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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00058 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000360816 | |||
| MCC 6413 | |||
| MCC-6413 | Other Identifier | Moffitt Cancer Center | |
| 6413 | Other Identifier | CTEP | |
| R21CA110953 | U.S. NIH Grant/Contract | View source | |
| P30CA076292 | U.S. NIH Grant/Contract | View source | |
| N01CM00100 | U.S. NIH Grant/Contract | View source |
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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. 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.
PRIMARY OBJECTIVES:
I. To determine the recommended phase II dose of bortezomib and flavopiridol in patients with recurrent or refractory indolent B-cell neoplasms.
SECONDARY OBJECTIVES:
I. To determine the toxic effects and maximum tolerated dose of this regimen in these patients.
II. To determine disease-related effects of this regimen in these patients. III. To determine the pharmacodynamics of this regimen in patients with myeloma.
IV. To determine the pharmacokinetics of this regimen in these patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug | Given IV |
| |
| Alvocidib Hydrochloride |
| Measure | Description | Time Frame |
|---|---|---|
| Recommended phase II dose | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose, assessed according to NCI CTCAE v4.0 | 21 days | |
| Response | Up to 8 years | |
| Response duration |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Grant | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States | ||
| University of Pittsburgh Cancer Institute |
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| Drug |
Given IV |
|
|
| Pharmacological Study | Other | Correlative studies |
|
|
| Up to 8 years |
| Time to progression | Up to 8 years |
| Survival | Up to 8 years |
| Pittsburgh |
| Pennsylvania |
| 15232 |
| United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15232 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | 23298 | United States |
| ID | Term |
|---|---|
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D009101 | Multiple Myeloma |
| D008258 | Waldenstrom Macroglobulinemia |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| C077990 | alvocidib |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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