Phase II Study of Fludarabine and Mitoxantrone, Followed by GM-CSF(Granulocyte-macrophage Colony-stimulating Factor) and Rituximab

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT00208975
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mitoxantrone/Cyclophosphamide, Fludarabine, Rituximab and GM-CSF — DRUG
    Initial patients (n=9) received fludarabine (25 mg/m\^2 intravenously) and mitoxantrone (10 mg/m\^2 intravenously)with sequential administration of GM-CSF(Granulocyte-macrophage colony stimulating factor) (500 µcg subcutaneously) on days 6 and 7 and rituximab (375 mg/m\^2) on day 8. After a change in the protocol, all additional patients (n=6) received fludarabine (25 mg/m\^2 intravenously) and cyclophosphamide (250 mg/m\^2 intravenously)with sequential administration of GM-CSF (500 µcg subcutaneously) on days 6 and 7 and rituximab (375 mg/m\^2) on day 8. All patients received additional doses of GM-CSF (days +8 through +14) were given for patients to reduce variability in neutropenic management.

Study Details

Patients with a low-grade, or indolent (slow-growing) form of non-Hodgkin's lymphoma (NHL) in which the usual survival is between 7-10 years are being asked to take part in this study. Although normally-used combinations of chemotherapy will cause NHL to disappear in 30-40% of patients (called complete response or complete remission), almost all will have their disease return. In this study, researchers tested a combination of anti-cancer agents, fludarabine, rituximab and GM-CSF with mitoxantrone or cyclophosphamide to see if a better and more long-lasting response can be achieved. All of the medications are approved by the Food and Drug Administration (FDA) and are available on the market. The agents we will use are: * Mitoxantrone and fludarabine and cyclophosphamide and fludarabine are combinations of chemotherapy drugs that have been successfully used to treat NHL/CLL (Chronic lymphocytic leukemia) that has returned after treatment and are comparable options for treatment. * Rituximab, a monoclonal antibody that kills cancer cells by binding the CD20 antigen found on the surface of B-cells, commonly used along with chemotherapy drugs to improve response rates in lymphoma treatment. * GM-CSF (granulocyte-macrophage colony stimulating factor, also called sargramostim, GM, or Leukine), a growth factor which stimulates the development of new ("stem") cells. GM-CSF encourages stem cells to divide, specialize, and become active. It is not a normal part of treatment for NHL. Using GM-CSF in NHL treatment is the experimental part of this study. The main purpose of this study is to see if giving GM-CSF along with a standard anti-cancer treatment will work better to reduce cancer, and to look at side effects of the treatment.

Key Dates

Start date
Jul 31, 2002
Status verified
May 2012
Primary completion
Dec 31, 2009
Completion
Sep 30, 2011

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: Fludarabine and Mitoxantrome followed by GM-CSF and Rituximab
    Initial patients (n=9) received fludarabine (25 mg/m2 IV) and mitoxantrone (10 mg/m2 IV)with sequential administration of GM-CSF (500 mcg subcutaneously) on days 6 and 7 and rituximab (375 mg/m2) on day 8. After a change in the protocol, all additional patients (n=6) received fludarabine (25 mg/m2 IV) and cyclophosphamide (250 mg/m2 IV)with sequential administration of GM-CSF (500 mcg subcutaneously) on days 6 and 7 and rituximab (375 mg/m2) on day 8. All patients received dditional doses of GM-CSF (days +8 through +14) were given for patients to reduce variability in neutropenic management.

Primary Outcome Measure

Number of Patients's Who Had Complete Response and Partial Response to the Treatment of Fludarabine and Cyclophosphamide Followed by GM-CSF and Rituximab. [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University Winship Cancer InstituteAtlantaGeorgia30322-

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Emory University Winship Cancer Institute· Atlanta, GA

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