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

Primary Purpose

Non-Hodgkin's Lymphoma, Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vincristine
VP-16
Rituximab
Dexamethasone
Levofloxacin
Sponsored by
New Mexico Cancer Care Alliance
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring Non Hodgkin's Lymphoma, Phase II, Lymphoid malignancies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All patients, 18 years of age or older, with Hodgkin's lymphoma, Non-Hodgkin lymphoma (NHL), multiple myeloma (MM), or chronic lymphocytic leukemia (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 (MM, 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.

Sites / Locations

  • University of New Mexico Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1 Combination Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR), the Sum of Complete and Partial Responses
Solid tumor response is per Response Evaluation Criteria in Solid Tumors (RECIST) (ver 1.0). For CLL: complete remission (CR) requires the following for>=2 months 1) no symptoms attributable to CLL, 2) normal physical examination, 3) absolute lymphocyte count<4,000/µL, 4) ANC>1,500/µL, 5) platelets>100,000/µL, 6) hemoglobin>11 g/dL, 7) bone marrow lymphocytosis<30%, 8) no nodules in bone marrow. Partial response (PR) requires the following for >=2 months 1) decrease in previously enlarged nodes, spleen, and liver by >=50%, 2) ANC>=1,500/µL or platelets>=100,000/µL, 3) hemoglobin>=11 g/dL, 4) 50% improvement over pre-therapy reductions in hemoglobin and/or platelets. For MM, CR is no monoclonal protein (M-protein) in blood and urine and <5% plasma cells in bone marrow on >=2 determinations >=6 wk apart & stable bone disease & calcium levels. PR is>50% and >90% decreases in serum & urine M-protein, respectively, on >=2 occasions for >=6 wk, stable bone disease & calcium.

Secondary Outcome Measures

Toxicity

Full Information

First Posted
November 4, 2005
Last Updated
July 6, 2015
Sponsor
New Mexico Cancer Care Alliance
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1. Study Identification

Unique Protocol Identification Number
NCT00250718
Brief Title
Study: Treatment of Relapsed Lymphoid Malignancies With an Anti-Angiogenic Approach
Official Title
Phase II Study: Treatment of Relapsed Lymphoid Malignancies With an Anti-angiogenic Approach
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
Low rate of accrual
Study Start Date
October 2004 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New Mexico Cancer Care Alliance

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma, Cancer
Keywords
Non Hodgkin's Lymphoma, Phase II, Lymphoid malignancies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 Combination Treatment
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Vincristine
Other Intervention Name(s)
Oncovin
Intervention Description
Vincristine should be administered intravenously through a freely-running IV.
Intervention Type
Drug
Intervention Name(s)
VP-16
Other Intervention Name(s)
Etoposide, NSC-67574, Vepesid, Ethylidene-Lignan P
Intervention Description
The VP-16 is optional for the first cycle if the patient has delays in obtaining the drug.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan
Intervention Description
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 Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
decadron
Intervention Description
Dexamethasone will be administered at 200mg q 14 days. Dexamethasone should be administered over a 1 hour infusion.
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Other Intervention Name(s)
Levaquin, Levaquin Leva-Pak
Intervention Description
Levofloxacin will be administered at 500 mg PO qd.
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR), the Sum of Complete and Partial Responses
Description
Solid tumor response is per Response Evaluation Criteria in Solid Tumors (RECIST) (ver 1.0). For CLL: complete remission (CR) requires the following for>=2 months 1) no symptoms attributable to CLL, 2) normal physical examination, 3) absolute lymphocyte count<4,000/µL, 4) ANC>1,500/µL, 5) platelets>100,000/µL, 6) hemoglobin>11 g/dL, 7) bone marrow lymphocytosis<30%, 8) no nodules in bone marrow. Partial response (PR) requires the following for >=2 months 1) decrease in previously enlarged nodes, spleen, and liver by >=50%, 2) ANC>=1,500/µL or platelets>=100,000/µL, 3) hemoglobin>=11 g/dL, 4) 50% improvement over pre-therapy reductions in hemoglobin and/or platelets. For MM, CR is no monoclonal protein (M-protein) in blood and urine and <5% plasma cells in bone marrow on >=2 determinations >=6 wk apart & stable bone disease & calcium levels. PR is>50% and >90% decreases in serum & urine M-protein, respectively, on >=2 occasions for >=6 wk, stable bone disease & calcium.
Time Frame
Up to 6 months after first on-study treatment
Secondary Outcome Measure Information:
Title
Toxicity
Time Frame
End of 2 cycles (cycle = 28 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients, 18 years of age or older, with Hodgkin's lymphoma, Non-Hodgkin lymphoma (NHL), multiple myeloma (MM), or chronic lymphocytic leukemia (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 (MM, 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dulcinea Quintana, MD
Organizational Affiliation
UNM Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Hromas, MD
Organizational Affiliation
University of Florida
Official's Role
Study Chair
Facility Information:
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.nmcca.org
Description
New Mexico Cancer Care Alliance
URL
http://www.cancer.unm.edu
Description
UNM Cancer Center

Learn more about this trial

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

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