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

NCT00250718 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2015-08-03

Study results available
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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.

Conditions

  • Non-Hodgkin's Lymphoma
  • Cancer

Interventions

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.

Sponsors & Collaborators

  • New Mexico Cancer Research Alliance

    lead OTHER

Principal Investigators

  • Dulcinea Quintana, MD · UNM Cancer Center

  • Robert Hromas, MD · University of Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2008-11-30
Completion
2014-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00250718 on ClinicalTrials.gov