NCT00041327

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for phase_2 lymphoma

Timeline
Completed

Started Oct 2002

Geographic Reach
1 country

3 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

First Submitted

Initial submission to the registry

July 8, 2002

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2002

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

February 3, 2016

Status Verified

February 1, 2016

Enrollment Period

4.2 years

First QC Date

July 8, 2002

Last Update Submit

February 1, 2016

Conditions

Lymphoma

Keywords

stage I adult T-cell leukemia/lymphomastage II adult T-cell leukemia/lymphomastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphoma

Outcome Measures

Primary Outcomes (4)

  • Efficacy

    60 days

  • Duration of response

    3 years

  • Effects on markers of virus replication and expression and immune function

    5 years

  • Toxicity

    1 year

Interventions

filgrastimBIOLOGICAL

5 ug/kg/d

Also known as: Neupogen
recombinant interferon alfaBIOLOGICAL

9 mU subcutaneously per day for one year

EtoposideDRUG

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

Also known as: VP-16
cyclophosphamideDRUG

750 mg/m2 IV on day 5

Also known as: cytoxan
doxorubicin hydrochlorideDRUG

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

Also known as: adriamycin
lamivudineDRUG

150 mg bid

Also known as: epivir
prednisoneDRUG

60 mg/m2 given orally days 1-5

Also known as: deltasone
vincristine sulfateDRUG

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

Also known as: Oncovin
zidovudineDRUG

300 mg bid

Also known as: AZT

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed HTLV-1-associated adult T-cell leukemia/lymphoma (ATLL) * Previously treated ATLL allowed * CD3-positive * Documented HTLV-1 infection by serologic assay (ELISA, Western blot) * Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 50-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count greater than 1,000/mm\^3\* * Platelet count greater than 75,000/mm\^3\* NOTE: \*Unless cytopenia is secondary to ATLL Hepatic: * Transaminase less than 7 times upper limit of normal * Bilirubin less than 2.0 mg/dL (unless secondary to hepatic infiltration with lymphoma or isolated indirect hyperbilirubinemia associated with indinavir) Renal: * Creatinine less than 2.0 mg/dL (unless due to lymphoma) Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study completion * No active opportunistic infection requiring acute therapy * No untreated thyroid disease * No autoimmune disease * No uncontrolled significant psychiatric disease * No other concurrent malignancy except carcinoma in situ of the cervix or non-metastatic nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 24 hours since prior hematologic growth factors Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * Concurrent chronic therapy with potentially myelosuppressive agents allowed * Other concurrent antiretroviral therapy for HIV, hepatitis B, or hepatitis C infection (or other indication) allowed at investigator's discretion for patients receiving therapy prior to study initiation

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

Sponsors & Collaborators

Study Sites (3)

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • Ratner L, Harrington W, Feng X, Grant C, Jacobson S, Noy A, Sparano J, Lee J, Ambinder R, Campbell N, Lairmore M; AIDS Malignancy Consortium. Human T cell leukemia virus reactivation with progression of adult T-cell leukemia-lymphoma. PLoS One. 2009;4(2):e4420. doi: 10.1371/journal.pone.0004420. Epub 2009 Feb 10.

    PMID: 19204798RESULT

MeSH Terms

Conditions

LymphomaPrecursor T-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

FilgrastimInterferon-alphaEtoposideCyclophosphamideDoxorubicinLamivudinePrednisoneVincristineZidovudine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidLeukemiaHematologic Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsInterferon Type IInterferonsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsDaunorubicinAnthracyclinesNaphthacenesAminoglycosidesZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosidesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesThymidine

Study Officials

  • Lee Ratner, MD, PhD

    Washington University Siteman Cancer Center

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

July 8, 2002

First Posted

January 27, 2003

Study Start

October 1, 2002

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

February 3, 2016

Record last verified: 2016-02

Locations

US(3)