Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Rituximab Pateinets With Aggresive NHL (CHOP-R)

This study has been completed.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Fernando Cabanillas, Auxilio Mutuo Cancer Center
ClinicalTrials.gov Identifier:
NCT01527422
First received: February 3, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Lymphoma
Non Hodgkin's Lymphoma
Drug: Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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"

Resource links provided by NLM:


Further study details as provided by Auxilio Mutuo Cancer Center:

Primary Outcome Measures:
  • Phase I-II Study of Dose Dense of PEG-Filgrastim and GM-CSF combined with CHOP-R [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: January 2006
Study Completion Date: March 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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)
Detailed Description:

1.1 Primary Objective:

  1. 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:

  2. 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527422

Locations
Puerto Rico
Hospital Auxilio Mutuo Cancer Center
San Juan, Puerto Rico, 00919
Sponsors and Collaborators
Fernando Cabanillas
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Fernando Cabanillas, MD Auxilio
Principal Investigator: Fernando Cabanillas, MD Auxilio Mutuo Cancer Center/Hospital Auxilio Mutuo
  More Information

No publications provided

Responsible Party: Fernando Cabanillas, Hematolgy-Oncologyst, Auxilio Mutuo Cancer Center
ClinicalTrials.gov Identifier: NCT01527422     History of Changes
Obsolete Identifiers: NCT01297478
Other Study ID Numbers: NCT01297478
Study First Received: February 3, 2012
Last Updated: February 3, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Auxilio Mutuo Cancer Center:
Aggressive Non-Hodgkin's Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Rituximab
Doxorubicin
Prednisone
Vincristine
Lenograstim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on July 22, 2014