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| Sponsors and Collaborators: |
Cancer Institute of New Jersey National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00899444 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Kidney Cancer Melanoma (Skin) |
Genetic: western blotting Other: laboratory biomarker analysis |
| Study Type: | Observational |
| Official Title: | 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 |
| Estimated Enrollment: | 36 |
| Study Start Date: | December 2006 |
| Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed renal cell carcinoma or malignant melanoma meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, New Jersey | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | Recruiting |
| New Brunswick, New Jersey, United States, 08903 | |
| Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675 | |
| Principal Investigator: | Michael Reiss, MD | Cancer Institute of New Jersey |
More Information
| Study ID Numbers: | CDR0000592895, CINJ-000616, CINJ-IRB-0220060310 |
| Study First Received: | May 9, 2009 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00899444 History of Changes |
| Health Authority: | Unspecified |
|
recurrent renal cell cancer stage III renal cell cancer stage IV renal cell cancer |
recurrent melanoma stage III melanoma stage IV melanoma |
|
Urinary Tract Neoplasm Immunologic Factors Urogenital Neoplasms Urologic Neoplasms Melanoma Antibodies, Monoclonal Renal Cancer Urologic Diseases Kidney Neoplasms Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Mitogens |
Kidney Diseases Immunoglobulins Kidney Cancer Recurrence Neuroendocrine Tumors Carcinoma Neuroectodermal Tumors Antibodies Carcinoma, Renal Cell Nevus Adenocarcinoma Neoplasms, Glandular and Epithelial |
|
Neoplasms by Histologic Type Immunologic Factors Physiological Effects of Drugs Neoplasms, Nerve Tissue Urogenital Neoplasms Urologic Neoplasms Pharmacologic Actions Neuroendocrine Tumors Melanoma Carcinoma Antibodies, Monoclonal |
Neuroectodermal Tumors Neoplasms Neoplasms by Site Urologic Diseases Kidney Neoplasms Neoplasms, Germ Cell and Embryonal Carcinoma, Renal Cell Nevi and Melanomas Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |
