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

Completed · Phase 3

Conditions studied: Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma

In brief

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

Key facts

Study ID

NCT00002649

Run by

National Cancer Institute (NCI)

People needed

206

Starts

1995-05-01

Last updated by the study team

2013-02-28

Who can join

Age: 16 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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

Where it is running

• Southwest Oncology Group — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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