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Flavopiridol in Treating Patients With Relapsed or Refractory Lymphoma or Multiple Myeloma

This study has been terminated.
(Administratively Complete)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00112723
First received: June 2, 2005
Last updated: June 27, 2016
Last verified: June 2016
Results First Received: March 23, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adult Lymphocyte Depletion Hodgkin Lymphoma
Adult Lymphocyte Predominant Hodgkin Lymphoma
Adult Mixed Cellularity Hodgkin Lymphoma
Adult Nodular Sclerosis Hodgkin 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
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Recurrent Adult Hodgkin Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Recurrent Small Lymphocytic Lymphoma
Refractory Multiple Myeloma
Splenic Marginal Zone Lymphoma
Stage I Multiple Myeloma
Stage II Multiple Myeloma
Stage III Multiple Myeloma
Waldenström Macroglobulinemia
Intervention: Drug: alvocidib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were accrued to the study between April 2006 and September 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients with confirmed diagnosis of NHL (Non-Hodgkin's lymphoma) were accrued to one of the four cohorts defined by the World Health Organization criteria: indolent B-cell, mantle cell, intermediate-grade B-cell including transformed lymphoma and T-/NK-cell excluding primary cutaneous disease.

Reporting Groups
  Description
Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2) Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2) Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2) Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)     Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)     Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2)  
STARTED     13     19     14  
Patients Evaluable for Toxicity     11     12     12  
COMPLETED     11     12     12  
NOT COMPLETED     2     7     2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment (Alvocidib)

PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol 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.

PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.

alvocidib: Given IV


Baseline Measures
    Treatment (Alvocidib)  
Number of Participants  
[units: participants]
  46  
Age  
[units: years]
Median (Full Range)
  66  
  (34 to 84)  
Gender  
[units: patients]
 
Female     20  
Male     26  
Region of Enrollment  
[units: patients]
 
United States     45  
Canada     1  
Eastern Cooperative Oncology Group (ECOG) Performance status  
[units: patients]
 
0 (Fully active)     8  
1 (Restricted in physically strenuous activity)     34  
2 (Ambulatory capable of all selfcare)     4  
Diagnosis  
[units: patients]
 
Indolent B-cell     15  
intermediate grade B-NHL     17  
Mantle cell lymphoma     7  
T/NK cell NHL     7  



  Outcome Measures
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1.  Primary:   Disease-specific Dose-limiting Toxicity and Maximum Tolerated Dose of Flavopiridol Graded According to the CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.0 (Phase I)   [ Time Frame: 28 days ]

2.  Primary:   Maximum Tolerated Dose (MTD)   [ Time Frame: 28 days ]

3.  Primary:   Complete and Partial Response Rate (Phase II)   [ Time Frame: Up to 2 years ]

4.  Primary:   Qualitative and Quantitative Toxicities in Regard to Organ Specificity   [ Time Frame: Up to 30 days after completion of study treatment ]

5.  Primary:   Lymphoid/Plasma Cell Malignancies   [ Time Frame: Up to 2 years ]

6.  Secondary:   Pharmacokinetics (Area Under the Curve; AUC) of Flavopiridol   [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 22 of Cycle 1 ]

7.  Secondary:   Number of Patients Reporting Acute Infusion Toxicity (e.g., Fever, Hypotension, Tumor Pain, and Dyspnea)   [ Time Frame: Up to 30 days after completion of study treatment ]

8.  Secondary:   Induced Response in Patients Independent of p53 Mutational Status   [ Time Frame: Up to 2 years ]

9.  Secondary:   Pharmacodynamic Effects of Flavopiridol on Normal Peripheral Blood Mononuclear Cells (PBMCs).   [ Time Frame: Day 1 ]

10.  Secondary:   Pharmacokinetics (Cmax) of Flavopiridol   [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 22 of Cycle 1 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jeffrey Jones, MD
Organization: The Ohio State University Comprehensive Cancer Center
phone: 614-293-3507
e-mail: Jeffrey.Jones@osumc.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00112723     History of Changes
Other Study ID Numbers: NCI-2011-01346
NCI-2011-01346 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
OSU-04100
CDR0000429577
OSU-2005C0006
NCI-7002
OSU 04100 ( Other Identifier: Ohio State University Medical Center )
7002 ( Other Identifier: CTEP )
U01CA076576 ( US NIH Grant/Contract Award Number )
N01CM00070 ( US NIH Grant/Contract Award Number )
P30CA016058 ( US NIH Grant/Contract Award Number )
Study First Received: June 2, 2005
Results First Received: March 23, 2015
Last Updated: June 27, 2016
Health Authority: United States: Food and Drug Administration