Conditions: Non-Hodgkin's Lymphoma Cancer
Keywords: Non Hodgkin's Lymphoma Phase II Lymphoid malignancies
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 17
Healthy volunteers: no

Brief summary:
1.1 To determine the efficacy of a combination treatment of VP-16, chlorambucil, dexamethasone, and vincristine in patients with relapsed/refractory hematological malignancies.

1.2 To determine the toxicity profile of the above regimen in this patient population.

1.3 Evaluate the effect of low dose administration of chemotherapy on angiogenesis, and correlate this with tumor responses.

Detailed description:
The purpose of the study is to see how effective the combination of chemotherapy drugs VP-16, chlorambucil, dexamethasone, and vincristine is for patients who have blood cancers that have returned or not responded to prior treatment. Some patients may also receive a medication called rituximab if their doctor thinks it is appropriate. This drug combination will be given to study participants in a low dose continuous basis. The study will also collect information about the side effects of the above drug combination on patients with these types of cancers. Previous studies on patients with non-Hodgkin's lymphoma indicate that some patients treated with this drug combination achieved a high response. The aim of this study is to test this drug combination in a controlled setting.

Arms:
arm 1: Treatment with combination therapy as follows:

VP-16 at 50 mg/day, orally for 14 days every 28 days; Chlorambucil at 0.1 mg/kg/day orally for 14 days every 28 days; Vincristine at 2 mg intravenously every 14 days; Dexamethasone at 200 mg intravenously every 24 days; Rituxan (rituximab) at 375 mg/m2 intravenously every 14 day; Levofloxacin at 500 mg orally daily; Diflucan at 200 mg orally daily

At least 2 courses, but no more than 8 courses total, will be administered to each patient

Interventions: intervention 1: Vincristine intervention 2: VP-16 intervention 3: Rituximab intervention 4: Dexamethasone intervention 5: Levofloxacin
Intervention descriptions: intervention 1: Vincristine should be administered intravenously through a freely-running IV. intervention 2: The VP-16 is optional for the first cycle if the patient has delays in obtaining the drug. intervention 3: The total amount of rituximab needed for a patient's entire infusions (one course) will be determined at study entry. A single dose of 375 mg/m2 will be based upon the patient's actual body surface area calculated during the baseline evaluation. The dose level of rituximab will not be adjusted.

Patients will only receive rituximab if their tumors are CD20 positive CLL or NHL.

Rituximab will only be administered to patients if they have previously had less than 8 doses. If a patient is treated with rituxan they should have at least 4 doses intervention 4: Dexamethasone will be administered at 200mg q 14 days. Dexamethasone should be administered over a 1 hour infusion. intervention 5: Levofloxacin will be administered at 500 mg PO qd.

Protocol document: