Flavopiridol in Treating Patients With Recurrent Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma

Lymphoma Clinical Trial

Official title:

A Phase II Trial of Flavopiridol (NSC 649890) Administered as a 72-Hour Continuous Infusion Every 2 Weeks in Patients With Previously Treated Intermediate and High Grade Non-Hodgkin's Lymphoma Including Mantle Cell Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003039
• Other study ID #: NCI-2012-02253
• Secondary ID: UCCRC-8548NCI-T9
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: February 4, 2013
• Start date: September 1997

Study information

• Verified date: April 2000
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Phase II trial to study the effectiveness of flavopiridol in treating patients with recurrent intermediate-grade or high-grade non-Hodgkin's lymphoma or mantle cell lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

Description:

OBJECTIVES:

I. Determine the objective response rate to flavopiridol by patients with previously treated intermediate and high grade non-Hodgkin's lymphoma and mantle cell lymphoma.

II. Determine the toxicity of flavopiridol administered as a continuous infusion every 2 weeks in these patients.

III. Study the pharmacokinetics of flavopiridol in these patients.

OUTLINE: This is an open label, multi-institutional study.

Patients receive treatment on an outpatient basis. Flavopiridol is administered as a continuous infusion over 72 hours every 2 weeks. Patients receive a minimum of 4 cycles of therapy unless unacceptable toxicity or disease progression occurs. Patients are followed until death.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: April 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed intermediate or high grade non-Hodgkin's lymphoma (NHL) and mantle cell lymphoma with clinical or pathological evidence of recurrent disease

• Measurable or evaluable disease

• CNS metastases not requiring intravenous steroid therapy allowed

PATIENT CHARACTERISTICS:

• Age: 18 and over

• Performance status: CALGB 0-2

• Life expectancy: At least 12 weeks

• Absolute neutrophil count at least 1500/mm3 (unless due to bone marrow involvement by lymphoma)

• Platelet count at least 100,000/mm3 (unless due to bone marrow involvement by lymphoma)

• At least 7 days since platelet transfusion

• Hemoglobin at least 9.0 g/dL

• Bilirubin no greater than 1.5 mg/dL

• Transaminases no greater than 2.5 times upper limit of normal

• Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min

• No significant uncontrolled medical or psychiatric illness

• No active serious infection

• Not pregnant or lactating

• Fertile patients must use effective contraception

• Central venous catheter required prior to study entry

PRIOR CONCURRENT THERAPY:

• No more than 1 prior chemotherapy regimen

• At least 4 weeks since prior chemotherapy and recovered from all toxic effects Prior chemotherapy must contain anthracycline if intermediate or high-grade NHL other than mantle cell

• No concurrent treatment with other chemotherapeutic or investigational antineoplastic drugs

• At least 4 weeks since prior radiation therapy and recovered (Site of only measurable disease must not be located within prior radiation therapy port)

• No concurrent radiation therapy to any lesion

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• alvocidib

Locations

Country	Name	City	State
United States	Clinical Sciences Building	Chicago	Illinois
United States	Louis A. Weiss Memorial Hospital	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Cancer Care Specialists of Central Illinois, S.C.	Decatur	Illinois
United States	Evanston Northwestern Health Care	Evanston	Illinois
United States	Fort Wayne Medical Oncology and Hematology, Inc.	Fort Wayne	Indiana
United States	Lutheran General Hospital	Park Ridge	Illinois
United States	Oncology/Hematology Associates of Central Illinois, P.C.	Peoria	Illinois
United States	Michiana Hematology/Oncology P.C.	South Bend	Indiana
United States	Central Illinois Hematology Oncology Center	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,