drugset / Trial / NCT00822120
S0816 Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma
Phase 2
Completed
371 enrolled
SWOG Cancer Research Network
National Cancer Institute (NCI) · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
RATIONALE: Drugs used in chemotherapy 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. G-CSF may help lessen the side effects in patients receiving chemotherapy. Imaging procedures, such as fludeoxyglucose F 18-PET/CT imaging, may help doctors predict how patients will respond to treatment. PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well it works in assessing response to combination chemotherapy and allow doctors to plan better additional further treatment in treating patients with stage III or stage IV Hodgkin lymphoma.
Timeline
- Start
- 2009-07
- Primary completion
- 2016-04-30
- Completion
- 2022-06-30
Publications
- Kreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3.
- Stephens DM, Li H, Schoder H, Straus DJ, Moskowitz CH, LeBlanc M, Rimsza LM, Bartlett NL, Evens AM, LaCasce AS, Barr PM, Knopp MV, Hsi ED, Leonard JP, Kahl BS, Smith SM, Friedberg JW. Five-year follow-up of SWOG S0816: limitations and values of a PET-adapted approach with stage III/IV Hodgkin lymphoma. Blood. 2019 Oct 10;134(15):1238-1246. doi: 10.1182/blood.2019000719.
- Hsi ED, Li H, Nixon AB, Schoder H, Bartlett NL, LeBlanc M, Smith S, Kahl BS, Leonard JP, Evens AM, Scott DW, Rimsza LM, Friedberg JW. Serum levels of TARC, MDC, IL-10, and soluble CD163 in Hodgkin lymphoma: a SWOG S0816 correlative study. Blood. 2019 Apr 18;133(16):1762-1765. doi: 10.1182/blood-2018-08-870915. Epub 2019 Feb 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bleomycin | Unknown | 10 unknown | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 650 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 1250 mg/m2 | Intravenous |
| Comparator | Dacarbazine | Small molecule | 375 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 25 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 35 mg/m2 | Intravenous |
| Subject | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Etoposide | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Prednisone | Other / unclassified | 40 mg/m2 | — |
| Comparator | Vinblastine | Small molecule | 6 mg/m2 | Intravenous |
| Subject | Vincristine | Small molecule | 1.4 mg/m2 | Intravenous |
| Subject | procarbazine | Small molecule | 100 mg/m2 | Oral |
| Background | filgrastim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |