PMID- 17052486
OWN - NLM
STAT- MEDLINE
DCOM- 20061109
LR  - 20201222
IS  - 1097-6787 (Electronic)
IS  - 0190-9622 (Linking)
VI  - 55
IP  - 5
DP  - 2006 Nov
TI  - A phase II open-label study of recombinant human interleukin-12 in patients with 
      stage IA, IB, or IIA mycosis fungoides.
PG  - 807-13
AB  - BACKGROUND: Interleukin-12 (IL-12) increases Th(1) cytokines, natural killer (NK) 
      cells, and cytotoxic T-cell activities. Progression of mycosis fungoides is 
      associated with Th(2) cytokines produced by a clonal proliferation of 
      epidermotropic T-helper cells. OBJECTIVE: To determine the safety and efficacy of 
      subcutaneous recombinant human IL-12 (rhIL-12) in early mycosis fungoides (MF; 
      stage IA-IIA) in a multi-center, open label clinical trial. METHODS: rhIL-12 was 
      administered biweekly (100 ng/kg for 2 weeks; 300 ng/kg thereafter). A modified 
      severity-weighted assessment tool (SWAT) and the longest diameter of 5 index 
      lesions measured efficacy. RESULTS: Twenty-three MF patients (stage IA, 12 
      patients; IB, 9; and IIA, 2) had previously received >3 therapies. Ten of 23 
      patients (43%) achieved partial responses (PR); 7 (30%) achieved minor responses; 
      and 5 (22%) had stable disease. The duration of PRs ranged from 3 to more than 45 
      weeks. Twelve (52%) ultimately progressed with mean time to progressive disease 
      of 57 days (range, 28-805). Ten completed 6 months of therapy; 1 completed 24 
      months. Of patients not completing 6 months of therapy, 6 progressed and 6 others 
      discontinued because of adverse events or withdrew consent. Seventeen patients 
      had treatment-related adverse events that were generally mild or moderate in 
      severity, including asthenia, headache, chills, fever, injection site reaction, 
      pain, myalgia, arthralgia, elevated aspartate and alanine aminotransferase 
      levels, anorexia, and sweating. One patient in PR died of hemolytic anemia, 
      possibly exacerbated by rhIL-12 treatment. LIMITATIONS: The original company was 
      purchased during the conduct of the trial and rhIL-12 is currently unavailable. 
      The quality of life data were not available for inclusion. CONCLUSION: 
      Twice-weekly subcutaneously administered rhIL-12 (100 ng/kg escalated to 300 
      ng/kg) showed antitumor activity with a response rate of 43% in refractory 
      patients. It was relatively well-tolerated in early-stage MF.
FAU - Duvic, Madeleine
AU  - Duvic M
AD  - Department of Dermatology, University of Texas M.D. Anderson Cancer Center, 
      Houston, TX, 77030, USA. mduvic@mdanderson.org
FAU - Sherman, Matthew L
AU  - Sherman ML
FAU - Wood, Gary S
AU  - Wood GS
FAU - Kuzel, Timothy M
AU  - Kuzel TM
FAU - Olsen, Elise
AU  - Olsen E
FAU - Foss, Francine
AU  - Foss F
FAU - Laliberte, Robert J
AU  - Laliberte RJ
FAU - Ryan, John L
AU  - Ryan JL
FAU - Zonno, Kristilyn
AU  - Zonno K
FAU - Rook, Alain H
AU  - Rook AH
LA  - eng
GR  - M01RR00040/RR/NCRR NIH HHS/United States
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, N.I.H., Extramural
DEP - 20060908
PL  - United States
TA  - J Am Acad Dermatol
JT  - Journal of the American Academy of Dermatology
JID - 7907132
RN  - 0 (Adjuvants, Immunologic)
RN  - 0 (Recombinant Proteins)
RN  - 187348-17-0 (Interleukin-12)
SB  - IM
MH  - Adjuvants, Immunologic/administration & dosage/adverse effects/*therapeutic use
MH  - Disease Progression
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Injections, Subcutaneous
MH  - Interleukin-12/administration & dosage/adverse effects/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Mycosis Fungoides/*drug therapy/*pathology
MH  - Neoplasm Staging
MH  - Recombinant Proteins/administration & dosage/adverse effects/therapeutic use
MH  - Skin Neoplasms/*drug therapy/*pathology
MH  - Treatment Outcome
EDAT- 2006/10/21 09:00
MHDA- 2006/11/11 09:00
CRDT- 2006/10/21 09:00
PHST- 2005/11/05 00:00 [received]
PHST- 2006/05/25 00:00 [revised]
PHST- 2006/06/29 00:00 [accepted]
PHST- 2006/10/21 09:00 [pubmed]
PHST- 2006/11/11 09:00 [medline]
PHST- 2006/10/21 09:00 [entrez]
AID - S0190-9622(06)01872-X [pii]
AID - 10.1016/j.jaad.2006.06.038 [doi]
PST - ppublish
SO  - J Am Acad Dermatol. 2006 Nov;55(5):807-13. doi: 10.1016/j.jaad.2006.06.038. Epub 
      2006 Sep 8.