NCT00003039

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_2 lymphoma

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1997

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2000

Completed
4.4 years until next milestone

First Posted

Study publicly available on registry

September 6, 2004

Completed
Last Updated

February 5, 2013

Status Verified

April 1, 2000

Enrollment Period

2.6 years

First QC Date

November 1, 1999

Last Update Submit

February 4, 2013

Conditions

Lymphoma

Keywords

recurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomarecurrent mantle cell lymphoma

Study Arms (1)

Arm I

EXPERIMENTAL

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

Interventions

alvocidibDRUG
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

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

Sponsors & Collaborators

Study Sites (10)

Clinical Sciences Building

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637, United States

Location

Louis A. Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

Cancer Care Specialists of Central Illinois, S.C.

Decatur, Illinois, 62526, United States

Location

Evanston Northwestern Health Care

Evanston, Illinois, 60201, United States

Location

Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

Oncology/Hematology Associates of Central Illinois, P.C.

Peoria, Illinois, 61602, United States

Location

Central Illinois Hematology Oncology Center

Springfield, Illinois, 62701, United States

Location

Fort Wayne Medical Oncology and Hematology, Inc.

Fort Wayne, Indiana, 46885-5099, United States

Location

Michiana Hematology/Oncology P.C.

South Bend, Indiana, 46617, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaLymphoma, Mantle-Cell

Interventions

alvocidib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Study Officials

  • Todd M. Zimmerman, MD

    University of Chicago

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 1, 1999

First Posted

September 6, 2004

Study Start

September 1, 1997

Primary Completion

April 1, 2000

Last Updated

February 5, 2013

Record last verified: 2000-04

Locations

US(10)