be obtained prior to treatment with IL-2.


Inclusion Criteria:



- Malignant melanoma that is metastatic or unresectable

- Eligible to receive high-dose IL-2

- Tissue block available with adequate tumor to perform RNA extraction and DASL
analysis

Exclusion Criteria:

- Prior immunotherapy for unresectable or metastatic disease

- Untreated brain metastases, leptomeningeal disease, or seizure disorder

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

To determine if DASL subclassification can identify a group of patients with advanced melanoma who are significantly more likely to respond to high dose IL-2 based on therapy than the historical 16% response rate in an unselected patient population

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

David McDermott, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Institutional Review Board

Study ID:

09-333

NCT ID:

NCT01288963

Start Date:

February 2010

Completion Date:

Related Keywords:

  • Malignant Melanoma
  • melanoma
  • IL-2
  • Aldesleukin
  • Melanoma

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215