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

NCT00005074 | Completed Phase 2 DMC FDA Drug

• 4 other identifiers: I127CAN-NCIC-IND127NCI-100CDR0000067679
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Interventions

alvocidib DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Study Sites (4)

Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Cancer Care Ontario-Hamilton Regional Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Humber River Regional Hospital

Weston, Ontario, M9N 1N8, Canada

Location

Related Publications (1)

• 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.

  PMID: 12735303 RESULT

MeSH Terms

Conditions

Lymphoma; Lymphoma, Mantle-Cell

Interventions

alvocidib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Study Officials

• Joseph M. Connors, MD

  British Columbia Cancer Agency

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2000
• First Posted: January 27, 2003
• Study Start: January 24, 2000
• Primary Completion: February 20, 2002
• Study Completion: September 22, 2008
• Last Updated: April 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)