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The links after "Participants" show which Southwest Oncology Group institutions are eligible to participate in this study.

The orange "Where is This Study Open?" tab at the bottom of the page shows the institutions whose Institutional Review Boards (IRBs) have approved the protocol so that it can be opened at that institution. Clicking on the Institution Name will show the points of contact for information about this study at that institution.

S0350 - Phase II
Phase II Trial of Cisplatin Plus Etoposide Plus Gemcitabine Plus Solumedrol (PEGS) in Peripheral T-Cell Non-Hodgkin's Lymphoma
Treatment: Cisplatin, Etoposide, Gemcitabine hydrochloride, Methyl Prednisolone

Disease Committee: Lymphoma

Study Coordinator(s): Daruka Mahadevan, M.D.,Ph.D., Daniel O. Persky, M.D., Catherine Spier, M.D.

Participants: Members, CCOP, Affiliates, Medical Oncologists, Pathologists

Eligibility Criteria: --Must have either newly diagnosed NHL of T-cell lineage or relapsed or progressing disease after one prior treatment with a non-platinum based chemotherapy (e.g. CHOP). NHL of T-cell lineage includes extranodal types (i.e. extranodal NK/T-cell lymphoma nasal type, enteropathy-type T-cell lymphoma, hepatosplenic T-cell lymphoma, and subcutaneous panniculitis-like T-cell lymphoma) and nodal types (i.e. angioimmunoblastic T-cell lymphoma). Patients with transformed cutaneous T-cell lymphoma (CTCL) to peripheral T-cell lymphoma (PTCL) with systemic involvement (not local skin transformation) are also eligible.

--Must have Stage III, Stage IV, or bulky Stage II extent of disease;

--Must provide adequate sections (one H&E stained section AND a paraffin block, two 0.6 cm tissue corse, or 20 unstained paraffin slides) from the original specimen must be made available for pathology review;

--Consent to the tissue and serum sample submission requirements as outlined in Section 15.4 is encouraged, but not required for study entry.

--Must have bidimensionally measurable disease documented w/in 28 days prior to registration, non-measurable disease must be assessed w/in 42 days prior to registration;

--Must have received no more than one prior treatment with a non-platinum based chemotherapy (e.g. CHOP) for their PTCL-NHL

--Prior biological therapy must be completed at least 3 weeks prior to registration;

--Labs (w/in 28 days prior to registration): : ANC >/= 1,500/mcL, platelets >/=75,000/mcL, serum bilirubin </= 2 X IULN; measured OR estimated creatinine clearance >/= 30 mL/min

--Must have bilateral or unilateral bone marrow aspirate and biopsy performed w/in 42 days prior to registration;

--Must not have plans for other concommitant chemotherapeutic agents or RT;

-Must not be pregnant or nursing;

-Patients with mild hearing loss must be willing to accept the potential for worsening of symptoms;

--Must have chest x-ray or CT scan of the chest and a CT scan or the abdomen and pelvis w/in 28 days prior to registration;

--Must not have clinical evidence of CNS involvement by lymphoma; must not have a history of impaired cardiac status;

--Must be HIV negative;

--Mo prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for 5 years;

--Age 18 or older

--Performance status 0-2

Activation Date: 9/15/2005

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