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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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
recombinant interferon alfa
Etoposide
cyclophosphamide
doxorubicin hydrochloride
lamivudine
prednisone
vincristine sulfate
zidovudine
Sponsored by
AIDS Malignancy Consortium
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring stage I adult T-cell leukemia/lymphoma, stage II adult T-cell leukemia/lymphoma, stage III adult T-cell leukemia/lymphoma, stage IV adult T-cell leukemia/lymphoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USC/Norris Comprehensive Cancer Center and Hospital
  • University of Miami Sylvester Comprehensive Cancer Center
  • Siteman Cancer Center at Barnes-Jewish Hospital

Outcomes

Primary Outcome Measures

Efficacy
Duration of response
Effects on markers of virus replication and expression and immune function
Toxicity

Secondary Outcome Measures

Full Information

First Posted
July 8, 2002
Last Updated
February 1, 2016
Sponsor
AIDS Malignancy Consortium
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00041327
Brief Title
Combination Chemotherapy Followed By Antiviral Therapy and Interferon Alfa in Treating Patients With HTLV-1-Related Adult T-Cell Leukemia/Lymphoma
Official Title
Phase II Trial Of Induction Therapy With EPOCH Chemotherapy And Maintenance Therapy With Combivir/Interferon ALPHA-2a For HTLV-1 Associated T-Cell Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AIDS Malignancy Consortium
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Determine the efficacy of etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (EPOCH) followed by lamivudine, zidovudine, and interferon alfa, in terms of response rate, in patients with HTLV-1-associated adult T-cell leukemia/lymphoma. Determine the duration of response in patients treated with this regimen. Determine the toxicity of this regimen in these patients. Determine the effect of this regimen on markers of virus replication and expression and immune function in these patients. OUTLINE: This is a multicenter study. Patients receive EPOCH chemotherapy comprising etoposide, vincristine, and doxorubicin IV continuously on days 1-5, cyclophosphamide IV over 30 minutes on day 5, and oral prednisone on days 1-5. Patients also receive filgrastim (G-CSF) subcutaneously (SC) daily beginning on day 7 and continuing until blood counts recover. Treatment repeats every 21-28 days for at least 2 courses beyond best response or for up to 6 courses in the absence of unacceptable toxicity, disease progression, or stable disease. Beginning 1 month after completion of EPOCH, patients receive oral lamivudine and zidovudine twice daily and interferon alfa SC daily continuously for 1 year. Patients are followed monthly for 1 year, every 2 months for 1 year, and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 10-32 patients will be accrued for this study within 1-2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
stage I adult T-cell leukemia/lymphoma, stage II adult T-cell leukemia/lymphoma, stage III adult T-cell leukemia/lymphoma, stage IV adult T-cell leukemia/lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Other Intervention Name(s)
Neupogen
Intervention Description
5 ug/kg/d
Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa
Intervention Description
9 mU subcutaneously per day for one year
Intervention Type
Drug
Intervention Name(s)
Etoposide
Other Intervention Name(s)
VP-16
Intervention Description
50 mg/m2/day continuous 96 hr infusion, days 1-4
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Other Intervention Name(s)
cytoxan
Intervention Description
750 mg/m2 IV on day 5
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Other Intervention Name(s)
adriamycin
Intervention Description
10 mg/m2/day as a continuous 96-hour infusion days 1-4
Intervention Type
Drug
Intervention Name(s)
lamivudine
Other Intervention Name(s)
epivir
Intervention Description
150 mg bid
Intervention Type
Drug
Intervention Name(s)
prednisone
Other Intervention Name(s)
deltasone
Intervention Description
60 mg/m2 given orally days 1-5
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Other Intervention Name(s)
Oncovin
Intervention Description
0.4 mg/m2/day as a 96-hour continuous infusion days 1-4
Intervention Type
Drug
Intervention Name(s)
zidovudine
Other Intervention Name(s)
AZT
Intervention Description
300 mg bid
Primary Outcome Measure Information:
Title
Efficacy
Time Frame
60 days
Title
Duration of response
Time Frame
3 years
Title
Effects on markers of virus replication and expression and immune function
Time Frame
5 years
Title
Toxicity
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Ratner, MD, PhD
Organizational Affiliation
Washington University Siteman Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089-9181
Country
United States
Facility Name
University of Miami Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19204798
Citation
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.
Results Reference
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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

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