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Sponsors and Collaborators: |
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00103272 |
RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving 17-N-allylamino-17-demethoxygeldanamycin together with bortezomib may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin and bortezomib in treating patients with relapsed or refractory hematologic cancer.
Condition | Intervention | Phase |
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Leukemia Lymphoma Small Intestine Cancer |
Drug: bortezomib Drug: tanespimycin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of PS-341 (Velcade™, Bortezomib) in Combination With 17-N-Allylamino-17-Demethoxygeldanamycin (17-AAG) in Patients With Relapsed or Refractory Hematologic Malignancies |
Estimated Enrollment: | 74 |
Study Start Date: | May 2005 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study. Patients are stratified according to diagnosis (acute myeloid leukemia [AML] or acute lymphoblastic leukemia vs chronic lymphoctyic leukemia or non-Hodgkin's lymphoma [NHL]).
Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1-6 hours on days 1, 4, 8, and 11 and bortezomib IV over 3-5 seconds on days 4, 8, and 11 of course 1 and on days 1, 4, 8, and 11 of all subsequent courses. Treatment repeats every 21 days for 3-12 courses provided patient is receiving clinical benefit. Patients achieving objective response may discontinue therapy to undergo stem cell transplantation.
Cohorts of 3-6 patients with receive escalating doses of 17-AAG and bortezomib 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. After the MTD is determined, an additional 20 patients (10 per stratum with AML or follicular NHL) are enrolled and receive 17-AAG and bortezomib as above at the MTD.
PROJECTED ACCRUAL: A total of 56-74 patients (36-54 [18-27 per stratum] who undergo dose escalation and 20 [10 per stratum] treated at the maximum tolerated dose) will be accrued for this study within 1-2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed diagnosis of 1 of the following hematologic malignancies:
Acute myeloid leukemia or acute lymphoblastic leukemia
Non-Hodgkin's lymphoma (NHL), including 1 of the following subtypes:
Patients with NHL or CLL must meet the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
No ongoing pulmonary symptoms ≥ grade 2 including any of the following:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | |
Columbus, Ohio, United States, 43210-1240 |
Study Chair: | Kristie A. Blum, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Study ID Numbers: | CDR0000409584, OSU-2004C0084, NCI-6520, OSU-0448 |
Study First Received: | February 7, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00103272 History of Changes |
Health Authority: | United States: Federal Government |
adult acute myeloid leukemia with 11q23 (MLL) abnormalities recurrent adult acute lymphoblastic leukemia refractory chronic lymphocytic leukemia adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) recurrent adult acute myeloid leukemia recurrent small lymphocytic lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse large cell lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma anaplastic large cell lymphoma |
angioimmunoblastic T-cell lymphoma nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue recurrent adult T-cell leukemia/lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma Waldenstrom macroglobulinemia small intestine lymphoma recurrent mycosis fungoides/Sezary syndrome adult acute megakaryoblastic leukemia (M7) adult acute minimally differentiated myeloid leukemia (M0) adult acute monoblastic leukemia (M5a) adult acute monocytic leukemia (M5b) adult acute myeloblastic leukemia with maturation (M2) adult acute myeloblastic leukemia without maturation (M1) |
Lymphoma, Mantle-Cell Mantle Cell Lymphoma Ileal Diseases Follicular Lymphoma Duodenal Neoplasms Mycoses Acute Erythroblastic Leukemia Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Anaplastic Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Digestive System Neoplasms |
Leukemia, Myeloid Protease Inhibitors Waldenstrom Macroglobulinemia Leukemia, Erythroblastic, Acute B-cell Lymphomas Leukemia, T-Cell Gastrointestinal Neoplasms Lymphoma, Non-Hodgkin Di Guglielmo's Syndrome Lymphoma, T-Cell, Cutaneous Leukemia, Monocytic, Acute Leukemia, Lymphoid Hematologic Neoplasms Gastrointestinal Diseases Acute Myelomonocytic Leukemia |
Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Ileal Diseases Duodenal Neoplasms Leukemia Neoplasms by Site Ileal Neoplasms Jejunal Diseases Therapeutic Uses Lymphoma Duodenal Diseases Jejunal Neoplasms Immunoproliferative Disorders |
Neoplasms by Histologic Type Digestive System Neoplasms Immune System Diseases Bortezomib Enzyme Inhibitors Intestinal Diseases Intestinal Neoplasms Pharmacologic Actions Protease Inhibitors Lymphatic Diseases Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Lymphoproliferative Disorders |