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Phase I Study of Interleukin-12 in Combination With Rituximab in Patients With Non-Hodgkin's Lymphoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma

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Trial Information

Phase I Study of Interleukin-12 in Combination With Rituximab in Patients With Non-Hodgkin's Lymphoma


OBJECTIVES: I. Determine the optimal immunological dose of interleukin-12 and rituximab when
administered in combination in patients with non-Hodgkin's lymphoma. II. Determine the
toxicities associated with this regimen in this patient population. III. Assess the
pharmacodynamics of this regimen in these patients. IV. Document observed clinical response
to this regimen in these patients.

OUTLINE: This is a dose escalation study of interleukin-12. Patients receive rituximab IV on
days 1, 8, 15, and 22. The first cohort of patients receives interleukin-12 SC twice weekly
beginning on day 29. Subsequent cohorts receive interleukin-12 SC twice weekly beginning on
day 16. Patients with stable or responding disease may continue treatment with
interleukin-12 twice weekly for up to 24 weeks or until disease progression. Cohorts of 6-9
patients receive escalating doses of interleukin-12 until the optimal immunological dose is
determined. The optimal immunological dose is defined as the dose preceding that at which 2
of 6 or 2 of 9 patients experience dose limiting toxicities or the dose at which there is a
maximal increase in gamma interferon, inducible protein-10 (IP-10) and immune cell
infiltration into the lymphoma (whichever dose is lower). Following initial dose escalation,
2 additional cohorts of 6 patients receive a fixed dose of interleukin-12 SC twice weekly
beginning on day 2. Patients are followed every 3 months for the first year, and then every
6 months for the next 4 years or until disease progression.

PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within 12-13
months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed CD20+ B-cell non-Hodgkin's lymphoma No
relapsed intermediate or high grade disease eligible for bone marrow or stem cell
transplant Intermediate or high grade disease must have received a prior anthracycline
containing regimen Low grade disease (with or without prior therapy) felt to be incurable
with standard therapy allowed No CNS involvement by lymphoma 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 0-1 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 75,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 3 times
upper limit of normal (ULN) AST/ALT less than 3 times ULN Renal: Creatinine no greater
than 2 times ULN Cardiovascular: No New York Heart Association class III or IV heart
disease No history of angina Other: Not pregnant or nursing Negative pregnancy test
Fertile patients must use effective contraception HIV negative No uncontrolled infection
No autoimmune related phenomena No peptic ulcer disease

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 12 months since prior rituximab No
prior interleukin-12 No other concurrent immunotherapy Chemotherapy: See Disease
Characteristics No prior fludarabine or 2-chlorodeoxyadenosine unless CD4 count normal
Recovered from prior chemotherapy No concurrent chemotherapy Endocrine therapy: No
concurrent steroid therapy Radiotherapy: No concurrent radiotherapy Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Stephen M. Ansell, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000067514

NCT ID:

NCT00004260

Start Date:

October 1999

Completion Date:

June 2003

Related Keywords:

  • Lymphoma
  • stage I grade 1 follicular lymphoma
  • stage I grade 2 follicular lymphoma
  • stage I grade 3 follicular lymphoma
  • stage I adult diffuse small cleaved cell lymphoma
  • stage I adult diffuse mixed cell lymphoma
  • stage I adult diffuse large cell lymphoma
  • stage I adult immunoblastic large cell lymphoma
  • stage I adult lymphoblastic lymphoma
  • stage I adult Burkitt lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult Burkitt lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • stage I mantle cell lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • contiguous stage II adult diffuse small cleaved cell lymphoma
  • contiguous stage II mantle cell lymphoma
  • contiguous stage II adult diffuse mixed cell lymphoma
  • contiguous stage II adult immunoblastic large cell lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • contiguous stage II adult Burkitt lymphoma
  • contiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage I marginal zone lymphoma
  • stage I small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • contiguous stage II marginal zone lymphoma
  • contiguous stage II small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Mayo ClinicRochester, Minnesota  55905