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
18 Years
N/A
Both
Lymphoma
Trial Information
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
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed aggressive non-Hodgkin lymphoma with the following subtypes:
- Follicular large cell
- Peripheral T-cell
- Diffuse large cell
- Transformed
- Lymphoblastic
- Burkitt and Burkitt-like
- Stage I-IV disease
- Previously untreated disease
- Must have measurable or evaluable disease
- No CNS involvement by lymphoma
PATIENT CHARACTERISTICS:
- Absolute neutrophils ≥ 1,000/mm ^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin < 2 mg/dL
- Creatinine < 2.0 mg/dL or estimated creatinine clearance ≥ 30 cc/min
- No evidence of grade 3 or more neurosensory or neuromotor dysfunction
- No HIV positivity or hepatitis B or C infection
- No uncontrolled intercurrent disease, including any of the following:
- Arrhythmias
- Angina pectoris
- Class III-IV congestive heart failure (CHF) (CHF symptoms on less than ordinary
exertion or at rest)
- Active infection (fever > 38.2 degrees Celsius unless due to lymphoma)
- Fertile patients must use effective contraception
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Ideal dose of sargramostim administered with dose-dense cyclophosphamide, doxorubicin Hydrochloride, vincristine sulfate, prednisone, and rituximab (R-CHOP), plus fixed-dose of pegfilgrastim
Safety Issue:
No
Principal Investigator
Fernando Cabanillas, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Auxilio Mutuo Cancer Center
Authority:
Unspecified
Study ID:
CDR0000695270
NCT ID:
NCT01297478
Start Date:
January 2006
Completion Date:
Related Keywords:
- Lymphoma
- stage I adult Burkitt lymphoma
- stage III adult Burkitt lymphoma
- stage IV adult Burkitt lymphoma
- stage I adult diffuse large cell lymphoma
- stage III adult diffuse large cell lymphoma
- stage IV adult diffuse large cell lymphoma
- stage I adult lymphoblastic lymphoma
- stage III adult lymphoblastic lymphoma
- stage IV adult lymphoblastic lymphoma
- stage I grade 3 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- peripheral T-cell lymphoma
- contiguous stage II adult Burkitt lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- contiguous stage II adult lymphoblastic lymphoma
- contiguous stage II grade 3 follicular lymphoma
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
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