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Sponsors and Collaborators: |
University of Wisconsin, Madison National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00354185 |
RATIONALE: PDX101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin (17-AAG), work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving PXD101 together with 17-AAG may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of giving PDX101 together with 17-AAG in treating patients with metastatic or unresectable solid tumors or lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma Lymphoproliferative Disorder Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: belinostat Drug: tanespimycin Procedure: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of PXD101 in Combination With 17-AAG in Advanced Malignancies |
Estimated Enrollment: | 36 |
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a dose-escalation study.
Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 2 hours on days 1, 4, 8, and 11 and PXD101 IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of 17-AAG and PDX101 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 12 patients are treated at the MTD.
Patients undergo blood collection on days 1 and 4 of course 1 for pharmacokinetic studies.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000489088, WCCC-CO-05906, NCI-7277 |
Study First Received: | July 19, 2006 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00354185 |
Health Authority: | United States: Food and Drug Administration |
unspecified adult solid tumor, protocol specific anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue intraocular lymphoma nodal marginal zone B-cell 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 Hodgkin lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent adult T-cell leukemia/lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma |
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent mycosis fungoides/Sezary syndrome recurrent small lymphocytic lymphoma small intestine lymphoma splenic marginal zone lymphoma stage III adult Burkitt lymphoma stage III adult diffuse large cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult Hodgkin lymphoma stage III adult immunoblastic large cell lymphoma |
Sezary syndrome Hodgkin lymphoma, adult Lymphoma, Mantle-Cell Lymphoma, small cleaved-cell, diffuse Ileal Diseases Lymphoma, large-cell, immunoblastic Duodenal Neoplasms Lymphomatoid granulomatosis Mycoses Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Anaplastic Hodgkin Disease Chronic lymphocytic leukemia Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders |
Digestive System Neoplasms Leukemia, B-cell, chronic Waldenstrom Macroglobulinemia B-cell lymphomas Leukemia, T-Cell Gastrointestinal Neoplasms Anaplastic large cell lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell, Cutaneous Hodgkin's disease Gastrointestinal Diseases Cutaneous T-cell lymphoma Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Sezary Syndrome |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Immune System Diseases Jejunal Diseases |