Clinical trial NCT00632827
Conditions: Peripheral T-Cell Lymphoma
Sponsor: University of California, San Francisco
Start date: 2008-07-01; Completion date: 2016-06-23
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study examines the use of denileukin diftitox (Ontak) for patients with peripheral T-cell lymphoma who are candidates for autologous stem cell transplants.

Detailed description:
This protocol proposes first to increase the proportion of patients who achieve adequate initial disease control and are able to proceed to autologous stem cell transplant (ASCT) in first complete or partial remission. It administers intensive and novel induction therapy.

Two cycles of gemcitabine, vinorelbine, Doxil (GND) will be used followed by two cycles of augmented dose Cyclophosphamide (CHOP) plus high-dose methotrexate (MTX). Patients will be restaged after two cycles of GND to assess response to GND alone and again after the second cycle of augmented CHOP/high-dose MTX.

Those achieving a remission status will receive intensive consolidation with HiDAC/etoposide followed by stem cell mobilization. A five-day course of denileukin diftitox (Ontak) will be administered at and will serve as an in vivo purge. This will be followed by autologous stem cell transplant.

Those not achieving partial remission or better following the four induction courses will receive 2 cycles of denileukin diftitox(Ontak) for 5 days. Those achieving partial remission or better to this regimen will go on to consolidation/mobilization and autologous stem cell transplant.

Post-transplant, denileukin diftitox will also be used as an additional module of therapy.

Arms: arm 1: (1) Induction Chemo A; Two 21-day cycles of Gemcitabine 1000 mg/m2 days (D) 1, 8, Navelbine 20 mg/m2 D1, D8; Doxil 15 mg/m2 Days 1 and 8, G-CSF Days 4-6 and 10-15 (2) Induction Chemo B: Two 21-day cycles of Cyclophosphamide 2000 mg/m2 day 1; Doxorubicin 50 mg/m2 day 1; Vincristine 1.4 mg/m2 day 1; Prednisone 100 mg/m2 days 1-5; Methotrexate 3000 mg/m2 IV over 4h day 15; Leucovorin rescue (3) Disease Evaluation (4) High-dose Consolidation Chemo, high dose Ara-C, Denileukin diftitox (Ontak) and Stem Cell Collection (5) Consolidation Cytarabine 2000 mg/m2 IV over 2 h q 12h days 1-4, Etoposide 40 mg/m2 continuous intravenous infusion (CIVI), days 1-4, Denileukin Diftitox (Ontak) 9 mcg/kg/day days 6-10, G-CSF 10 mcg/kg/day day 14+, Stem cell collection day 22 (6) Autologous Stem Cell Transplant Carmustine 550 mg/m2 day -6, Etoposide 60 mg/kg IV over 4h day -4, Cyclophosphamide 100 mg/kg day -2, Stem cell infusion D0 (7) Post-transplant: Denileukin Diftitox (Ontak) 18 mcg/kg/day days 1- 5
Interventions: intervention 1: Gemcitabine intervention 2: Navelbine intervention 3: Doxorubicin Hydrochloride Liposome Injection intervention 4: Granulocyte-colony stimulating factor (G-CSF) intervention 5: Pegfilgrastim intervention 6: Cyclophosphamide intervention 7: Vincristine intervention 8: Leucovorin intervention 9: Methotrexate intervention 10: Doxorubicin Hydrochloride intervention 11: Cytarabine intervention 12: Etoposide intervention 13: Carmustine intervention 14: Denileukin diftitox
Intervention descriptions: intervention 1: Chemotherapy medication used to treat a number of types of cancer intervention 2: Navelbine is an chemotherapy medication used to treat a number of types of cancer intervention 3: Doxorubicin Hydrochloride Liposome Injection is an anti-cancer chemotherapy drug intervention 4: G-CSF is a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream. intervention 5: Colony-stimulating factor 3 (CSF 3) and, is a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream. May be used instead of G-CSF intervention 6: Cancer medication that interferes with the growth and spread of cancer cells in the body intervention 7: Vincristine is a chemotherapy medication used to treat cancer. Vincristine works by stopping the cancer cells from separating into 2 new cells to stops the growth of the cancer intervention 8: Leucovorin is used to prevent harmful effects of methotrexate when methotrexate is used to treat certain types of cancer. intervention 9: Methotrexate is a chemotherapy medication used to treat cancer intervention 10: Doxorubicin Hydrochloride is a chemotherapy medication used to treat cancer intervention 11: Medication used to treat acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), chronic myelogenous leukemia (CML), and non-Hodgkin's lymphoma intervention 12: Etoposide is a is a chemotherapy medication used to treat cancer intervention 13: Carmustine is a chemotherapy medication used to treat cancer intervention 14: Denileukin diftitox is an antineoplastic agent, an engineered protein combining Interleukin-2 and Diphtheria toxin. Denileukin diftitox could bind to Interleukin-2 receptors and introduce the diphtheria toxin into cells that express those receptors, killing the cells

Protocol documents: