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| ID | Type | Description | Link |
|---|---|---|---|
| U01CA070019 | U.S. NIH Grant/Contract | View source | |
| CDR0000069469 | Other Identifier | NCI |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | 5 ug/kg/d |
| |
| recombinant interferon alfa | Biological | 9 mU subcutaneously per day for one year | ||
| Etoposide | Drug | 50 mg/m2/day continuous 96 hr infusion, days 1-4 |
| |
| cyclophosphamide | Drug | 750 mg/m2 IV on day 5 |
| |
| doxorubicin hydrochloride | Drug | 10 mg/m2/day as a continuous 96-hour infusion days 1-4 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | 60 days | |
| Duration of response | 3 years | |
| Effects on markers of virus replication and expression and immune function | 5 years | |
| Toxicity | 1 year |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed HTLV-1-associated adult T-cell leukemia/lymphoma (ATLL)
CD3-positive
Documented HTLV-1 infection by serologic assay (ELISA, Western blot)
Measurable or evaluable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Lee Ratner, MD, PhD | Washington University Siteman Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | 90089-9181 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19204798 | Result | 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. |
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| lamivudine |
| Drug |
150 mg bid |
|
| prednisone | Drug | 60 mg/m2 given orally days 1-5 |
|
| vincristine sulfate | Drug | 0.4 mg/m2/day as a 96-hour continuous infusion days 1-4 |
|
| zidovudine | Drug | 300 mg bid |
|
| University of Miami Sylvester Comprehensive Cancer Center |
| Miami |
| Florida |
| 33136 |
| United States |
| Siteman Cancer Center at Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D016898 | Interferon-alpha |
| D005047 | Etoposide |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D019259 | Lamivudine |
| D011241 | Prednisone |
| D014750 | Vincristine |
| D015215 | Zidovudine |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D000617 | Aminoglycosides |
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D013936 | Thymidine |
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