Clinical trial NCT00250718: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Cancer
Keywords: Non Hodgkin's Lymphoma
Phase II
Lymphoid malignancies
Lead sponsor: New Mexico Cancer Research Alliance
Sponsor class: OTHER
First posted: 2005-11-08
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Overall Response Rate (ORR), the Sum of Complete and Partial Responses
timeFrame: Up to 6 months after first on-study treatment
Secondary outcomes:
measure: Toxicity
timeFrame: End of 2 cycles (cycle = 28 days)
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
Study officials:
affiliation: UNM Cancer Center
name: Dulcinea Quintana, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Robert Hromas, MD
role: STUDY_CHAIR
References: