NCT00250718

Study: Treatment of Relapsed Lymphoid Malignancies With an Anti-Angiogenic Approach

Phase II Study: Treatment of Relapsed Lymphoid Malignancies With an Anti-angiogenic Approach

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: New Mexico Cancer Research Alliance · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Hodgkin's Lymphoma
• Cancer

Interventions

Type	Name	Description
DRUG	Vincristine	Vincristine should be administered intravenously through a freely-running IV.
DRUG	VP-16	The VP-16 is optional for the first cycle if the patient has delays in obtaining the drug.
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. 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
DRUG	Dexamethasone	Dexamethasone will be administered at 200mg q 14 days. Dexamethasone should be administered over a 1 hour infusion.
DRUG	Levofloxacin	Levofloxacin will be administered at 500 mg PO qd.

Timeline

• Start date: 2004-10-01
• Primary completion: 2008-11-01
• Completion: 2014-05-01
• First posted: 2005-11-08
• Last updated: 2015-08-03
• Results posted: 2015-08-03

Locations

1 site across 1 country: United States