CHOP-Rituximab Augmented With GM-CSF in Patients With Previously Untreated Diffuse Large B Cell Non-Hodgkin's Lymphoma - Full Text View

Sponsor:	Massachusetts General Hospital
Collaborators:	Beth Israel Deaconess Medical Center Brigham and Women's Hospital Dana-Farber Cancer Institute Bayer
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00455897

Purpose

The primary goal of this study is to determine the effects (good and bad) of Granulocyte-macrophage colony stimulating factor (GM-CSF) in combination with CHOP-R on diffuse Large B cell Non-Hodgkin's lymphoma (DLBCL). The standard of care for DLBCL is the combination of drugs known as CHOP-Rituximab (CHOP-R). The drugs that make up CHOP-R are the chemotherapy drugs cyclophosphamide, doxorubicin and vincristine, prednisone and rituximab. GM-CSF is a drug that stimulates the immune system by increasing the numbers of white blood cells. Previous research has shown that GM-CSF might help rituximab to be more effective in treating lymphoma.

Condition	Intervention	Phase
Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, Diffuse	Drug: GM-CSF Drug: CHOP Drug: Rituximab	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Trial of CHOP-Rituximab Augmented With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Previously Untreated Diffuse Large B Cell Non-Hodgkin's Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Granulocyte-macrophage colony-stimulating factor Sargramostim Rituximab

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

To determine the safety of GM-CSF when administered in combination with CHOP-R to patients with previously untreated diffuse large B cell non-Hodgkin's lymphoma. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess the response rate, 2-year event-free survival and overall survival with CM-CSF and CHOP-R in this patient population [ Time Frame: TBD ] [ Designated as safety issue: No ]
to analyze the biologic activity of GM-CSF at this dosing schedule and timing. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	December 2006
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Given 11 days before day 1 of cycle 1 for 10 days

Administered as part of standard care

Administered as part of standard treatment

Detailed Description:

Study treatment is divided into 21-day time periods called cycles. Almost all participants will be treated as outpatients unless they have an existing medical problem that requires them to be treated as in inpatient.
The drugs used in this study treatment are standard of care for this type of lymphoma and participants could receive these even if they are not taking part in the study.
Participants will start receiving GM-CSF 11 days before Day 1 of Cycle 1 for 10 days. They will receive the first dose of GM-CSF at the clinic. At least 1 1/2 days after the last GM-CSF injection (Day 1), they will receive chemotherapy (CHOP-R). Eleven days before they start the next cycle (Days 11-20), they will again start to receive GM-CSF injections for 10 days.
Participants will receive up to 6 cycles of study treatment if their disease is responding and they are tolerating the study treatment.
Additional medications may be given to prevent lung infection, return of brain and nervous system disease and tumor lysis syndrome.
Before beginning GM-CSF during each cycle of treatment blood will be drawn to monitor the participants health and to check for side effects.
On Day 1 of each cycle a physical examination and blood tests will be performed. On Day 7 and Day 14 of each cycle, routine blood tests will also be done.
After Cycle 2 and 4 CT scans of the neck, chest, abdomen and pelvis will be performed to check the status of the participants disease.
After 6 cycles of study treatment, the participant will return to the clinic for an End of Treatment Visit. At this visit a physical exam, routine blood tests, and CT scan of neck, chest, abdomen and pelvis will be performed.
The participant will be asked to return to the clinic every 3 months for the first year after study treatment and every 6 months up to 2 years after study treatment for the procedures outline in the End of Treatment Visit.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed diagnosis of diffuse large B cell Non-Hodgkin's lymphoma with characteristic immunophenotypic profile
Patient has not received any prior anti-cancer therapy for lymphoma
Tumor tissue confirmed to express the CD20 antigen by flow cytometry or immunohistochemistry
Measurable disease as defined by a tumor mass of 1cm or greater in one dimension
Stage II (abdominal-not XRT appropriate), III, or IV disease
Age > 18 years
ECOG Performance Status of 0-2
Laboratory parameters as outlined in protocol
Patient agrees to use birth control

Exclusion Criteria:

Known central nervous system involvement by lymphoma
Serious uncontrolled concurrent illness such as active coronary artery disease, severe COPD, CHF, active alcohol abuse, active concurrent malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix
Any evidence of prior natural exposure to Hepatitis B
Active rheumatologic disease which may be exacerbated by GM-CSF
Cardiac ejection fraction less than 45%
Known HIV disease
Patient is pregnant or nursing
Patient is receiving other investigational drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455897

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Massachusetts General Hospital

Beth Israel Deaconess Medical Center

Brigham and Women's Hospital

Dana-Farber Cancer Institute

Bayer

Investigators

Principal Investigator:

Ephraim P Hochberg, MD

Massachusetts General Hosptial

More Information

No publications provided

Responsible Party:	Massachusetts General Hospital ( Ephraim P. Hochberg, MD )
Study ID Numbers:	05-342
Study First Received:	April 2, 2007
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00455897 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

GM-CSF
CHOP-R
Leukine
Sargramostim

DLBLCL
NHL
DLBCL

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Rituximab
Physiological Effects of Drugs
Pharmacologic Actions

Lymphoma, B-Cell
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on November 30, 2009