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A Phase II Study of Recombinant Human Interleukin-12 (rhIL-12) for the Treatment of Relapsed Lymphoma and Hodgkin's Disease


Phase 2
16 Years
N/A
Not Enrolling
Both
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Splenic Marginal Zone Lymphoma, Waldenström Macroglobulinemia

Thank you

Trial Information

A Phase II Study of Recombinant Human Interleukin-12 (rhIL-12) for the Treatment of Relapsed Lymphoma and Hodgkin's Disease


PRIMARY OBJECTIVES:

I. Determine the response rate of interleukin-12 in previously treated patients with
non-Hodgkin's lymphoma or Hodgkin's disease.

II. To determine the in vivo regulatory effect of interleukin-12 on Fas lingand (FasL)
expression on patients' peripheral blood lymphocytes.

OUTLINE: Patients are stratified according to disease characteristics: low grade
non-Hodgkin's lymphoma (follicular small cleaved, follicular mixed, small lymphocytic, and
variants) versus intermediate grade non-Hodgkin's lymphoma (follicular large, diffuse large,
diffuse mixed, immunoblastic, peripheral T-cell, and mantle cell) versus Hodgkin's disease.

Patients receive interleukin-12 subcutaneously twice a week. Treatment repeats every 3 weeks
in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 36-105 patients will be accrued for this study.


Inclusion Criteria:



- Previously treated non-Hodgkin's lymphoma (all histologies except lymphoblastic and
Burkitt's lymphoma) or Hodgkin's disease

- Maximum of 4 previous treatment regimens

- Measurable disease

- No CNS involvement

- Performance status - Zubrod 0-1

- Performance status - Karnofsky 80-100%

- At least 12 weeks

- Platelet count at least 75,000/mm^3

- Absolute neutrophil count greater than 1500/mm^3

- Lymphocyte count greater than 500/mm^3

- Hemoglobin at least 8.0 g/dL

- Bilirubin less than 1.5 mg/dL

- SGOT/SGPT less than 2 times normal

- Creatinine no greater than 1.6 mg/dL

- Creatinine clearance at least 60 mL/min

- No severe cardiovascular disease including active ischemic heart disease, congestive
heart failure, or major arrhythmias

- No severe pulmonary disease including dyspnea with moderate to severe exertion

- HIV negative

- No active infection

- Not pregnant or nursing

- Fertile patients must use adequate contraception

- No clinically significant autoimmune disease (e.g. rheumatoid arthritis)

- No clinically significant gastrointestinal bleeding or uncontrolled peptic ulcer

- No prior allogeneic bone marrow or stem cell transplant

- At least 3 weeks since prior biologic therapy for lymphoma

- At least 3 weeks since prior chemotherapy for lymphoma

- No concurrent steroid therapy

- At least 3 weeks since prior endocrine therapy for lymphoma

- At least 3 weeks since prior radiotherapy for lymphoma

- At least 2 weeks since prior surgery

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Description:

Simon's two-stage model will be used.

Outcome Time Frame:

Up to 5 years

Safety Issue:

No

Principal Investigator

Anas Younes

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02264

NCT ID:

NCT00003210

Start Date:

February 1998

Completion Date:

Related Keywords:

  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Nodal Marginal Zone B-cell Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Diffuse Mixed Cell Lymphoma
  • Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
  • Recurrent Adult Hodgkin Lymphoma
  • Recurrent Adult Immunoblastic Large Cell Lymphoma
  • Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Mycosis Fungoides/Sezary Syndrome
  • Recurrent Small Lymphocytic Lymphoma
  • Splenic Marginal Zone Lymphoma
  • Waldenström Macroglobulinemia
  • Hodgkin Disease
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Waldenstrom Macroglobulinemia
  • Mycoses
  • Mycosis Fungoides
  • Sezary Syndrome
  • Lymphoma, B-Cell
  • Lymphoma, Large-Cell, Immunoblastic
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Mantle-Cell

Name

Location
M D Anderson Cancer Center Houston, Texas  77030