Cyclophosphamide and Filgrastim in Treating Patients With Stage IV, Relapsed, or Refractory Low-Grade Follicular Non-Hodgkin's Lymphoma

June 30, 2016 updated by: Alliance for Clinical Trials in Oncology

PHASE II STUDY OF HIGH-DOSE CYCLOPHOSPHAMIDE PLUS RECOMBINANT HUMAN GRANULOCYTE-COLONY STIMULATING FACTOR (rhG-CSF) IN THE TREATMENT OF FOLLICULAR LOW-GRADE NON-HODGKIN'S LYMPHOMA

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of cyclophosphamide and filgrastim in treating patients with stage IV, relapsed, or refractory low-grade follicular non-Hodgkin's lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the feasibility of high-dose cyclophosphamide and filgrastim (G-CSF) in patients with stage IV, relapsed, or progressive low-grade follicular non-Hodgkin's lymphoma. II. Determine the toxic effects of this regimen in these patients, including those with marrow involvement. III. Determine the rates of complete remission (CR) and partial remission and time to failure in previously treated and untreated patients. IV. Determine the effectiveness of this regimen in eradicating bcl-2 rearrangements, as determined by polymerase chain reaction (PCR), in previously untreated patients. V. Correlate the duration of CR to PCR results in responding patients.

OUTLINE: Patients are stratified according to prior treatment (yes vs no). Patients receive cyclophosphamide IV over 90 minutes on day 1 and filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing until blood counts recover. Treatment continues every 2 weeks for 4 courses in the absence of disease progression or stable disease. Patients who achieve complete remission (CR) after completion of course 4 receive 2 additional courses. Patients who achieve partial remission (PR) after completion of course 4 receive 2 additional courses, and those who achieve CR after completion of course 6 receive 2 additional courses. Patients are followed every 2 months for 6 months, every 6 months for 2 years, and then annually thereafter.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Cancer Research Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Marlene & Stewart Greenebaum Cancer Center, University of Maryland
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Memorial Medical Center
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Ellis Fischel Cancer Center - Columbia
      • Saint Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • CCOP - Southern Nevada Cancer Research Foundation
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Norris Cotton Cancer Center
    • New York
      • Manhasset, New York, United States, 11030
        • CCOP - North Shore University Hospital
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center, NY
      • Syracuse, New York, United States, 13210
        • State University of New York - Upstate Medical University
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27104-4241
        • CCOP - Southeast Cancer Control Consortium
      • Winston-Salem, North Carolina, United States, 27157-1082
        • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • University of Tennessee, Memphis Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically proven low-grade non-Hodgkin's lymphoma of the following subtypes: Follicular, predominantly small cleaved cell Follicular mixed (small cleaved and large cell) Previously treated on Protocol CLB 8691 or previously untreated Previously untreated patients with Stage IV disease (Ann Arbor classification) must meet the following conditions: Documented bone marrow involvement Lymph node biopsy must not show higher grade lymphoma At least 1 additional risk factor as follows: At least 2 extranodal sites Nodes or nodal group at least 5 cm Male Previously treated patients must have progressed or relapsed on Protocol CLB-8691 Recurrence should be documented by biopsy if possible Bidimensionally measurable disease by physical exam, radiograph, CT, or MRI (sonography and barium studies alone not acceptable) Measurable liver disease defined as: Mass greater than 3.5 cm on CT, MRI, or ultrasound OR Histologically documented lymphomatous hepatomegaly more than 5 cm below the costal margin The following disease manifestations are not considered measurable: Ascites or pleural effusion Bony disease (lytic lesions on x-ray should be documented and followed) CNS lesions Bone marrow involvement No lymphomatous involvement (including CNS lymphoma) requiring immediate radiotherapy A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS: Age: 18 to physiologic 55 Patients over 55 are eligible only if study chairperson agrees that the patient can tolerate intensive chemotherapy Performance status: Zubrod 0-1 Life expectancy: More than 2 years Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin less than 1.5 times normal Renal: Creatinine less than 1.5 times normal Cardiovascular: LVEF at least 50% No acute changes or arrhythmias on ECG No cardiomegaly on chest x-ray or physical exam No uncontrolled or severe cardiovascular disease, including myocardial infarction within the past 6 months or congestive heart failure (CHF) No active cardiac problems, including compensated CHF or angina Other: HIV negative No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix No active uncontrolled bacterial, viral, or fungal infection No other serious medical illness that would limit survival to less than 2 years No psychiatric condition that would preclude informed consent or compliance No uncontrolled duodenal ulcer Not pregnant Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior interferon only on Protocol CLB-8691 allowed Chemotherapy: Prior oral cyclophosphamide only on Protocol CLB-8691 allowed No concurrent chemotherapy Endocrine therapy: No chronic steroids for other health problems No concurrent steroids for any condition including documented CNS metastases, adrenal failure, or septic shock Nonsteroidal hormonal drugs for nondisease related problems allowed (e.g., insulin for diabetes) Radiotherapy: See Disease Characteristics No prior radiotherapy No concurrent palliative radiotherapy Surgery: At least 2 weeks since prior major surgery Other: No other prior therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: cyclophosphamide + filgrastim
Patients receive cyclophosphamide IV over 90 minutes on day 1 and filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing until blood counts recover. Treatment continues every 2 weeks for 4 courses in the absence of disease progression or stable disease. Patients who achieve complete remission (CR) after completion of course 4 receive 2 additional courses. Patients who achieve partial remission (PR) after completion of course 4 receive 2 additional courses, and those who achieve CR after completion of course 6 receive 2 additional courses. Patients are followed every 2 months for 6 months, every 6 months for 2 years, and then annually thereafter.
Drug: cyclophosphamide
Biological: filgrastim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Toxicity
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Robert Perri, MD, Veterans Affairs Medical Center - Minneapolis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1992

Primary Completion (ACTUAL)

July 1, 2001

Study Completion (ACTUAL)

January 1, 2006

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

April 21, 2004

First Posted (ESTIMATE)

April 22, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

July 1, 2016

Last Update Submitted That Met QC Criteria

June 30, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALGB-9150
  • CLB-9150
  • CDR0000077861 (REGISTRY: NCI Physician Data Query)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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