Bortezomib and Flavopiridol in Treating Patients With Recurr...

http://clinicaltrials.gov/ct2/show/NCT00082784?term=avopi...

Bortezomib and Flavopiridol in Treating Patients With Recurr...

http://clinicaltrials.gov/ct2/show/NCT00082784?term=avopi...

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Further study details as provided by Virginia Commonwealth University: Primary Outcome Measures: Dene recommended phase II doses for the combination bortezomib and alvocidib in the treatment of recurrent or refractory indolent B cell neoplasms. [ Time Frame: 7 yrs ] [ Designated as safety issue: Yes ] Estimated Enrollment: Study Start Date: Estimated Study Completion Date: Estimated Primary Completion Date: 60 March 2004 December 2011 December 2011 (Final data collection date for primary outcome measure)

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Bortezomib and Flavopiridol in Treating Patients With Recurrent or Refractory Indolent B-Cell Neoplasms
This study is currently recruiting participants.
Veried November 2011 by Virginia Commonwealth University First Received on May 14, 2004. Last Updated on November 15, 2011 History of Changes Sponsor: Collaborator: Information provided by (Responsible Party): ClinicalTrials.gov Identier:

Arms Experimental: alvocidib + bortezomib

Assigned Interventions Drug: alvocidib + bortezomib Alvocidib via 1 hr infusion; bortezomib via iv push over 3-5 seconds Other Names: alvocidib/avopiridol/NSC 649890 bortezomib/Velcade/PS-341/NSC 681239

Virginia Commonwealth University National Cancer Institute (NCI) Virginia Commonwealth University NCT00082784
Detailed Description: OBJECTIVES: Primary Determine the recommended phase II dose of bortezomib and avopiridol in patients with recurrent or refractory indolent B-cell neoplasms. Secondary Determine the toxic effects and maximum tolerated dose of this regimen in these patients. Determine disease-related effects of this regimen in these patients. Determine the pharmacodynamics of this regimen in patients with myeloma. 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 avopiridol 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 avopiridol until the maximum tolerated dose (MTD) is determined. The MTD is dened 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 2 years.

Purpose
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as avopiridol, work in different ways to stop cancer cells from dividing so they stop growing or die. Bortezomib may increase the effectiveness of avopiridol by making cancer cells more sensitive to the drug. Giving bortezomib together with avopiridol may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib and avopiridol in treating patients with recurrent or refractory indolent B-cell neoplasms. Condition Lymphoma Multiple Myeloma Plasma Cell Neoplasm Intervention Drug: alvocidib + bortezomib Phase Phase I

Study Type: Interventional Study Design: Allocation: Non-Randomized Endpoint Classication: Safety Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment Ofcial 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

Eligibility
Ages Eligible for Study: Genders Eligible for Study: Accepts Healthy Volunteers: 18 Years and older Both No

Criteria DISEASE CHARACTERISTICS: Diagnosis of one of the following: Follicle center lymphoma, follicular or diffuse Mantle cell lymphoma Marginal zone B-cell lymphoma, splenic, nodal, or extranodal Lymphoplasmacytoid lymphoma/immunocytoma Plasma cell myeloma Plasmacytoma Plasma cell leukemia Waldenstrom's macroglobulinemia Recurrent or refractory disease after at least 1 prior systemic treatment

Resource links provided by NLM: Genetics Home Reference related topics: aceruloplasminemia hemophilia MedlinePlus related topics: Cancer Lymphoma Multiple Myeloma Drug Information available for: Alvocidib Flavopiridol Bortezomib U.S. FDA Resources

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Bortezomib and Flavopiridol in Treating Patients With Recurr...

http://clinicaltrials.gov/ct2/show/NCT00082784?term=avopi...

Bortezomib and Flavopiridol in Treating Patients With Recurr...

http://clinicaltrials.gov/ct2/show/NCT00082784?term=avopi...

No prior CNS malignancy PATIENT CHARACTERISTICS: Age 18 and over Performance status 0-1 Life expectancy Not specied Hematopoietic Hemoglobin 8 g/dL Platelet count 100,000/mm^3 Absolute neutrophil count 1.5 x 10^9/L Hepatic Bilirubin 1.5 times upper limit of normal (ULN) AST/ALT 3 times ULN Renal Calculated creatinine clearance 50 mL/min Other No prior allergic reaction to compounds of similar chemical or biological composition to and presumably able to tolerated bortezomib, avopiridol, allopurinol, sodium polystyrene sulfonate, or dexamethasone No neuropathy grade 2 No other condition that would preclude study participation Not pregnant or nursing Fertile patients must use effective contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy Prior autologous stem cell transplantation allowed No prior allogeneic stem cell transplantation Chemotherapy Not specied Endocrine therapy Not specied Radiotherapy Not specied Surgery Not specied Other No other concurrent anticancer agents No other concurrent investigational agents United States, Virginia Virginia Commonwealth University Massey Cancer Center Richmond, Virginia, United States, 23298-0037 Contact: Mary Beth Tombes, RN, RNCS 804-628-1357 Principal Investigator: E. Brent Perkins, MD, PhD Sponsors and Collaborators Virginia Commonwealth University National Cancer Institute (NCI) Investigators Study Chair: Steven Grant, MD Massey Cancer Center Recruiting mtombes@vcu.edu

More Information
Additional Information: Clinical trial summary from the National Cancer Institute's PDQ database No publications provided Responsible Party: ClinicalTrials.gov Identier: Other Study ID Numbers: Study First Received: Last Updated: Health Authority: Virginia Commonwealth University NCT00082784 History of Changes NCI-6413, P30CA16059, MCV-MCC-6413, NCI-6413, R21CA110953, MCC-13643 May 14, 2004 November 15, 2011 United States: Food and Drug Administration

Keywords provided by Virginia Commonwealth University: recurrent grade 1 follicular lymphoma refractory multiple myeloma recurrent grade 2 follicular lymphoma recurrent marginal zone lymphoma recurrent grade 3 follicular lymphoma extranodal marginal zone B-cell lymphoma of recurrent adult diffuse small cleaved cell mucosa-associated lymphoid tissue lymphoma nodal marginal zone B-cell lymphoma recurrent adult diffuse mixed cell lymphoma splenic marginal zone lymphoma recurrent adult diffuse large cell lymphoma stage I multiple myeloma Waldenstrom macroglobulinemia stage II multiple myeloma recurrent mantle cell lymphoma stage III multiple myeloma Additional relevant MeSH terms: Flavopiridol Neoplasms Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Lymphoma, B-Cell Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoma, Non-Hodgkin Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Growth Inhibitors Growth Substances Physiological Effects of Drugs Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identier: NCT00082784 Locations United States, Florida H. Lee Moftt Cancer Center and Research Institute at University of South Florida Recruiting Tampa, Florida, United States, 33612-9497 Contact: Daniel Sullivan, MD 813-979-3878 dan.sullivan@moftt.org Contact: Anne Dellaportas, RN, BSN 813-745-4616 anne.dellaportas@moftt.org

ClinicalTrials.gov processed this record on February 06, 2012

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