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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00699491 |
RATIONALE: Monoclonal antibodies, such as IMC-A12, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread.
Others find tumor cells and help kill them or carry tumor-killing substances to them. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving IMC-A12 together with temsirolimus may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of IMC-A12 when given together with temsirolimus and to see how well they work in treating patients with locally recurrent or metastatic breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Biological: cixutumumab Drug: temsirolimus Genetic: fluorescence in situ hybridization Genetic: gene expression analysis Genetic: mutation analysis Genetic: proteomic profiling Genetic: reverse transcriptase-polymerase chain reaction Genetic: western blotting Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: pharmacological study |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase I/II Trial of IMC-A12 in Combination With Temsirolimus in Patients With Metastatic Breast Cancer |
Estimated Enrollment: | 68 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive temsirolimus IV over 30 minutes and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 60 minutes on days 1, 8, 15, and 22.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Peripheral blood samples are collected periodically for circulating markers and mononuclear cells. Samples are analyzed for pharmacodynamic assessments via western blot and proteomic studies.
If pre-existing tumor tissue is available, tissue is examined by immunohistochemical staining for markers (e.g., pIRS-1, pIGF-IR, pMAPK, pAKT [S473], pS6, PTEN, Stathmin). Fluorescence in situ hybridization is used to assess IGF-IR amplification. Gene resequencing is performed to identify mutations of PIK3CA (exons 9 and 20), AKT1, and other genes. Genes IGF-1, IGF-II, IGFBP-1, IGFBP-3, and others are analyzed by reverse transcriptase-polymerase chain reaction.
After completion of study treatment, patients are followed periodically for up to 2 (phase I) or 5 (phase II) years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of breast cancer
No uncontrolled brain metastases
PATIENT CHARACTERISTICS:
No poorly controlled diabetes mellitus (phase II only)
No uncontrolled intercurrent illness including, but not limited to:
PRIOR CONCURRENT THERAPY:
United States, Illinois | |
University of Chicago Cancer Research Center | Recruiting |
Chicago, Illinois, United States, 60637-1470 | |
Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
United States, Missouri | |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
Contact: Cynthia X. Ma, MD, PhD 314-362-8903 |
Study Chair: | Cynthia X. Ma, MD, PhD | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
Investigator: | Gini F. Fleming, MD | University of Chicago |
Responsible Party: | Mayo Clinic Cancer Center ( Charles Erlichman ) |
Study ID Numbers: | CDR0000598057, MAYO-MC0736 |
Study First Received: | June 17, 2008 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00699491 History of Changes |
Health Authority: | Unspecified |
stage IV breast cancer male breast cancer recurrent breast cancer |
Skin Diseases Breast Neoplasms, Male Breast Neoplasms |
Breast Cancer, Male Breast Diseases Recurrence |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |