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Recurrent Adult Burkitt LymphomaPhase 3NCT00002649

Interleukin-2 or Observation Following Radiation Therapy, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Non-Hodgkin's Lymphoma

A Phase 3 study testing aldesleukin, filgrastim and cyclophosphamide in people with Recurrent Adult Burkitt Lymphoma and Recurrent Adult Diffuse Large Cell Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

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

Official record
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Trial summary

Randomized phase III trial to compare the effectiveness of interleukin-2 with that of observation following radiation therapy, combination chemotherapy, and peripheral stem cell transplantation in treating patients who have refractory or relapsed non-Hodgkin's lymphoma. Read more about this study

Who is it for?
Ages 16 to 60 years
What is being tested?
aldesleukin, filgrastim and cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
206 participants
Where
1 siteUnited States
Study dates
May 1995to Nov 2006
Phase
Phase 3
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 16 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • REGISTRATION # 1
  • All patients must have biopsy proven diagnosis of low, intermediate or high grade malignant non-Hodgkin's lymphoma; transformed lymphomas are eligible
  • Patients with histologic diagnosis of working formulation A (malignant lymphoma small lymphocytic) or working formulation I (malignant lymphoma, lymphoblastic) are not eligible
  • Patients must have relapsed after achieving a complete or partial response to prior therapy, or have never responded to prior therapy
  • Patients must have debulking (salvage) chemotherapy to determine if the disease is sensitive to chemotherapy; the sole exception to this requirement is for patients with intermediate or high grade lymphoma (working formulation D - H or J) whose disease did not respond to, or progressed during, INITIAL chemotherapy
  • Prior therapy is required; concurrent therapy is NOT permitted
Show all 46Show fewer
  • Patients with low grade lymphoma (working formulation B or C) must have received at least two prior chemotherapy regimens; if the patient has had one or more CR, then the most recent CR must have been less than one year in duration
  • Patients with intermediate or high grade non-Hodgkin's lymphoma (working formulation D - H or J) must have received at least one prior chemotherapy regimen
  • NOTE: Debulking chemotherapy given only to determine sensitivity is not considered in the calculation of number of prior regimens
  • Patients must have a bone marrow aspirate and biopsy obtained within 42 days of stem cell collection or within 42 days prior to registration
  • Patients with a history of seizures or central nervous system involvement by lymphoma are NOT eligible
  • Only patients with a normal cardiac history and physical exam or in lieu of this, an institutionally normal ejection fraction as measured by either ECHO or MUGA scan are eligible; specifically, there should be: no EKG evidence of active cardiac disease (i.e., arrhythmias, ischemia), no history of congestive heart failure (CHF), no history of myocardial infarction or ischemia, no history of arrhythmia (other than bradycardia treated by pacing), no current cardiac medications for the control of CHF or arrhythmias, no S3 gallop rhythm, or peripheral edema, and no chest X-ray findings compatible with CHF; EKG must be performed within 42 days prior to registration
  • All patients must have a pretreatment serum creatinine of =< 1.5 times the institutional upper limit of normal measured after completion of prior therapy and within 28 days prior to registration
  • Patients must have adequate pulmonary function as measured by a DLCO >= 65% of predicted or FEV1 >= 65% of predicted measured after completion of prior therapy and within 120 days prior to registration
  • Patients must have adequate hepatic function as measured by a bilirubin of =< 1.5 x the institutional upper limit of normal and SGOT or SGPT =< 2 x the institutional upper limit of normal, measured after completion of prior therapy and within 28 days prior to registration
  • Patients who have undergone previous bone marrow transplantation or autologous peripheral blood stem cell transplantation are NOT eligible
  • Patients who have undergone previous therapy with interleukin-2 are NOT eligible
  • Patients must have recovered from the nadir resulting from the last cancer therapy; this will generally be at least four weeks from prior radiation or chemotherapy, and six weeks from nitrosoureas
  • Patients must have a Southwest Oncology Group performance status of 0 or 1
  • Patients must have a CT scan of the chest, abdomen and pelvis performed within 28 days prior to registration and at least 21 days after the completion of prior chemotherapy (excluding mobilization therapy)
  • Patients must have LDH performed within 28 days prior to registration and at least 21 days after completion of prior chemotherapy (excluding mobilization therapy)
  • Patients must have undergone an adequate collection of peripheral blood stem cells (PBSC) according to accepted procedures at each individual institution
  • Patients with known allergy to etoposide or a history of grade 3 hemorrhagic cystitis with cyclophosphamide are not eligible
  • Patients who have received prior involved field irradiation prohibiting the use of TBI are not eligible
  • Patients must be negative for antibody to HIV and this test must have been performed within 42 days prior to registration; patients must not have an autoimmune disease or have had a prior allogeneic (from someone else) organ or tissue transplant
  • If day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day; in calculating days of tests and measurements, the day a test or measurement is done is considered day 0; therefore, if a test is done on a Monday, the Monday four weeks later would be considered day 28; this allows for efficient patient scheduling without exceeding the guidelines
  • No prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years
  • Pregnant or nursing women may not participate; women or men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • At the time of patient registration, the treating institution's name and ID number must be provided to the statistical center in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the database
  • REGISTRATION # 2 (RANDOMIZATION)
  • Patients who are less than 28 days or more than 80 days after PBSCT will not be registered for randomization
  • Patients known to be ineligible for registration step #1 may not be registered to registration step #2
  • Restaging radiographic studies are not required between PBSCT and registration #2 (randomization), however, patients with known active recurrent or progressive disease are not eligible for randomization
  • ANC > 500 mm^3
  • Platelet count supportable to > 20,000/mm^3 with no more than one transfusion per day
  • The patient must be free of active bacterial, fungal or viral infection, afebrile, off antibiotics, antifungal and antiviral agents (with the exception of prophylactic therapy) for three consecutive days
  • Bilirubin =< 2 times the institutional upper limit of normal; test must be completed within 7 days prior to registration
  • SGOT or SGPT =< 2 times the institutional upper limit of normal; test must be completed within 7 days prior to registration
  • Alkaline phosphatase =< 2 times the institutional upper limit of normal; test must be completed within 7 days prior to registration
  • Creatinine =< 1.5 times the institutional upper limit of normal; test must be completed within 7 days prior to registration
  • The patient must have =< grade 1 cardiac, pulmonary, CNS, renal, hepatic, GI toxicity and < grade 3 mucosal toxicity according to the Southwest Oncology Group Toxicity Criteria
  • The patient must have received no amphotericin B, corticosteroids, pentoxifylline, or growth factors for at least 72 hours prior to registration
  • The patient must have a current Southwest Oncology Group performance status of 0-2
  • Patients must have an EKG with no active cardiac disease and a chest x-ray with no active pulmonary disease; these tests must be completed within 7 days prior to registration
  • Patients must not have an autoimmune disease or have had a prior allogeneic (from someone else) organ or tissue transplant

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Southwest Oncology Group

    San Antonio, Texas, 78245

Other trials in United States

About this study

Official title: Total Body Irradiation, Etoposide, Cyclophosphamide and Autologous Peripheral Blood Stem Cell Transplantation Followed by Randomization to Therapy With Interleukin-2 Versus Observation for Patients With Non-Hodgkin's Lymphoma

Randomized phase III trial to compare the effectiveness of interleukin-2 with that of observation following radiation therapy, combination chemotherapy, and peripheral stem cell transplantation in treating patients who have refractory or relapsed non-Hodgkin's lymphoma. Interleukin-2 may stimulate a person's white blood cells to kill non-Hodgkin's lymphoma cells. Giving interleukin-2 after radiation therapy, chemotherapy, and peripheral stem cell transplantation may kill more cancer cells

Read the detailed description

PRIMARY OBJECTIVES:

  1. To compare the survival and disease-free survival of patients with non-Hodgkin's lymphoma treated with post-transplant therapy with interleukin-2 (IL-2) or no further treatment. Transplant therapy is total body irradiation (TBI), high-dose etoposide, cyclophosphamide and peripheral blood stem cell transplant (PBSCT).

II. To assess the frequency and severity of toxicity associated with post-transplant IL-2 therapy.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease grade (low vs intermediate vs high), chemosensitive disease (yes vs no), partial or complete response after initial induction chemotherapy (yes vs no), and performance status (0-1 vs 2).

Part I: Autologous peripheral blood stem cells (PBSC) are harvested before study entry. Patients undergo total body irradiation twice a day on days -8 to -5, high-dose etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 1 hour on day -2. PBSC are reinfused on day 0 and then filgrastim (G-CSF) may be administered subcutaneously or IV on days 0-21.

Part II: Within 28-80 days after PBSC transplantation and after recovery from any toxic effects, patients with no active recurrent or progressive disease are randomized to 1 of 2 treatment arms.

Arm I: Patients receive interleukin-2 IV continuously on days 1-4 and 9-18.

Arm II: Patients undergo observation only.

Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 275 patients will be accrued for this study within 3.5-5.9 years.

Being tested
aldesleukin, filgrastim, cyclophosphamide, etoposide, radiation therapy
Medical subject headings
Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Immunoblastic, Lymphoma, Follicular

What participants receive

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

  • aldesleukinBiological

    Also called IL-2, Proleukin, recombinant human interleukin-2, recombinant interleukin-2

    Given IV

  • filgrastimBiological

    Also called G-CSF, Neupogen

    Given SC or IV

  • cyclophosphamideDrug

    Also called CPM, CTX, Cytoxan, Endoxan

    Given IV

  • etoposideDrug

    Also called EPEG, VP-16, VP-16-213

    Given IV

  • radiation therapyRadiation

    Also called irradiation, radiotherapy, therapy, radiation

    Undergo radiation therapy

  • peripheral blood stem cell transplantationProcedure or surgery

    Also called PBPC transplantation, PBSC transplantation, peripheral blood progenitor cell transplantation, transplantation, peripheral blood stem cell

    Undergo autologous peripheral blood stem cell transplant

  • bone marrow ablation with stem cell supportProcedure or surgery

    Undergo bone marrow ablation with stem cell support

Study groups in NCT00002649
Study groupRoleWhat they receive
Arm I (autologous PBSCT, TBI, etoposide, cyclophosphamide)ExperimentalPart I: Autologous PBSC are harvested before study entry. Patients undergo total body irradiation twice a day on days -8 to -5, high-dose etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 1 hour on day -2. PBSC are reinfused on day 0 and then G-CSF may be administered subcutaneously or IV on days 0-21. Part II: Within 28-80 days after PBSC transplantation and after recovery from any toxic effects, patients with no active recurrent or progressive disease are randomized to 1 of 2 treatment arms. Patients receive interleukin-2 IV continuously on days 1-4 and 9-18.
Receives: Biological: aldesleukin; Biological: filgrastim; Drug: cyclophosphamide; Drug: etoposide; Radiation: radiation therapy; Procedure: peripheral blood stem cell transplantation; Procedure: bone marrow ablation with stem cell support
Arm II (observation only)No interventionPatients undergo observation only.

What is being measured

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

  1. Overall survival

    Measured: Up to 13 years

  2. Disease-free survival

    Measured: Up to 13 years

  3. Frequency and severity of toxicity associated with post-transplant aldesleukin therapy

    Measured: Up to 13 years

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startMay 1995
  3. Primary completionNov 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002649
Sponsor's protocol ID
NCI-2012-03072
Other IDs
SWOG-9438, U10CA032102, CDR0000064175
Status last verified
Feb 2013
First submitted
1 Nov 1999
Last updated
28 Feb 2013
Results posted
No

Publications

  • Thompson JA, Fisher RI, Leblanc M, Forman SJ, Press OW, Unger JM, Nademanee AP, Stiff PJ, Petersdorf SH, Fefer A. Total body irradiation, etoposide, cyclophosphamide, and autologous peripheral blood stem-cell transplantation followed by randomization to therapy with interleukin-2 versus observation for patients with non-Hodgkin lymphoma: results of a phase 3 randomized trial by the Southwest Oncology Group (SWOG 9438). Blood. 2008 Apr 15;111(8):4048-54. doi: 10.1182/blood-2007-09-111708. Epub 2008 Feb 6.

    PubMed 18256325

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing aldesleukin, filgrastim and cyclophosphamide in people with Recurrent Adult Burkitt Lymphoma and Recurrent Adult Diffuse Large Cell Lymphoma, run by National Cancer Institute (NCI) at 1 site 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?

The sponsor lists 46 inclusion and 0 exclusion criteria. 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 28 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Overall survival (time frame: Up to 13 years). The study lists 3 primary outcomes in all. 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 NCT00002649, 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 28 Feb 2013; AzTrials last refreshed its copy on 7 Nov 2026.

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