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| ID | Type | Description | Link |
|---|---|---|---|
| SCCC-2006068 |
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RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Combinations of biological substances in denileukin diftitox may be able to carry cancer-killing substances directly to non-Hodgkin lymphoma cells. Giving combination chemotherapy together with denileukin diftitox may kill more cancer cells.
PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with denileukin diftitox works in treating patients with newly diagnosed T-cell non-Hodgkin lymphoma.
OBJECTIVES:
Primary
Secondary
OUTLINE:
Patients undergo tumor tissue and blood sample collection periodically for correlative studies. Samples are analyzed for CD25-positive or -negative expression and response rate via flow cytometry.
After completion of study treatment, patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| denileukin diftitox | Biological | |||
| cyclophosphamide | Drug | |||
| cytarabine | Drug | |||
| doxorubicin hydrochloride | Drug | |||
| leucovorin calcium | Drug | |||
| methotrexate | Drug | |||
| prednisone | Drug | |||
| vincristine sulfate |
| Measure | Description | Time Frame |
|---|---|---|
| Failure-free survival |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate (CR, CRu, and PR) | ||
| Overall survival | ||
| Toxicity profile |
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DISEASE CHARACTERISTICS:
Confirmed diagnosis of peripheral T-cell non-Hodgkin lymphoma
No CD30-positive ALK 1-positive T-anaplastic large cell lymphoma
No skin only involvement
No localized NK/T-cell lymphoma
No adult T-cell leukemia/lymphoma
No known CNS involvement
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
Life expectancy > 3 months
ANC > 1,000/mm^3 (unless due to lymphoma)
Platelets > 100,000/mm^3 (unless due to lymphoma)
Serum bilirubin ≤ 2.0 mg/dL (unless due to lymphoma)
Serum creatinine ≤ 1.5 mg/dL (unless due to lymphoma)
Albumin ≥ 3.0 g/dL
Cardiac ejection fraction ≥ 50% by MUGA or echocardiogram
Not pregnant or nursing
Negative serum or urine β-HCG at screening
Women and male partners of child-bearing potential must practice an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch) before study entry and throughout the study period
Willing to receive transfusions of blood products
No HIV-positive serology
No uncontrolled intercurrent illness including, but not limited to, any of the following:
No other prior or concurrent malignancy with a poor prognosis (i.e., < 90% probability of survival at 5 years) or that is actively being treated
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Maricer Escalon, MD, MS | University of Miami Sylvester Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami | Florida | 33136 | United States |
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| Drug |
| protein expression analysis | Genetic |
| flow cytometry | Other |
| laboratory biomarker analysis | Other |
| Correlation of response with CD25 expression |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D007119 | Immunoblastic Lymphadenopathy |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| 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 |
| D000072281 | Lymphadenopathy |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
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| ID | Term |
|---|---|
| C078456 | denileukin diftitox |
| D003520 | Cyclophosphamide |
| D003561 | Cytarabine |
| D004317 | Doxorubicin |
| D002955 | Leucovorin |
| D008727 | Methotrexate |
| D011241 | Prednisone |
| D014750 | Vincristine |
| D005434 | Flow Cytometry |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D000630 | Aminopterin |
| 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 |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D002469 | Cell Separation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003592 | Cytophotometry |
| D005470 | Fluorometry |
| D008163 | Luminescent Measurements |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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