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Trial: NCT00003210 [RDF]

Label NCT00003210
Slug nct00003210
Trialid NCT00003210
Lookup name NCT00003210
Provenance http://clinicaltrials.gov/show/NCT00003210?displayxml=true
Lastchanged date April 14, 2015
Firstreceived results date
Firstreceived date November 1, 1999
Id info nct id NCT00003210
Overall status Completed
Id info secondary id NCI-2012-02264
Biospec retention
Required header link text Link to the current ClinicalTrials.gov record.
Enrollment 105
Number of arms 1
Is section 801 No
Is fda regulated Yes
Brief title Interleukin-12 in Treating Patients With Previously Treated Non-Hodgkin's Lymphoma or Hodgkin's Disease
Acronym
Official title A Phase II Study of Recombinant Human Interleukin-12 (rhIL-12) for the Treatment of Relapsed Lymphoma and Hodgkin's Disease
Study type Interventional
Id info nct alias
Completion date November 2003
Verification date January 2013
Why stopped
Id info org study id NCI-2012-02264
Required header url https://clinicaltrials.gov/show/NCT00003210
Study design Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Source National Cancer Institute (NCI)
Primary completion date November 2003
Brief summary
Number of groups
Required header download date ClinicalTrials.gov processed this data on September 08, 2016
Phase Phase 2
Start date February 1998
Has expanded access No
Biospec descr
Detailed description 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.
Condition browse 25aa16235600e79833fad7fa1d35336a
Intervention browse 6b0b576190a6f6c7c667c38790fe6d7f
Responsible party 015b495dfd0be1a85fcb46d41f363abd
Overall contact None
Overall contact backup None
Sponsor group c165a369fd9845217790cd90ac3d544c
Oversight info United States: Food and Drug Administration (Oversight_info)
Eligibility bfc5a7585cf323333fb99289fc9d6b8a
Keywords None
Conditions 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, Waldenstrom Macroglobulinemia
Locations 1dffa50415185faf405bd782dea3f9b8
Links None
Results references None
Arm groups Treatment (interleukin-12) (Arm Group)
Location countries United States
Interventions recombinant interleukin-12 (Intervention), laboratory biomarker analysis (Intervention)
Secondary outcomes 08b8c41a85777b2174fe6005a22fe725
References None
Primary outcomes 3225747b6abe86b40d57f7114604a3d3
Removed countries None
Overall officials b0cd64e47fb0aecc9b662d55c3f25e7b