Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI, Pharmaceutical / Industry	MSKCC-03004 CHIR-IL2005-A01, NCT00059904

Objectives

1. Determine the clinical efficacy of rituximab and interleukin-2 in patients with relapsed or refractory intermediate- or high-grade non-Hodgkin's lymphoma.
2. Determine the 2-year progression-free survival of patients treated with this regimen.
3. Determine the safety of this regimen in these patients.
4. 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.

Entry 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.]

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Lymphocyte count less than 20,000/mm³
• Absolute neutrophil count at least 1,000/mm³
• Platelet count at least 75,000/mm³
• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Tarun Kewalramani, MD, Protocol chair		Ph: 212-639-3069; 800-525-2225

Registry Information
Official Title		An Open-Labeled, Phase II Study of Rituximab in Combination with Recombinant IL-2 for Relapsed or Refractory Non-Hodgkin's Lymphoma of Intermediate- or High-Grade Histology
Trial Start Date		2003-01-14
Registered in ClinicalTrials.gov		NCT00059904
Date Submitted to PDQ		2003-03-12
Information Last Verified		2004-07-08
NCI Grant/Contract Number		P30-CA08748

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