Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T-Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Intervention: Cyclophosphamide; Mesna; Vincristine; Methotrexate; Ara-C; Dexamethasone; G-CSF; Doxil
Intervention description: Cycle 1: 300 mg/m^2 by vein Over 3 Hours Twice Daily on Days 1, 2, and 3.; Cycle 1: 600 mg/m^2 by vein Continuous Infusion Over Days 1, 2, and 3.; Cycle 1: 1.4 mg/m^2 by vein On Day 4 and 11.; Cycle 1 and 2: 200 mg/m^2 by vein Over 2 Hours on Day 1, followed by 800 mg/m^2 IV Over 22 Hours on Day 1.; Cycle 1 and 2: 3 Gm/m^2 Over 2 Hours Twice Daily On Days 2 and 3.; Cycle 1: 40 mg by vein or by mouth daily on Days 1-4 and 11-14.; Cycle 1 and 2: 300 or 480 mcg subcutaneously 24 hours after end of Day 4 vincristine.; Cycle 1: 25 mg/m^2 by vein Over 1 Hour on Day 2.
Intervention MeSH terms: Cytarabine; Dexamethasone; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Methotrexate; Vincristine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lymphoma; Peripheral T Cell; HCVIDDOXIL Regimen; ARA-C; Cytosar; DepoCyt; Cytosine arabinosine hydrochloride; Pegylated Liposomal Doxorubicin; Doxorubicin hydrochloride; Doxil; Cyclophosphamide; Cytoxan; Neosar; Dexamethasone; Decadron; Mesna; Methotrexate; Vincristine; G-CSF; Filgrastim; Neupogen

Summary:

      The goal of this clinical research study is to learn if treatment with two types of
      chemotherapy combinations can help to control peripheral T-cell lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Confirmed diagnosis of previously untreated T-cell Non Hodgkin's Lymphomas and NK
             lymphomas, with the exception of cluster of differentiation antigen 30 (CD30+) alk1+
             T-anaplastic large cell lymphoma (ALCL). Patients with skin involvement alone are also
             excluded. For patients with skin involvement as part of systemic disease, prior
             topical treatment only is allowed.

          2. Patients with a performance status of 3 or less (Zubrod Scale - see Appendix D).

          3. Serum bilirubin </= 1.5 mg/dl and serum creatinine </= 2.0 mg/dl unless due to
             lymphoma; Absolute neutrophil count (ANC) >/= 1000 mm^3 and platelets >/= 100,000 mm^3
             unless due to lymphoma.

          4. Cardiac ejection fraction 50% or greater by multigated radionuclide angiography (MUGA)
             or echocardiogram.

          5. Ages 18 and older.

          6. Patients must be willing to receive transfusions of blood products.

        Exclusion Criteria:

          1. Patients with CD30+ alk1+ T-anaplastic large cell lymphoma (ALCL) or patients with
             skin involvement alone.

          2. Pregnancy

          3. HIV positive serology

          4. Central nervous system (CNS) involvement

          5. Co-morbid medical, such as Child's Class C liver cirrhosis, end-stage renal disease,
             and symptomatic congestive heart failure, or psychiatric illnesses that preclude
             treatment with intense dose chemotherapy as determined by the primary investigator

          6. Concurrent or previous malignancy whose prognosis is poor (<90% probability of
             survival at 5 years)