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

This study has been terminated.
(Low rate of accrual)
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00250718
First received: November 4, 2005
Last updated: July 3, 2014
Last verified: July 2014
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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:


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 ]

Enrollment: 17
Study Start Date: October 2004
Study Completion Date: May 2014
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Combination Tx
Treatment with combination therapy as follows: VP 50mg/d POx 14 days q 28 days Chlorambucil 0.1mg/kg/d POx 14 days q 28 days Vincristine 2mgIV 1 14 days Dexamethasone 200mg IV q 24 days Rituxan 375 mg/m3 IVI 1 14 days Levoflaxacin 500 mg PO qd Diflucan 200 mg PO qd
Drug: Vincristine
Vincristine should be administered intravenously through a freely-running IV. It will be administered 2mg IV q 14 days.
Other Name: Oncovin
Drug: VP-16
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
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.
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional 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: July 3, 2014
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:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Angiogenesis Inhibitors
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Levofloxacin
Ofloxacin
Rituximab
Vincristine
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Anti-Inflammatory Agents
Antiemetics
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Autonomic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2014