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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01865 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| NCCTG-N0087 | |||
| CDR0000068994 | |||
| N0087 | Other Identifier | North Central Cancer Treatment Group | |
| N0087 | Other Identifier | CTEP | |
| U10CA025224 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (rituximab and recombinant interleukin-12) | Experimental | 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. |
|
| Arm II (rituximab and recombinant interleukin-12) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab | Biological | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response | The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. In addition, confidence intervals for the response probability will be calculated according to the approach of Duffy and Santner. | 12 weeks |
| Objective response | The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. In addition, confidence intervals for the response probability will be calculated according to the approach of Duffy and Santner. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate for MCL patients | Corresponding 95% confidence intervals will also be calculated. | Up to 5 years |
| Overall survival | The distribution this time measure will be estimated using the method of Kaplan-Meier. |
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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
Previously treated mantle cell lymphoma allowed
Meets one of the following criteria for measurable disease:
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
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Ansell | North Central Cancer Treatment Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Central Cancer Treatment Group | Rochester | Minnesota | 55905 | United States |
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| recombinant interleukin-12 | Biological | Given SC |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| questionnaire administration | Other | Ancillary studies |
|
| quality-of-life assessment | Procedure | Ancillary studies |
|
|
| From randomization to death due to any cause, assessed up to 5 years |
| Time to treatment failure | The distribution this time measure will be estimated using the method of Kaplan-Meier. | From randomization to the treatment-specific definition of disease progression, death, or when the patient goes off study due to refusal or toxicity, assessed up to 5 years |
| Complete response rate | Will be assessed and descriptively summarized. | Up to 5 years |
| Quality of life assessed using FACT-BRM | Before and after treatment comparisons will be made using a paired samples t-test or its nonparametric equivalent. This two-sided test will have at least 80% power to detect a moderate effect size (0.42 times the standard deviation) in the FACT-BRM scores. | Baseline |
| Quality of life assessed using FACT-BRM | Before and after treatment comparisons will be made using a paired samples t-test or its nonparametric equivalent. This two-sided test will have at least 80% power to detect a moderate effect size (0.42 times the standard deviation) in the FACT-BRM scores. | 3 months |
| Quality of life assessed using FACT-BRM | Before and after treatment comparisons will be made using a paired samples t-test or its nonparametric equivalent. This two-sided test will have at least 80% power to detect a moderate effect size (0.42 times the standard deviation) in the FACT-BRM scores. | 6 months |
| ID | Term |
|---|---|
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D053765 | Interleukin-12 Subunit p35 |
| D018664 | Interleukin-12 |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |
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