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| Sponsor: | Mayo Clinic |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00096005 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as 17-AAG, work in different ways to stop cancer cells from dividing so they stop growing or die. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It may also increase the effectiveness of 17-AAG by making cancer cells more sensitive to the drug. Combining 17-AAG with bortezomib may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of giving 17-AAG together with bortezomib in treating patients with advanced solid tumorsor lymphomas. (Accrual for lymphoma patients closed as of 11/27/09)
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma Unspecified Adult Solid Tumor, Protocol Specific |
Drug: bortezomib Drug: tanespimycin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Trial Of 17-Allylaminogeldanamycin (17-AAG) And PS341 In Advanced Malignancies |
| Estimated Enrollment: | 36 |
| Study Start Date: | November 2004 |
| Estimated Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1-2 hours and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. 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 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. Once the MTD is determined, at least 12 additional patients are treated as above* at the MTD.
NOTE: *Bortezomib is not administered on day 1 of course 1 only.
Patients are followed at 3 months.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
No symptomatic pulmonary disease requiring medication including any of the following:
Neurologic
No neuropathic pain of any etiology
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent warfarin
Contacts and Locations| United States, Florida | |
| Mayo Clinic - Jacksonville | Recruiting |
| Jacksonville, Florida, United States, 32224 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| Study Chair: | Charles Erlichman, MD | Mayo Clinic |
More Information
| Study ID Numbers: | CDR0000391837, MAYO-MC0214, NCI-6121 |
| Study First Received: | November 9, 2004 |
| Last Updated: | January 19, 2010 |
| ClinicalTrials.gov Identifier: | NCT00096005 History of Changes |
| Health Authority: | Unspecified |
|
unspecified adult solid tumor, protocol specific recurrent adult T-cell leukemia/lymphoma stage III adult T-cell leukemia/lymphoma stage IV adult T-cell leukemia/lymphoma adult grade III lymphomatoid granulomatosis AIDS-related peripheral/systemic lymphoma anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell 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 stage III adult lymphoblastic lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage III mycosis fungoides/Sezary syndrome stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage III mantle cell lymphoma stage III marginal zone lymphoma stage III small lymphocytic lymphoma stage IV adult Burkitt lymphoma stage IV adult diffuse large cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult Hodgkin lymphoma |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Bortezomib Enzyme Inhibitors Pharmacologic Actions |
Protease Inhibitors Lymphatic Diseases Neoplasms Therapeutic Uses Lymphoma, Large-Cell, Immunoblastic Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |