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Interleukin-12 in Treating Patients With Previously Treated Non-Hodgkin's Lymphoma or Hodgkin's Disease
This study has been completed.
Study NCT00003210   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes

November 1, 1999
February 6, 2009
February 1998
 
 
 
Complete list of historical versions of study NCT00003210 on ClinicalTrials.gov Archive Site
 
 
 
Interleukin-12 in Treating Patients With Previously Treated Non-Hodgkin's Lymphoma or Hodgkin's Disease
A Phase II Study of Recombinant Human Interleukin-12 (rhIL-12) for the Treatment of Relapsed Lymphoma

RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill lymphoma cells.

PURPOSE: Phase II trial to study the effectiveness of interleukin-12 in treating patients with previously treated non-Hodgkin's lymphoma or Hodgkin's disease.

OBJECTIVES:

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

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.

Phase II
Interventional
Treatment, Open Label
Lymphoma
Biological: recombinant interleukin-12
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • 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 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.

PATIENT CHARACTERISTICS:

Age:

  • 16 and over

Performance status:

  • Zubrod 0-1
  • Karnofsky 80-100%

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • 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

Hepatic:

  • Bilirubin less than 1.5 mg/dL
  • SGOT/SGPT less than 2 times normal

Renal:

  • Creatinine no greater than 1.6 mg/dL
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

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

Pulmonary:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior allogeneic bone marrow or stem cell transplant
  • At least 3 weeks since prior biologic therapy for lymphoma

Chemotherapy:

  • At least 3 weeks since prior chemotherapy for lymphoma

Endocrine therapy:

  • No concurrent steroid therapy
  • At least 3 weeks since prior endocrine therapy for lymphoma

Radiotherapy:

  • At least 3 weeks since prior radiotherapy for lymphoma

Surgery:

  • At least 2 weeks since prior surgery
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003210
 
CDR0000066067, MDA-DM-97073, NCI-T97-0050
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Anas Younes, MD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
February 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP