Study: Treatment of Relapsed Lymphoid Malignancies With an Anti-Angiogenic Approach
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study: Treatment of Relapsed Lymphoid Malignancies With an Anti-angiogenic Approach|
- Either complete or partial remission, or stabilization of disease pending complete recovery of non hematologic toxicity (aside from alopecia), with return of blood cell counts to > 1000 granulocytes and > 50,000 platelets. [ Time Frame: Progressive disease during therapy after 2 cycles. ] [ Designated as safety issue: Yes ]
- Toxicity will be evaluated at each course of therapy. [ Time Frame: end of 2 cycles (cycle = 28 days) ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2004|
|Study Completion Date:||May 2014|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Experimental: Arm 1 Combination Tx
Treatment with combination therapy as follows: VP-16 50mg/d POx 14 days q 28 days Chlorambucil 0.1mg/kg/d POx 14 days q 28 days Vincristine 2mgIV 1 14 days Dexamethasone 200mg IV q 24 days Rituxan (rituximab) 375 mg/m3 IVI 1 14 days Levofloxacin 500 mg PO qd Diflucan 200 mg PO qd
Vincristine should be administered intravenously through a freely-running IV. It will be administered 2mg IV q 14 days.
Other Name: OncovinDrug: VP-16
The VP-16 is optional for the first cycle if the patient has delays in obtaining the drug. Dose and schedule 50 mg/d P.O. x 14 days q 28 days.
Other Names:Drug: Rituximab
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.
Other Name: RituxanDrug: Dexamethasone
Dexamethasone will be administered at 200mg q 14 days. Dexamethasone should be administered over a 1 hour infusion.
Other Name: decadronDrug: Levofloxacin
Levofloxacin will be administered at 500 mg PO qd.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00250718
|United States, New Mexico|
|University of New Mexico Cancer Center|
|Albuquerque, New Mexico, United States, 87131|
|Principal Investigator:||Dulcinea Quintana, MD||UNM Cancer Center|
|Study Chair:||Robert Hromas, MD||University of Florida|