Study: Treatment of Relapsed Lymphoid Malignancies With an Anti-Angiogenic Approach
Condition: Non-Hodgkin's Lymphoma; Cancer
MeSH terms: Neoplasms; Lymphoma, Non-Hodgkin
Intervention: Vincristine; VP-16; Rituximab; Dexamethasone; Levofloxacin
Intervention description: Vincristine should be administered intravenously through a freely-running IV.; The VP-16 is optional for the first cycle if the patient has delays in obtaining the drug.; 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; Dexamethasone will be administered at 200mg q 14 days. Dexamethasone should be administered over a 1 hour infusion.; Levofloxacin will be administered at 500 mg PO qd.
Intervention MeSH terms: Levofloxacin; Ofloxacin; Dexamethasone; Rituximab; Etoposide; Vincristine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non Hodgkin's Lymphoma; Phase II; Lymphoid malignancies

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.
    

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.