|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Massey Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00082784 |
Purpose
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as flavopiridol, work in different ways to stop cancer cells from dividing so they stop growing or die. Bortezomib may increase the effectiveness of flavopiridol by making cancer cells more sensitive to the drug. Giving bortezomib together with flavopiridol may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib and flavopiridol in treating patients with recurrent or refractory indolent B-cell neoplasms.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma Multiple Myeloma and Plasma Cell Neoplasm |
Drug: alvocidib Drug: bortezomib |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Trial of Bortezomib (PS-341; NSC 681239) and Alvocidib (Flavopiridol NSC 649890) in Patients With Recurrent or Refractory Indolent B-Cell Neoplasms |
| Estimated Enrollment: | 48 |
| Study Start Date: | March 2004 |
| Estimated Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive bortezomib IV over 3-5 seconds followed by flavopiridol IV over 1 hour 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 bortezomib and flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 2½ years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of one of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Recruiting |
| Tampa, Florida, United States, 33612-9497 | |
| Contact: Clinical Trials Office - H. Lee Moffitt Cancer Center and Rese 800-456-7121 canceranswers@moffitt.org | |
| United States, South Carolina | |
| Hollings Cancer Center at Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Clinical Trials Office - Hollings Cancer Center at Medical Uni 843-792-9321 | |
| United States, Virginia | |
| Virginia Commonwealth University Massey Cancer Center | Recruiting |
| Richmond, Virginia, United States, 23298-0037 | |
| Contact: Clinical Trials Office -Virginia Commonwealth University Masse 804-628-1939 | |
| Study Chair: | Steven Grant, MD | Massey Cancer Center |
More Information
| Study ID Numbers: | CDR0000360816, MCV-MCC-6413, NCI-6413 |
| Study First Received: | May 14, 2004 |
| Last Updated: | January 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00082784 |
| Health Authority: | Unspecified |
|
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma Waldenstrom macroglobulinemia recurrent mantle cell lymphoma |
refractory multiple myeloma recurrent marginal zone lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
|
Blood Protein Disorders Lymphoma, Mantle-Cell Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Lymphoma, B-Cell, Marginal Zone Paraproteinemias Hemostatic Disorders Lymphoma, large-cell Lymphoma, B-Cell Hemorrhagic Disorders Multiple myeloma Waldenstrom macroglobulinemia Lymphoma Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders |
Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Mantle cell lymphoma Recurrence Multiple Myeloma Flavopiridol Lymphatic Diseases Waldenstrom Macroglobulinemia B-cell lymphomas Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Follicular lymphoma Neoplasms, Plasma Cell |
|
Neoplasms by Histologic Type Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors |
Protein Kinase Inhibitors Pharmacologic Actions Protease Inhibitors Neoplasms Therapeutic Uses Cardiovascular Diseases Growth Inhibitors |
