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Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
alvocidib
Sponsored by
NCIC Clinical Trials Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring stage I mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, recurrent mantle cell lymphoma, stage II mantle cell lymphoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed mantle cell lymphoma (at initial diagnosis) nonrefractory to prior therapy or with no prior therapy No documented disease progression while receiving prior chemotherapy CD20 and CD5 positive Presence of clinically and/or radiologically documented disease At least 1 site of disease must be bidimensionally measurable Bone lesions not considered bidimensionally measurable Minimum indicator lesions must be: Lymph nodes at least 1.5 cm x 1.5 cm by physical exam or spiral CT scan OR Other nonnodal lesions at least 1 cm x 1 cm by MRI, CT scan, or physical exam No known CNS involvement by lymphoma PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit or normal (ULN) AST no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 60 mL/min Cardiovascular: No clinically significant cardiac symptomatology If history of cardiac disease, cardiac ejection fraction greater than 50% Pulmonary: No clinically significant pulmonary symptomatology If history of symptomatic pulmonary disease: FEV1, FVC, and TLC greater than 60% predicted DLCO greater than 50% predicted Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Must be accessible for treatment and follow-up (i.e., no geographical limitations) No uncontrolled bacterial, fungal, or viral infection No other serious concurrent disease PRIOR CONCURRENT THERAPY: Biologic therapy: No prior radioactive monoclonal antibody therapy Prior rituximab allowed Chemotherapy: See Disease Characteristics No more than 2 prior chemotherapy regimens allowed Same chemotherapy combination given for first line and second line therapy considered 2 regimens At least 6 weeks since prior chemotherapy No prior high-dose chemotherapy and stem cell transplantation No other concurrent cytotoxic chemotherapy Endocrine therapy: No concurrent corticosteroids Radiotherapy: No prior radiotherapy to greater than 25% of functioning bone marrow At least 4 weeks since prior radiotherapy (except low-dose, non-myelosuppressive radiotherapy) and recovered No concurrent radiotherapy to sole site of measurable disease Surgery: At least 2 weeks since prior major surgery Other: No other concurrent investigational anticancer agents

Sites / Locations

  • Nova Scotia Cancer Centre
  • Cancer Care Ontario-Hamilton Regional Cancer Centre
  • Toronto General Hospital
  • Humber River Regional Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 6, 2000
Last Updated
April 7, 2020
Sponsor
NCIC Clinical Trials Group
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1. Study Identification

Unique Protocol Identification Number
NCT00005074
Brief Title
Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma
Official Title
A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Untreated or Relapsed Mantle Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 24, 2000 (Actual)
Primary Completion Date
February 20, 2002 (Actual)
Study Completion Date
September 22, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have previously untreated or relapsed mantle cell lymphoma.
Detailed Description
OBJECTIVES: Assess the efficacy of flavopiridol in terms of response rate in patients with previously untreated or relapsed mantle cell lymphoma. Assess the toxicity of this regimen in this patient population. Determine the time to progression and, if responses are observed, response duration in these patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive flavopiridol IV over 1 hour daily for 3 days. Treatment continues every 3 weeks in the absence of unacceptable toxicity or disease progression. Patients with a complete response (CR) receive 2 additional courses after documented CR. Patients with a partial response receive 2 additional courses after documented maximal tumor shrinkage. Patients with stable disease receive a maximum of 4 courses. Patients are followed at 4 weeks and then every 3 months until relapse or death. PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 18-24 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
stage I mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, recurrent mantle cell lymphoma, stage II mantle cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
alvocidib

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed mantle cell lymphoma (at initial diagnosis) nonrefractory to prior therapy or with no prior therapy No documented disease progression while receiving prior chemotherapy CD20 and CD5 positive Presence of clinically and/or radiologically documented disease At least 1 site of disease must be bidimensionally measurable Bone lesions not considered bidimensionally measurable Minimum indicator lesions must be: Lymph nodes at least 1.5 cm x 1.5 cm by physical exam or spiral CT scan OR Other nonnodal lesions at least 1 cm x 1 cm by MRI, CT scan, or physical exam No known CNS involvement by lymphoma PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit or normal (ULN) AST no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 60 mL/min Cardiovascular: No clinically significant cardiac symptomatology If history of cardiac disease, cardiac ejection fraction greater than 50% Pulmonary: No clinically significant pulmonary symptomatology If history of symptomatic pulmonary disease: FEV1, FVC, and TLC greater than 60% predicted DLCO greater than 50% predicted Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Must be accessible for treatment and follow-up (i.e., no geographical limitations) No uncontrolled bacterial, fungal, or viral infection No other serious concurrent disease PRIOR CONCURRENT THERAPY: Biologic therapy: No prior radioactive monoclonal antibody therapy Prior rituximab allowed Chemotherapy: See Disease Characteristics No more than 2 prior chemotherapy regimens allowed Same chemotherapy combination given for first line and second line therapy considered 2 regimens At least 6 weeks since prior chemotherapy No prior high-dose chemotherapy and stem cell transplantation No other concurrent cytotoxic chemotherapy Endocrine therapy: No concurrent corticosteroids Radiotherapy: No prior radiotherapy to greater than 25% of functioning bone marrow At least 4 weeks since prior radiotherapy (except low-dose, non-myelosuppressive radiotherapy) and recovered No concurrent radiotherapy to sole site of measurable disease Surgery: At least 2 weeks since prior major surgery Other: No other concurrent investigational anticancer agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph M. Connors, MD
Organizational Affiliation
British Columbia Cancer Agency
Official's Role
Study Chair
Facility Information:
Facility Name
Nova Scotia Cancer Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Cancer Care Ontario-Hamilton Regional Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Humber River Regional Hospital
City
Weston
State/Province
Ontario
ZIP/Postal Code
M9N 1N8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12735303
Citation
Kouroukis CT, Belch A, Crump M, Eisenhauer E, Gascoyne RD, Meyer R, Lohmann R, Lopez P, Powers J, Turner R, Connors JM; National Cancer Institute of Canada Clinical Trials Group. Flavopiridol in untreated or relapsed mantle-cell lymphoma: results of a phase II study of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2003 May 1;21(9):1740-5. doi: 10.1200/JCO.2003.09.057.
Results Reference
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Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma

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