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PET Quantitative Assessments of Solid Tumor Response to Immune Checkpoint Blockade Therapy


Phase 0
18 Years
N/A
Open (Enrolling)
Both
Melanoma, Renal Cell Carcinoma (RCC), Non-small Cell Lung Cancer (NSCLC)

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Trial Information

PET Quantitative Assessments of Solid Tumor Response to Immune Checkpoint Blockade Therapy


Inclusion Criteria:



1. Age ≥18 years

2. Any subject with documented metastatic melanoma, RCC or NSCLC.

3. Subjects must be scheduled to receive therapy, or received only one dose, with an
anti-neoplastic agent that works by immune checkpoint blockade such as
ipilimumab/Yervoy (anti-CTLA-4), MDX-1106/BMS-936558 (anti-PD-1) or
MDX-1105/BMS-936559 (anti-B7-H1) mAbs.

4. Subjects must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension as >10 mm with spiral CT scan.

Exclusion Criteria:

1. Patient is unable to provide informed consent

2. Patient is pregnant

3. Patient enrollment on research protocol which includes an additional mid-therapy
investigational FDG PET/CT at approximately month from start of therapy.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Compare FDG PET-based qualitative and quantitative tumor response assessment with standard CT immune RECIST criteria

Outcome Description:

• To compare FDG PET-based qualitative and quantitative tumor response assessment with standard CT immune RECIST criteria in patients receiving immune checkpoint blockade therapy for melanoma, renal cell carcinoma (RCC), and non-small cell lung cancer (NSCLC). Patients will receive 2 standard of care treatment FDG scans, the first scan at the begining of treatment and the second scan at the end of treatment. The research scan will be done between the first and second scan.

Outcome Time Frame:

6 months after completion of standard of care treatment

Safety Issue:

Yes

Principal Investigator

Steve Y Cho, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University

Authority:

United States: Institutional Review Board

Study ID:

J1208

NCT ID:

NCT01666353

Start Date:

April 2012

Completion Date:

December 2014

Related Keywords:

  • Melanoma
  • Renal Cell Carcinoma (RCC)
  • Non-Small Cell Lung Cancer (NSCLC)
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Lung Neoplasms
  • Melanoma

Name

Location
Johns Hopkins University Baltimore, Maryland  21205