Study: Treatment of Relapsed Lymphoid Malignancies With an Anti-Angiogenic Approach
Information source: University of New Mexico
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-Hodgkin's Lymphoma; Cancer
Intervention: Vincristine (Drug); VP-16 (Drug); Rituximab (Drug); Dexamethasone (Drug); Levofloxacin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of New Mexico Official(s) and/or principal investigator(s):
Robert Hromas, MD, Principal Investigator, Affiliation: University of New Mexico
Overall contact:
Leanne Gideon, Phone: 505-272-5688, Email: lgideon@salud.unm.edu
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.
Clinical Details
Official title: Phase II Study: Treatment of Relapsed Lymphoid Malignancies With an Anti-angiogenic Approach
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Primary outcome: 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.
Secondary outcome: Toxicity will be evaluated at each course of therapy.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- All patients, 18 years of age or older, with Hodgkin's lymphoma, NHL, myeloma, or CLL
are eligible.
- Patients must have a life expectancy of at least 12 weeks.
- Patients must have a Zubrod performance status of 0-2.
- Patients must sign an informed consent.
- Patients should have adequate bone marrow function defined by an absolute peripheral
granulocyte count of > 1,000 or cells/mm3 and platelet count >50,000/mm3 and absence
of a regular red blood cell or platelet transfusion requirement.
- Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and
SGOT or SGPT < two times the upper limit of normal, and adequate renal function as
defined by a serum creatinine < 2. 0 x upper limit of normal.
- Patients must have received at least two previous chemotherapy regimens for their
disease.
- Patients must have measurable disease (NHL) or evaluable disease (myeloma, CLL).
Exclusion Criteria:
- Patients with symptomatic brain metastases are excluded from this study.
- Pregnant women or nursing mothers are not eligible for this trial. Patients of child
bearing potential must use adequate contraception.
- Patients may receive no other concurrent chemotherapy or radiation therapy during
this trial.
- Patients with severe medical problems such as uncontrolled diabetes mellitus or
cardiovascular disease or active infections are not eligible for this trial.
Locations and Contacts
Leanne Gideon, Phone: 505-272-5688, Email: lgideon@salud.unm.edu
University of New Mexico, Albuquerque, New Mexico 87131, United States; Recruiting
Leanne Gideon, Phone: 505-272-5688, Email: lgideon@salud.unm.edu
Robert Hromas, MD, Principal Investigator
Additional Information
Starting date: October 2004
Ending date: December 2009
Last updated: July 24, 2009
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