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

New Mexico Cancer Care Alliance

Status and phase: Terminated; Phase 2

Conditions: Non-Hodgkin's Lymphoma; Cancer

Treatments: Drug: Dexamethasone; Drug: Rituximab; Drug: VP-16; Drug: Vincristine; Drug: Levofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT00250718

INST 1003C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Arm 1 Combination Treatment

Experimental group

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

Treatment:

Drug: Levofloxacin

Drug: VP-16

Drug: Vincristine

Drug: Rituximab

Drug: Dexamethasone