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

Sponsor:	New Mexico Cancer Care Alliance
Information provided by (Responsible Party):	New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:	NCT00250718

Purpose

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	Intervention	Phase
Non-Hodgkin's Lymphoma Cancer	Drug: Vincristine Drug: VP-16 Drug: Rituximab Drug: Dexamethasone Drug: Levofloxacin	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Study: Treatment of Relapsed Lymphoid Malignancies With an Anti-angiogenic Approach

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Dexamethasone Vincristine Etoposide Dexamethasone acetate Doxiproct plus Ofloxacin Levofloxacin Etoposide phosphate Ofloxacin hydrochloride Rituximab Dexamethasone Sodium Phosphate Vincristine sulfate

U.S. FDA Resources

Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:

Either complete or partial remission, or stabilization of disease pending complete recovery of non hematologic toxicity (aside from alopecia), with return of blood cell counts to > 1000 granulocytes and > 50,000 platelets. [ Time Frame: Progressive disease during therapy after 2 cycles. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Toxicity will be evaluated at each course of therapy. [ Time Frame: end of 2 cycles (cycle = 28 days) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	35
Study Start Date:	October 2004
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Vincristine should be administered intravenously through a freely-running IV. It will be administered 2mg IV q 14 days.

Other Name: Oncovin

The VP-16 is optional for the first cycle if the patient has delays in obtaining the drug. Dose and schedule 50 mg/d P.O. x 14 days q 28 days.

Other Names:

(Etoposide)(Vepesid)(Ethylidene-Lignan P
NSC-67574

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.

Other Name: Rituxan

Dexamethasone will be administered at 200mg q 14 days. Dexamethasone should be administered over a 1 hour infusion.

Other Name: decadron

Levofloxacin will be administered at 500 mg PO qd.

Other Names:

Levaquin
Levaquin Leva-Pak

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All patients, 18 years of age or older, with Hodgkin's lymphoma, NHL, myeloma, or 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 (myeloma, 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250718

Locations

United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131

Sponsors and Collaborators

New Mexico Cancer Care Alliance

Investigators

Principal Investigator:	K K Rasila, MD	UNM Cancer Center
Study Chair:	Robert Hromas, MD	UNM Cancer Center

More Information

No publications provided

Responsible Party:	New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:	NCT00250718 History of Changes
Other Study ID Numbers:	INST 1003C
Study First Received:	November 4, 2005
Last Updated:	August 30, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by New Mexico Cancer Care Alliance:

Non Hodgkin's Lymphoma
Phase II
Lymphoid malignancies

Additional relevant MeSH terms:

Neoplasms
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Rituximab
Etoposide
Vincristine
BB 1101

Ofloxacin
Angiogenesis Inhibitors
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on February 09, 2012