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

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00003039

Collaborator

(none)

Enrollment

Locations

Arm

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: alvocidib	Phase 2

Detailed Description

OBJECTIVES:

Determine the objective response rate to flavopiridol by patients with previously treated intermediate and high grade non-Hodgkin's lymphoma and mantle cell lymphoma.
Determine the toxicity of flavopiridol administered as a continuous infusion every 2 weeks in these patients.
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Sep 1, 1997

Actual Primary Completion Date :

Apr 1, 2000

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I 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.	Drug: alvocidib

Arm

Intervention/Treatment

Experimental: Arm I

Drug: alvocidib

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Sciences Building	Chicago	Illinois	United States	60612
2	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637
3	Louis A. Weiss Memorial Hospital	Chicago	Illinois	United States	60640
4	Cancer Care Specialists of Central Illinois, S.C.	Decatur	Illinois	United States	62526
5	Evanston Northwestern Health Care	Evanston	Illinois	United States	60201
6	Lutheran General Hospital	Park Ridge	Illinois	United States	60068
7	Oncology/Hematology Associates of Central Illinois, P.C.	Peoria	Illinois	United States	61602
8	Central Illinois Hematology Oncology Center	Springfield	Illinois	United States	62701
9	Fort Wayne Medical Oncology and Hematology, Inc.	Fort Wayne	Indiana	United States	46885-5099
10	Michiana Hematology/Oncology P.C.	South Bend	Indiana	United States	46617