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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00250718
Recruitment Status : Terminated (Low rate of accrual)
First Posted : November 8, 2005
Results First Posted : August 3, 2015
Last Update Posted : August 3, 2015
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance

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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Cancer Drug: Vincristine Drug: VP-16 Drug: Rituximab Drug: Dexamethasone Drug: Levofloxacin Phase 2

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  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study: Treatment of Relapsed Lymphoid Malignancies With an Anti-angiogenic Approach
Study Start Date : October 2004
Actual Primary Completion Date : November 2008
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

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 Name: Oncovin

Drug: VP-16
The VP-16 is optional for the first cycle if the patient has delays in obtaining the drug.
Other Names:
  • Etoposide
  • NSC-67574
  • Vepesid
  • 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 Name: Rituxan

Drug: Dexamethasone
Dexamethasone will be administered at 200mg q 14 days. Dexamethasone should be administered over a 1 hour infusion.
Other Name: decadron

Drug: Levofloxacin
Levofloxacin will be administered at 500 mg PO qd.
Other Names:
  • Levaquin
  • Levaquin Leva-Pak

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: End of 2 cycles (cycle = 28 days) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00250718

United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Principal Investigator: Dulcinea Quintana, MD UNM Cancer Center
Study Chair: Robert Hromas, MD University of Florida

Additional Information:
Responsible Party: New Mexico Cancer Care Alliance Identifier: NCT00250718     History of Changes
Other Study ID Numbers: INST 1003C
First Posted: November 8, 2005    Key Record Dates
Results First Posted: August 3, 2015
Last Update Posted: August 3, 2015
Last Verified: July 2015

Keywords provided by New Mexico Cancer Care Alliance:
Non Hodgkin's Lymphoma
Phase II
Lymphoid malignancies

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
BB 1101
Angiogenesis Inhibitors
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors