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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

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 CenterMiami, Florida  33136
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804