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Combination Chemotherapy Followed By Antiviral Therapy and Interferon Alfa in Treating Patients With HTLV-1-Related Adult T-Cell Leukemia/Lymphoma

NCT00041327 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2016-02-03

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Antiviral therapy may kill viruses such as HTLV-1 that can cause cancer. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with antiviral drugs and interferon alfa may be effective in treating adult T-cell leukemia/lymphoma.

PURPOSE: Phase II trial to determine the effectiveness of combination chemotherapy followed by antiviral therapy and interferon alfa in treating patients who have adult T-cell leukemia/lymphoma caused by HTLV-1.

Conditions

Interventions

BIOLOGICAL

filgrastim

5 ug/kg/d

BIOLOGICAL

recombinant interferon alfa

9 mU subcutaneously per day for one year

DRUG

Etoposide

50 mg/m2/day continuous 96 hr infusion, days 1-4

DRUG

cyclophosphamide

750 mg/m2 IV on day 5

DRUG

doxorubicin hydrochloride

10 mg/m2/day as a continuous 96-hour infusion days 1-4

DRUG

lamivudine

150 mg bid

DRUG

prednisone

60 mg/m2 given orally days 1-5

DRUG

vincristine sulfate

0.4 mg/m2/day as a 96-hour continuous infusion days 1-4

DRUG

zidovudine

300 mg bid

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • AIDS Malignancy Consortium

    lead NETWORK

Principal Investigators

  • Lee Ratner, MD, PhD · Washington University Siteman Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2006-12-31
Completion
2006-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00041327 on ClinicalTrials.gov