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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00644072 |
RATIONALE: Drugs used in chemotherapy, such as SNX-5422, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of SNX-5422 in treating patients with solid tumor or lymphoma that has not responded to treatment.
Condition | Intervention | Phase |
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Leukemia Lymphoma Lymphoproliferative Disorder Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: Hsp90 inhibitor SNX-5422 mesylate Other: flow cytometry Other: high performance liquid chromatography Other: mass spectrometry Other: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of SNX-5422 Mesylate in Adults With Refractory Solid Tumor Malignancies and Lymphomas |
Estimated Enrollment: | 78 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral Hsp90 inhibitor SNX-5422 mesylate twice weekly in weeks 1-4. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients undergo blood and urine sample collection for pharmacokinetic, pharmacodynamic analysis in course 1.
Samples are evaluated using high performance liquid chromatography and tandem mass spectrometry to measure plasma and urine concentrations of Hsp90 inhibitor SNX-5422 mesylate and its metabolite, SNX-2112. Analyses of Hsp90 clients in peripheral blood mononuclear cells and the effect of Hsp90 inhibitor SNX-5422 on Hsp90 clients in tumor tissue are performed.
After completion of study therapy, patients are followed periodically.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically documented diagnosis of 1 of the following:
Lymphoid malignancy (i.e., lymphoma or chronic lymphocytic leukemia)
No symptomatic brain metastases
PATIENT CHARACTERISTICS:
No uncontrolled medical illness including, but not limited to, any of the following:
No gastrointestinal diseases that could alter the assessment of safety, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Principal Investigator: | Giuseppe Giaccone, MD, PhD | NCI - Medical Oncology Branch |
Study ID Numbers: | CDR0000590247, NCI-08-C-0091, NCI-P07318 |
Study First Received: | March 25, 2008 |
Last Updated: | July 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00644072 History of Changes |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific recurrent adult T-cell leukemia/lymphoma stage IV adult T-cell leukemia/lymphoma adult nasal type extranodal NK/T-cell lymphoma anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma splenic marginal zone lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma stage IV adult Hodgkin lymphoma stage IV mycosis fungoides/Sezary syndrome recurrent adult Hodgkin lymphoma recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma |
recurrent adult diffuse small cleaved cell lymphoma recurrent adult grade III lymphomatoid granulomatosis recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent mycosis fungoides/Sezary syndrome recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma Burkitt lymphoma intraocular lymphoma primary central nervous system lymphoma |
Lymphoma, Mantle-Cell Mantle Cell Lymphoma Ileal Diseases Follicular Lymphoma Duodenal Neoplasms Mycoses Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Anaplastic Hodgkin Disease Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Digestive System Neoplasms Waldenstrom Macroglobulinemia B-cell Lymphomas Leukemia, T-Cell |
Gastrointestinal Neoplasms Lymphoma, Non-Hodgkin Lymphoma, T-Cell, Cutaneous Leukemia, Lymphoid Gastrointestinal Diseases Lymphoma, Follicular Central Nervous System Lymphoma, Primary Lymphoma, B-Cell, Marginal Zone Sezary Syndrome Mycosis Fungoides Lymphoblastic Lymphoma Lymphoma, Large-cell, Immunoblastic Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse Leukemia |
Jejunal Neoplasms Digestive System Neoplasms Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Gastrointestinal Diseases Intestinal Diseases Ileal Diseases Intestinal Neoplasms Duodenal Neoplasms Leukemia |
Lymphatic Diseases Neoplasms Digestive System Diseases Neoplasms by Site Ileal Neoplasms Jejunal Diseases Gastrointestinal Neoplasms Lymphoproliferative Disorders Lymphoma Duodenal Diseases |