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

July 6, 2015 updated by: New Mexico Cancer Care Alliance

Phase II 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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 Combination Treatment

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
Drug: Vincristine
Vincristine should be administered intravenously through a freely-running IV.
Other Names:
  • Oncovin
Drug: VP-16
The VP-16 is optional for the first cycle if the patient has delays in obtaining the drug.
Other Names:
  • Vepesid
  • Etoposide
  • NSC-67574
  • Ethylidene-Lignan P
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

Other Names:
  • Rituxan
Drug: Dexamethasone
Dexamethasone will be administered at 200mg q 14 days. Dexamethasone should be administered over a 1 hour infusion.
Other Names:
  • decadron
Drug: Levofloxacin
Levofloxacin will be administered at 500 mg PO qd.
Other Names:
  • Levaquin
  • Levaquin Leva-Pak

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR), the Sum of Complete and Partial Responses
Time Frame: Up to 6 months after first on-study treatment

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.
Up to 6 months after first on-study treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity
Time Frame: End of 2 cycles (cycle = 28 days)
End of 2 cycles (cycle = 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New Mexico Cancer Care Alliance

Investigators

  • Principal Investigator: Dulcinea Quintana, MD, UNM Cancer Center
  • Study Chair: Robert Hromas, MD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

November 4, 2005

First Submitted That Met QC Criteria

November 4, 2005

First Posted (Estimate)

November 8, 2005

Study Record Updates

Last Update Posted (Estimate)

August 3, 2015

Last Update Submitted That Met QC Criteria

July 6, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INST 1003C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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