Trial | NCT01527422  Report issue

Title

Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Rituximab Pateinets With Aggresive NHL
Protocol CCAM 05-02 " Phase I-II Study of Dose Dense of PEG Filgrastim and GM-CSF as Support for Dose Desnse CHOP-R Front Line Therapy for Aggressive Non Hodgkin's Lymphoma"

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
We now propose to investigate the combination of CHOP-Rituxan plus PEG-Filgrastim (PEG-filgrastim) and GM-CSF. PEG-Filgrastim would be given in order to allow us to administer the chemotherapy courses every 2 weeks with the practical advantage of requiring only one dose of PEG-filgrastim instead of daily doses of G-CSF.
1.1 Primary Objective:

To identify the ideal dose of the combination of CHOP-R with PEG-Filgrastim (Neulasta) using first a fixed dose of Neulasta and an escalating dose of GM-CSF (Leukine) up to 250 mcg. When that dose is reached, if possible, the dose of Neulasta will be increased stepwise. CHOP-R will be delivered every 14 days at a fixed standard dose with dose adjustments of PEG-Filgrastim and GM-CSF upwards and downwards according to nadir or zenith blood counts.

1.2 Secondary Objective:

To generate preliminary pilot data as to the effectiveness of the regimen in inducing very early remissions as measured by the CT-PET scan technique.
Study Started
Jan 31
2006
Primary Completion
Nov 30
2010
Study Completion
Mar 31
2011
Last Update
Feb 07
2012
Estimate

Drug Cyclophosphamide, Doxorubicin, Vincristine and Prednisone

Rituximab will be administered on day 1 of courses 1-6 at 375 mg/m2 concurrently with CHOP-R.All patients will receive antiemetics priorchemotherapy.Courses will be repeated every 14 days.If blood counts don't allow re-treatment on day 14 the counts will be repeated at least twice per week until recovery allows re-treatment.The aim is to achieve a dose that will be as close as possible to 250 mcg and that will result in grade 0 or grade 1A or 1B toxicity at the most. The dose of PEG-Filgrastim will initially be fixed at 3 mg until dose level +3 is reached (which includes 250 mcg Leukine) at which time the dose of Neulasta will be escalated if necessary. All patients will receive Neulasta as a subcutaneous injection on the day 3.

  • Other names: Cyclophosphamide (Cytoxan), Doxorubicin (Adryamicin), Vincristine (Oncovin), Prednisone, Rituximab (Rituxan), Peg Filgrastim[Neulasta (G-CSF or GCSF)], Leukine (Sargramostim)

Criteria 

Inclusion Criteria:

Patients with previously untreated aggressive non-Hodgkin's Lymphoma. Aggressive histologies include follicular large cell, diffuse large cell, peripheral T cell, transformed lymphomas, Lymphoblastic lymphomas, Burkitt and Burkitt like lymphomas.
Must have measurable or evaluable disease.
Stage I-IV patients are eligible
Patients must be 18 years or older.
No evidence of grade 3 or more neurosensory or neuromotor dysfunction (see appendix- toxicity criteria)
Written Consent

Exclusion Criteria:

HIV positive patients and those with Hepatitis B or C will be excluded from this protocol.
Patients with inadequate bone marrow and organ function as defined below:
Neutrophils <1,000/l
Platelets <100,000/l
Billirubin >2
Creatinine >2.0 or estimated CrCl <30 cc/min
CNS involvement by Lymphoma.
Uncontrolled intercurrent disease including arrhythmias, angina pectoris, Class III-IV Congestive heart failure (CHF symptoms on less than ordinary exertion or at rest) or active infection.
Active infection or fever > 38.2 degrees C unless due to lymphoma.
Subject is not using adequate contraceptive precautions.
Pregnancy or breast feeding
No Results Posted