SWOG clinical trial number
S0350

Phase II Trial of Cisplatin Plus Etoposide Plus Gemcitabine Plus Solumedrol (PEGS) in Peripheral T-Cell Non-Hodgkin's Lymphoma

Closed
Phase
Accrual
100%
Published
Abbreviated Title
NON-HODGKIN: PEGS treatment for Peripheral T-Cell NHL
Activated
09/15/2005
Closed
12/01/2010
Participants
NCORP, Members, Medical Oncologists, Pathologists, Affiliates

Research committees

Lymphoma

Treatment

Cisplatin Etoposide Gemcitabine hydrochloride Methyl Prednisolone

Eligibility Criteria Expand/Collapse

--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

Publication Information Expand/Collapse

2016

T-Cell Lymphoma: Recent Advances in Characterization and New Opportunities for Treatment

C Casulo;O O'Connor;A Shustov;M Fanale;JW Friedberg;JP Leonard;BS Kahl;R Little;L Pinter-Brown;R Advani;S Horwitz Journal of the National Cancer Institute Dec 31;109(2)

PMid: PMID28040682 | PMC number: PMC n/a - Review

2013

Phase II trial of cisplatin plus etoposide plus gemcitabine plus solumedrol (PEGS) in peripheral T-cell non-Hodgkin Lymphoma (SWOG S0350)

D Mahadevan;J Moon;D Persky;F Young;M Leblanc;RI Fisher;TP Miller Cancer 119(2):371-379;

PMid: PMID22833464 | PMC number: PMC3485430

2011

Phase II trial of cisplatin plus etoposide plus gemcitabine plus solumedrol (PEGS) in peripheral T-cell non-Hodgkin lymphoma (SWOG S0350)

D Mahadevan;J Unger;D Persky;C Spier;F Young;M LeBlanc;RI Fisher;TP Miller International Conference on Malignant Lymphoma, 11th annual meeting, oral presentation