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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00002501
First received: November 1, 1999
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Lymphoma
Biological: filgrastim
Drug: cyclophosphamide
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Toxicity [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 29
Study Start Date: October 1992
Study Completion Date: January 2006
Primary Completion Date: July 2001 (Final data collection date for primary outcome measure)
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.

PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  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: NCT00002501

Locations
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Maryland
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Missouri
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States, 65203
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756
United States, New York
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
Mount Sinai Medical Center, NY
New York, New York, United States, 10029
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157-1082
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Tennessee
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, United States, 38103
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Robert T. Perri, MD Veterans Affairs Medical Center - Minneapolis
  More Information

Additional Information:
Publications:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00002501     History of Changes
Other Study ID Numbers: CDR0000077861, CLB-9150
Study First Received: November 1, 1999
Last Updated: September 27, 2013
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Lenograstim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on July 22, 2014