Rituximab and Interleukin-2 in Treating Patients With Relapsed or Refractory Intermediate- or High-Grade Non-Hodgkin's Lymphoma

NCT ID: NCT00059904

Last Updated: 2013-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2004-06-30

Brief Summary

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining rituximab with interleukin-2 may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining rituximab with interleukin-2 in treating patients who have relapsed or refractory intermediate- or high-grade non-Hodgkin's lymphoma.

Detailed Description

OBJECTIVES:

• Determine the clinical efficacy of rituximab and interleukin-2 in patients with relapsed or refractory intermediate- or high-grade non-Hodgkin's lymphoma.
• Determine the 2-year progression-free survival of patients treated with this regimen.
• Determine the safety of this regimen in these patients.
• Correlate response with natural killer cell numbers and rituximab, interleukin-2 (IL-2), and soluble IL-2 receptor levels in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive rituximab IV once weekly on weeks 1-4 and interleukin-2 subcutaneously 3 times weekly on weeks 2-9. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 12 weeks for 2 years.

PROJECTED ACCRUAL: A total of 50-100 patients will be accrued for this study.

Conditions

Lymphoma

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

aldesleukin

Intervention Type: BIOLOGICAL

rituximab

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of intermediate- or high-grade non-Hodgkin's lymphoma according to the Working Formulation, including the following subtypes:

• Diffuse large cell lymphoma
• Diffuse mixed cell lymphoma
• Immunoblastic large cell lymphoma
• CD20+ disease
• Measurable progressive or refractory disease
• No primary CNS lymphoma or lymphomatous meningitis NOTE: 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 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Lymphocyte count less than 20,000/mm^3
• Absolute neutrophil count at least 1,000/mm^3
• Platelet count at least 75,000/mm^3
• Hemoglobin at least 9.5 g/dL

Hepatic

• SGOT and SGPT no greater than 1.5 times upper limit of normal
• Bilirubin normal
• No liver disease
• Hepatitis C-seropositive patients are allowed provided they have no active disease, as demonstrated by any of the following:

• Undetectable hepatitis C viral loads
• Biopsy showing no active disease
• Normal transaminases on at least 3 different occasions within the past year

Renal

• Creatinine normal

Cardiovascular

• No clinically significant cardiac dysfunction
• No myocardial infarction within the past 6 months
• No heart failure within the past 6 months

Pulmonary

• No clinically significant pulmonary dysfunction
• Patients with prior radiotherapy to the lung or autologous transplantation must have FEV greater than 50% and DLCO greater than 50% within 8 weeks before study treatment

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• No significant infections within the past 2 weeks (including pneumonia or bronchitis)
• No history of autoimmune disease
• No prior or concurrent malignancy except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, or other solid tumor curatively treated with no evidence of recurrence within the past 2 years
• No symptomatic thyroid disease requiring medical intervention other than replacement treatment for hypothyroidism
• No prior type 1 hypersensitivity or anaphylactic reactions to murine products, rituximab, or radioimmunoconjugated anti-CD20 antibody infusion

PRIOR CONCURRENT THERAPY:

Biologic therapy

• At least 3 months since prior autologous bone marrow transplantation
• No prior allogeneic bone marrow transplantation
• No prior interleukin-2
• No prior interferon (alfa, beta, or gamma)
• No concurrent basiliximab, daclizumab, or monoclonal antibody OKT3

Chemotherapy

• More than 30 days since prior chemotherapy
• No concurrent anticancer chemotherapy

Endocrine therapy

• More than 2 weeks since prior systemic steroids
• No concurrent systemic corticosteroids

Radiotherapy

• More than 30 days since prior radiotherapy
• No concurrent radiotherapy

Surgery

• More than 30 days since prior major surgery

Other

• More than 30 days since other prior investigational drugs
• More than 30 days since prior immunosuppressive medications
• No concurrent immunosuppressive medications including the following:

• Cyclosporine
• Mycophenolate mofetil
• Tacrolimus
• Sirolimus

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Tarun Kewalramani, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

MSKCC-03004

Identifier Type: -

Identifier Source: secondary_id

CDR0000298986

Identifier Type: REGISTRY

Identifier Source: secondary_id

CHIR-IL2005-A01

Identifier Type: -

Identifier Source: org_study_id