AzTrials
AzTrials

LymphomaPhase 2NCT00002501

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

A Phase 2 study testing filgrastim and cyclophosphamide in people with Lymphoma, run by Alliance for Clinical Trials in Oncology at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Lymphoma
What is being tested?
filgrastim and cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
15 sitesUnited States
Study dates
Oct 1992to Jan 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

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

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites
  • Marlene & Stewart Greenebaum Cancer Center, University of Maryland

    Baltimore, Maryland, 21201

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637

  • Ellis Fischel Cancer Center - Columbia

    Columbia, Missouri, 65203

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • University of Tennessee, Memphis Cancer Center

    Memphis, Tennessee, 38103

  • Mount Sinai Medical Center, NY

    New York, New York, 10029

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • State University of New York - Upstate Medical University

    Syracuse, New York, 13210

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina, 27104-4241

  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157-1082

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Lymphoma
Keywords
stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma
Medical subject headings
Lymphoma, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00002501
Study groupRoleWhat they receive
cyclophosphamide + filgrastimExperimentalPatients 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.
Receives: Biological: filgrastim; Drug: cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Toxicity

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2004 (estimated)
  2. Study startOct 1992
  3. Primary completionJul 2001
  4. Study completionJan 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002501
Sponsor's protocol ID
CALGB-9150
Other IDs
CLB-9150, CDR0000077861
Status last verified
Jun 2016
First submitted
1 Nov 1999
Last updated
1 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • Lichtman SM, Petroni G, Schilsky RL, Johnson JL, Perri RT, Niedzwiecki D, Sklar J, Barcos M, Peterson BA. High dose cyclophosphamide plus recombinant human granulocyte-colony stimulating factor (rhG-CSF) in the treatment of follicular, low grade non-Hodgkin's lymphoma: CALGB 9150. Leuk Lymphoma. 2001 Nov-Dec;42(6):1255-64. doi: 10.3109/10428190109097750.

    PubMed 11911406

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing filgrastim and cyclophosphamide in people with Lymphoma, run by Alliance for Clinical Trials in Oncology at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Toxicity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002501, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2016.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in