Rituximab and Interleukin-12 in Treating Patients With B-Cell Non-Hodgkin's Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Brief Summary

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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-12 may kill cancer cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Combining rituximab with interleukin-12 may kill more cancer cells. This randomized phase II trial is comparing how well giving rituximab together with two different schedules of interleukin-12 works in treating patients with B-cell non-Hodgkin lymphoma.

Detailed Description

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OBJECTIVES:

I. Compare the objective response in patients with B-cell non-Hodgkin's lymphoma treated with rituximab and 2 different schedules of interleukin-12\*.

II. Compare the toxic effects of these regimens in these patients. III. Determine the objective response rate in patients with mantle cell lymphoma treated with these regimens.

IV. Determine the overall and progression-free survival of patients treated with these regimens.

V, Compare the quality of life of patients treated with these regimens. NOTE: \*Interleukin-12 will no longer be available after 6/30/05.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to histology (mantle cell lymphoma vs other \[closed to accrual as of 3/10/04\]) and International Prognostic Factor Index (low and low-intermediate risk \[closed to accrual as of 3/10/04\] vs high-intermediate and high risk). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive rituximab IV on days 1, 8, 15, and 22. Patients receive interleukin-12\* subcutaneously (SC) twice weekly beginning on day 2 and continuing until disease progression.

ARM II (closed to accrual as of 11/14/03): Patients receive rituximab as in arm I. Patients are evaluated at week 12. Patients with stable or progressive disease receive interleukin-12\* SC twice weekly until disease progression or for 24 weeks. Patients with a complete or partial response after rituximab are monitored until disease progression and then begin interleukin-12 SC twice weekly until further disease progression.

NOTE: \*Interleukin-12 will no longer be available after 06/30/05. Patients proceed to follow-up as outlined below.

Quality of life is assessed at baseline and at 3 and 6 months.

Patients are followed every 3 months for 1 year and then every 6 months for up to 4 years.

PROJECTED ACCRUAL: A total of 90 patients (45 per treatment arm \[arm II closed to accrual as of 11/14/03\]) will be accrued for this study within 3 years.

Conditions

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Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Nodal Marginal Zone B-cell Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Small Lymphocytic Lymphoma Splenic Marginal Zone Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I (rituximab and recombinant interleukin-12)

Patients receive rituximab IV on days 1, 8, 15, and 22. Patients receive interleukin-12 SC twice weekly beginning on day 2 and continuing until disease progression.

Group Type EXPERIMENTAL

rituximab

Intervention Type BIOLOGICAL

Given IV

recombinant interleukin-12

Intervention Type BIOLOGICAL

Given SC

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

questionnaire administration

Intervention Type OTHER

Ancillary studies

quality-of-life assessment

Intervention Type PROCEDURE

Ancillary studies

Arm II (rituximab and recombinant interleukin-12)

Patients receive rituximab as in arm I. Patients are evaluated at week 12. Patients with stable or progressive disease receive interleukin-12 SC twice weekly until disease progression or for 24 weeks. Patients with a complete or partial response after rituximab are monitored until disease progression and then begin interleukin-12 SC twice weekly until further disease progression.

Group Type EXPERIMENTAL

rituximab

Intervention Type BIOLOGICAL

Given IV

recombinant interleukin-12

Intervention Type BIOLOGICAL

Given SC

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

questionnaire administration

Intervention Type OTHER

Ancillary studies

quality-of-life assessment

Intervention Type PROCEDURE

Ancillary studies

Interventions

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rituximab

Given IV

Intervention Type BIOLOGICAL

recombinant interleukin-12

Given SC

Intervention Type BIOLOGICAL

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

questionnaire administration

Ancillary studies

Intervention Type OTHER

quality-of-life assessment

Ancillary studies

Intervention Type PROCEDURE

Other Intervention Names

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IDEC-C2B8 IDEC-C2B8 monoclonal antibody Mabthera MOAB IDEC-C2B8 Rituxan cytotoxic lymphocyte maturation factor IL-12 interleukin-12 natural killer cell stimulatory factor Ro 24-7472 quality of life assessment

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed CD20-positive B-cell non-Hodgkin's lymphoma
* Previously treated low-grade lymphoma considered incurable with standard therapy

* Grade I or II follicular lymphoma\*
* Lymphoplasmacytic lymphoma\*
* Small lymphocytic lymphoma\*
* Nodal marginal zone lymphoma\*
* Extranodal marginal zone lymphoma of MALT type\*
* Splenic marginal zone lymphoma\*
* Previously treated mantle cell lymphoma allowed
* Meets one of the following criteria for measurable disease:

* Bidimensional diameter at least 1.5 cm by 1.5 cm on physical exam
* At least 2 cm in one dimension by CT scan, MRI, or plain radiograph imaging
* Palpable spleen at least 5 cm below the left costal margin
* No CNS involvement by lymphoma
* Performance status - ECOG 0-1
* At least 12 weeks
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 75,000/mm\^3
* Hemoglobin ≥ 8 g/dL
* Bilirubin ≤ 3 times upper limit of normal (ULN)
* AST and ALT ≤ 3 times ULN
* Alkaline phosphatase ≤ 3 times ULN
* Creatinine ≤ 2 times ULN
* No New York Heart Association class III or IV heart disease
* No history of angina
* No uncontrolled peptic ulcer disease
* No uncontrolled infection
* No other active malignancy
* No autoimmune-related phenomena (e.g., antinuclear antibody less than 2 times ULN, rheumatoid factor less than 2 times ULN, and negative direct Coombs)
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Prior stem cell transplantation allowed
* More than 12 months since prior rituximab
* No prior interleukin-12
* No other concurrent immunotherapy
* Recovered from prior chemotherapy
* No concurrent chemotherapy
* No concurrent steroid therapy
* No concurrent radiotherapy
* Any number of prior therapies allowed

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen Ansell

Role: PRINCIPAL_INVESTIGATOR

North Central Cancer Treatment Group

Locations

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North Central Cancer Treatment Group

Rochester, Minnesota, United States

Site Status

Countries

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Canada United States