Clinical trial · Interventional
S0350 Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Peripheral T-Cell Non-Hodgkin's Lymphoma
Phase II Trial of Cisplatin Plus Etoposide Plus Gemcitabine Plus Solumedrol (PEGS) in Peripheral T-Cell Non-Hodgkin's Lymphoma
NCT00109928CI-TRIAL-00015737completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, gemcitabine, and methylprednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed stage II, stage III, or stage IV T-cell non-Hodgkin's lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| gemcitabine | Drug | Gemcitabine | ALIAS |
| methylprednisolone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PEGS Treatment
- description
- VP-16 (Etoposide) 40 mg/m2 IV Days 1-4 Methyl Prednisolone 250 mg IV Days 1-4 Cisplatin 25 mg/m2 IV Days 1-4 Gemcitabine 1,000 mg/m2 IV Day 1
- interventionNames
- Drug: cisplatin
- Drug: etoposide
- Drug: gemcitabine
- Drug: methylprednisolone
Primary outcomes (1)
- measure
- 2-year Overall Survival Rate
- timeFrame
- 0-2 years
- description
- The overall survival rate is the percentage of patients who are alive 2 years after registration to the study. Overall survival is defined as the time between study registration and death due to any cause.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of peripheral T-cell non-Hodgkin's lymphoma
* Newly diagnosed, relapsed or progressing disease after 1 prior treatment with a non-platinum based chemotherapy (e.g., CHOP)
* Bulky stage II or stage III or IV disease
* The following histologies are not eligible:
* T-cell prolymphocytic leukemia
* T-cell large granular lymphocytic leukemia
* Any NK-cell leukemia
* Adult T-cell leukemia/lymphoma
* Mycosis fungoides/Sézary syndrome
* Lymphomatoid papulosis
* Nasal-type extranodal NK/T-cell lymphoma
* Enteropathy-type T-cell lymphoma
* Hepatosplenic T-cell lymphoma
* Subcutaneous panniculitis-like T-cell lymphoma
* Angioimmunoblastic T-cell lymphoma
* Primary cutaneous anaplastic large cell lymphoma (ALCL)
* ALCL with CD30, ALK, and EMA expression
* ALCL morphology that fails to express ALK or EMA allowed provided T-cell lineage is confirmed by immunotyping or genetic testing
* Bidimensionally measurable disease
* Adequate samples (e.g., core biopsies, especially multiple core biopsies) from the original diagnostic specimen available
* Needle aspiration or cytology is not considered adequate samples
* No clinical evidence of Central nervous system (CNS) involvement by lymphoma
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin ≤ 2 times upper limit of normal
Renal
* Creatinine clearance ≥ 30 mL/min
Cardiovascular
* No history of congestive heart failure
* No history of myocardial infarction
* No history of unstable angina
* No history of asymptomatic arrhythmias
* Ejection fraction normal by multigated acquisition (MUGA) scan (for patients with questionable cardiac history)
* No other history of impaired cardiac status
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known HIV positivity
* Mild clinical hearing loss allowed provided patient is willing to accept the potential for worsening of hearing loss
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* Must have had a chest x-ray or CT scan of the chest and a CT scan of the abdomen and pelvis within the past 28 days
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 3 weeks since prior biologic therapy
* No concurrent routine use of bone marrow colony-stimulating factors
Chemotherapy
* No other concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy for this cancer
* No concurrent radiotherapy
Surgery
* Not specified
Other
* No prior cytotoxic therapy for this cancer
* Concurrent enrollment in SWOG-8819 or SWOG-8947 allowedReferences
Publications (1)
- RESULTMahadevan D, Unger JM, Spier CM, Persky DO, Young F, LeBlanc M, Fisher RI, Miller TP. Phase 2 trial of combined cisplatin, etoposide, gemcitabine, and methylprednisolone (PEGS) in peripheral T-cell non-Hodgkin lymphoma: Southwest Oncology Group Study S0350. Cancer. 2013 Jan 15;119(2):371-9. doi: 10.1002/cncr.27733. Epub 2012 Jul 25. PMID 22833464