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

A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Untreated or Relapsed Mantle Cell Lymphoma

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00005074
Enrollment
33
Registered
2003-01-27
Start date
2000-01-24
Completion date
2008-09-22
Last updated
2020-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DRUGalvocidib

Sponsors

NCIC Clinical Trials Group
Lead SponsorNETWORK

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion 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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026