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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00678223 |
RATIONALE: Monoclonal antibodies, such as IMC-A12, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving monoclonal antibody IMC-A12 together with temsirolimus may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of monoclonal antibody IMC-A12 and temsirolimus in treating patients with locally advanced or metastatic cancer.
Condition | Intervention | Phase |
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Chronic Myeloproliferative Disorders Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Precancerous/Nonmalignant Condition Unspecified Adult Solid Tumor, Protocol Specific |
Biological: cixutumumab Drug: temsirolimus |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase I Study of IMC-A12 (NSC# 742460) in Combination With Temsirolimus CCI-779 (NSC# 683864) in Patients With Advanced Cancers |
Estimated Enrollment: | 63 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group A (MTD expansion cohort): Experimental
Patients receive temsirolimus IV over 30 minutes on days 15 and 22 for course 1 and on days 1, 8, 15, and 22 for all subsequent courses. Patients also receive 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.
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Biological: cixutumumab
Given IV
Drug: temsirolimus
Given IV
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Group B (MTD expansion cohort): Experimental
Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 60 minutes on days 15 and 22 for course 1 and on days 1, 8, 15, and 22 for all subsequent courses. Patients also receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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Biological: cixutumumab
Given IV
Drug: temsirolimus
Given IV
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Group C (MTD expansion cohort): Experimental
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.
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Biological: cixutumumab
Given IV
Drug: temsirolimus
Given IV
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
MTD expansion cohort: Patients are assigned to 1 of 3 treatment groups.
After completion of study treatment, patients are followed within 30 days.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of locally advanced or metastatic cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
At least 4 weeks since prior chemotherapy, other investigational therapy, biological therapy, targeted agents, or radiotherapy
At least 5 half-lives since prior and no concurrent drugs that are strong P450 CYP3A4 inhibitors or inducers
United States, Texas | |
M. D. Anderson Cancer Center at University of Texas | Recruiting |
Houston, Texas, United States, 77030-4009 | |
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 |
Study Chair: | Aung Naing, MD | M.D. Anderson Cancer Center |
Investigator: | Patricia M. LoRusso, DO | Barbara Ann Karmanos Cancer Institute |
Study ID Numbers: | CDR0000595388, MDA-2007-0595 |
Study First Received: | May 9, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00678223 History of Changes |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific accelerated phase chronic myelogenous leukemia acute undifferentiated leukemia adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) atypical chronic myeloid leukemia blastic phase chronic myelogenous leukemia chronic myelomonocytic leukemia chronic phase chronic myelogenous leukemia mast cell leukemia meningeal chronic myelogenous leukemia progressive hairy cell leukemia, initial treatment |
prolymphocytic leukemia recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia recurrent adult T-cell leukemia/lymphoma refractory chronic lymphocytic leukemia refractory hairy cell leukemia relapsing chronic myelogenous leukemia secondary acute myeloid leukemia stage III adult T-cell leukemia/lymphoma stage III chronic lymphocytic leukemia stage IV adult T-cell leukemia/lymphoma stage IV chronic lymphocytic leukemia T-cell large granular lymphocyte leukemia untreated adult acute lymphoblastic leukemia untreated adult acute myeloid leukemia |
Polycythemia Chronic Myelomonocytic Leukemia Blast Crisis Large Granular Lymphocyte Leukemia Lymphoma, Mantle-Cell Mantle Cell Lymphoma Follicular Lymphoma Mycoses Acute Myelocytic Leukemia Preleukemia Hemorrhagic Disorders Leukemia, Prolymphocytic Acute Myeloid Leukemia, Adult Leukemia, Lymphocytic, Chronic, B-Cell Neoplasm Metastasis |
Lymphoma, Large-Cell, Anaplastic Thrombocythemia, Hemorrhagic Hodgkin Disease Myelodysplastic Myeloproliferative Disease Immunoglobulins Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Blood Coagulation Disorders Leukemia, Myelomonocytic, Chronic Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Mast-Cell Hairy Cell Leukemia Myeloproliferative Disorders |
Precancerous Conditions Blood Protein Disorders Paraproteinemias Hemostatic Disorders Leukemia Preleukemia Hemorrhagic Disorders Pathologic Processes Syndrome Cardiovascular Diseases Lymphoma Disease Neoplasms by Histologic Type Immunoproliferative Disorders |
Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Vascular Diseases Multiple Myeloma Lymphatic Diseases Neoplasms Bone Marrow Diseases Myelodysplastic-Myeloproliferative Diseases Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Neoplasms, Plasma Cell |