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
18 Years
N/A
Both
Lymphoma
Trial Information
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
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.
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:
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy
Outcome Time Frame:
60 days
Safety Issue:
No
Principal Investigator
Lee Ratner, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Washington University Siteman Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000069469
NCT ID:
NCT00041327
Start Date:
October 2002
Completion Date:
December 2006
Related Keywords:
- Lymphoma
- 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
- Leukemia, T-Cell
- Leukemia-Lymphoma, Adult T-Cell
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, T-Cell
Name | Location |
|---|---|
| University of Miami Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |
| Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
