Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine Sulfate, Prednisone, Rituximab, Pegfilgrastim, and Sargramostim as Front-Line Therapy in Treating Patients With Aggressive Non-Hodgkin Lymphoma
Recruitment status was Recruiting
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Biological therapies, such as pegfilgrastim and sargramostim, may stimulate the immune system in different ways and stop cancer cells from growing. Giving combination chemotherapy together with rituximab and biological therapy may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of sargramostim when given together with pegfilgrastim, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone, and rituximab as front-line therapy in treating patients with aggressive non-Hodgkin lymphoma.
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
Other: R-CHOP regimen
Radiation: external beam radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I-II Study of Dose Dense of PEG-Filgrastim and GM-CSF as Support for Dose Dense CHOP-R Front Line Therapy for Aggressive Non-Hodgkin's Lymphoma|
- Ideal dose of sargramostim administered with dose-dense cyclophosphamide, doxorubicin Hydrochloride, vincristine sulfate, prednisone, and rituximab (R-CHOP), plus fixed-dose of pegfilgrastim [ Designated as safety issue: No ]
- Effectiveness of regimen in inducing very early remissions as measured by the CT-PET scan [ Designated as safety issue: No ]
|Study Start Date:||January 2006|
|Estimated Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
- To identify the ideal dose of the combination of dose-dense cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone, and rituximab (R-CHOP) front-line therapy with first a fixed-dose of pegfilgrastim and an escalating-dose of sargramostim in patients with aggressive stage I-IV non-Hodgkin lymphoma.
- To generate preliminary pilot data as to the effectiveness of this regimen in inducing very early remissions as measured by the CT-PET scan.
OUTLINE: This is a dose-escalation study of sargramostim.
Patients receive rituximab IV on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 15 minutes, doxorubicin Hydrochloride IV over 15 minutes, and vincristine sulfate IV over 15 minutes on day 2 and oral prednisone once daily on days 1-5. Patients also receive pegfilgrastim subcutaneously (SC) on day 3 and sargramostim SC 3 days a week. Treatment repeats every 14 days for up to 6* courses in the absence of unacceptable toxicity.
NOTE: *Patients with stage IA presentation with low beta 2-microglobulin and low LDH are treated with 3 courses of CHOP-R followed by involved-field radiation.
Blood samples are collected periodically for laboratory studies.
After completion of study therapy, patients are followed up for at least 1 month.
|Centro de Cancer del Hospital Auxilio Mutuo||Recruiting|
|San Juan, Puerto Rico, 00936-2712|
|Contact: Clinical Trial Coordinator 787-771-7933, ext. 3569 firstname.lastname@example.org|
|Study Chair:||Fernando Cabanillas, MD||Auxilio Mutuo Cancer Center|