In Vivo Effects of GC1008, A Human Anti Transforming Growth Factor-beta (TGF¿) Monoclonal Antibody, on TGF-beta Receptor/Smad Signaling In Human Peripheral Blood Mononuclear Cells
| City: |
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New Brunswick |
| State: |
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New Jersey |
| Zip Code: |
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08903 |
| Conditions: |
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Kidney Cancer - Melanoma (Skin) |
| Purpose: |
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RATIONALE: Studying samples of blood in the laboratory from patients receiving monoclonal
antibody GC1008 may help doctors learn more about the effects of GC1008 on cells. It may
also help doctors understand how well patients respond to treatment.
PURPOSE: This research study is looking at the effects of monoclonal antibody GC1008 in
blood samples from patients with unresectable locally advanced or metastatic kidney cancer
or malignant melanoma treated on clinical trial NCI-06-C-0200.
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| Study Summary: |
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OBJECTIVES:
- To determine whether treatment with human anti-TGF-beta monoclonal antibody GC1008
results in a detectable decrease in phospho-Smad2 levels in freshly collected blood
samples from patients with unresectable locally advanced or metastatic renal cell
carcinoma or malignant melanoma treated on clinical trial NCI-06-C-0200.
- To determine whether the decrease in phospho-Smad2 levels is dose-dependent.
OUTLINE: This is a multicenter study.
Blood samples are collected from patients at baseline and on days 7, 56, and 63 for
laboratory biomarker analysis. Levels of phospho-Smad2 and total Smad2 are measured by a
bioassay and western blotting.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically confirmed renal cell carcinoma or malignant melanoma meeting 1 of the
following criteria:
- Unresectable locally advanced disease
- Metastatic disease
- Enrolled on clinical trial NCI-06-C-0200
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
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| NCT ID: |
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NCT00899444 |
| Primary Contact: |
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Principal Investigator
Michael Reiss, MD
Cancer Institute of New Jersey
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| Backup Contact: |
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N/A |
| Location Contact: |
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New Brunswick, New Jersey 08903
United States
Clinical Trials Office - Cancer Institute of New Jersey
Phone: 732-235-8675
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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