I met with Dr Muzaffar Qazilbash at MDAnderson this morning to join 
his ongoing trial of Leukemia Vaccine. It sounded very promising to 
me. Is anyone else on this board in this trial?

Here is A write up that I found about it.

Meeting Dates: Dec 4th through Dec 7th, 2004 
Last Updated:
Wednesday Dec 8th, 2004 
Cancer Vaccine Produces Immune Response and Improves Survival in 
Patients With Leukemia

 
   Researchers at the M.D. Anderson Cancer Center in Houston have 
developed a vaccine that stimulates the immune system to seek out and 
destroy leukemia cells. Their study, the first to show complete 
molecular remission induced by peptide vaccination, was presented at 
the annual meeting of the American Society of Hematology, held in San 
Diego. 
   In research, the PR1 peptide (VLQELNVTV), a human leukemia-
associated antigen, was shown to produce an immune response in 20 of 
33 patients tested. Further, overall survival and cancer-free 
survival of responders were improved compared with nonresponders. 
   Several studies have established the PR1 peptide to be a human 
leukemia-associated antigen. PR1 is derived from proteinase 3, an 
aberrantly expressed protein in myeloid leukemia cells, and can be 
presented on HLA-A2 to cytotoxic T lymphocytes (CTL) that 
preferentially kill leukemia over normal hematopoietic progenitors. 
   In the research, 35 HLA-A2+ patients (median age = 50 [26-82]) 
with AML, MDS, and CML were vaccinated with the PR1 peptide in an 
incomplete Freund's adjuvant (Montanide ISA-51) and 75 mg of GM-CSF. 
Eligibility included AML with smoldering disease or >/= 2nd CR, CML 
not responding to upfront treatment or relapsed disease, and MDS with 
>/= 5% blasts. Patients were assigned at random to receive 0.25 mg, 
0.50 mg, or 1.0 mg PR1 SQ every three weeks for a total of three 
injections. Immune responses (IR) were assessed by PR1/HLA-A2 
tetramer staining and intracellular IFN-gamma production by CTL, and 
clinical responses were assessed by bone marrow biopsy before study 
entry and three weeks after the third vaccination. 
   The patients were treated at a median of 26 months from time of 
diagnosis, and follow up was one to four years. Toxicity was limited 
to grade 1 and 2 injection site reactions. Overall survival was 33% 
at four years. Immune responses (IR) were elicited in 20 of 33 
evaluable patients (60%). Of 16 patients with relapsed or refractory 
AML, there were four (25%) clinical responses (three CR, one PR). All 
four AML patients treated during CR remain in CR. Of 10 CML patients, 
there was one cytogentic CR. Three CML patients refractory to 
allogeneic transplant, interferon, and imatinib had stable disease 
with some hematological improvement since these patients were able to 
discontinue hydroxyurea and anagrelide. Of 5 MDS patients, there was 
one PR (17% blasts reduced to 4%). Overall survival at four years was 
14 of 20 patients with IR vs. 0 of 13 without IR (P<0.0001). 
Progression-free survival for patients with or without IR was 6.4 
months vs. 2.4 months, respectively (P=0.003). 
   The authors concluded that PR1 peptide vaccination is safe and can 
elicit both immunological and clinical responses in patients with 
refractory and relapsed myeloid leukemia, which improves progression-
free survival of patients who have an immune response to PR1.

Location:  San Diego, CA 






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