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Clinical Trials/NCT00041327
NCT00041327CompletedPhase 2

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

AIDS Malignancy Consortium6 sites in 1 country19 target enrollmentStarted: October 1, 2002Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
19
Locations
6
Primary Endpoint
Duration of response

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 120 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion 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:
  • 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
  • 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)
  • Creatinine less than 2.0 mg/dL (unless due to lymphoma)
  • 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
  • Not specified
  • 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Duration of response

Time Frame: 3 years

Toxicity

Time Frame: 1 year

Efficacy

Time Frame: 60 days

Effects on markers of virus replication and expression and immune function

Time Frame: 5 years

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
AIDS Malignancy Consortium
Sponsor Class
Network
Responsible Party
Sponsor

Study Sites (6)

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