Rob,
That's a good question. Since all the other vaccine trials like
CMLVAX, you take Gleevec with the vaccine. I have given the protocol
below and it seems you take the PR1 peptide vaccine if you fail
standard therapy or as in Irene's case, intolerant to standard therapy
which would be Gleevec.
As far as I know, the PR1 peptide vaccine trial has been suspended.
I thank Cathy R for letting me know that. The trial has been last
updated Dec 2005 so it may again start soon. And it only had a few CML
patients, most patients were AML and MDS patients. We certainly should
be keeping an eye on this vaccine, though, since it is by stimulating
PR1 and eliciting an immune response that Interferon works. And that is
why you cannot have Interferon therapy with the vaccine since then they
would not know if it was the Interferon or the vaccine that was
eliciting the immune response. However, I do not see a trial
recruiting for PR1 peptide vaccine just now, just says it has been
suspended.
Anjana
Vaccine Therapy Plus Immune Adjuvant in Treating Patients With Chronic
Myeloid Leukemia, Acute Myeloid Leukemia, or Myelodysplastic Syndrome
This study has been suspended.
Verified by National Cancer Institute (NCI) November 2005
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004918
Purpose
RATIONALE: Vaccines made from peptides that are found on leukemia cells
may make the body build an immune response and kill cancer cells.
Combining vaccine therapy with the immune adjuvant Montanide ISA-51 may
be a more effective treatment for chronic myeloid leukemia, acute
myeloid leukemia, or myelodysplastic syndrome.
PURPOSE: This phase I/II trial is studying the side effects and best
dose of vaccine therapy when given with Montanide ISA-51 and to see how
well they work in treating patients with chronic myeloid leukemia,
acute myeloid leukemia, or myelodysplastic syndrome.
Condition Intervention Phase
Adult Acute Myeloid Leukemia
Atypical Chronic Myeloid Leukemia
Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
Chronic Myelogenous Leukemia
Myelodysplastic and Myeloproliferative Disease
Drug: Montanide ISA-51
Drug: PR1 leukemia peptide vaccine
Drug: sargramostim
Procedure: biological response modifier therapy
Procedure: colony-stimulating factor therapy
Procedure: cytokine therapy
Procedure: non-specific immune-modulator therapy
Procedure: non-tumor cell derivative vaccine
Procedure: vaccine therapy
Phase I
Phase II
MedlinePlus related topics: Anemia; Blood and Blood Disorders;
Bone Marrow Diseases; Cancer; Cancer Alternative Therapies;
Immune System and Disorders; Leukemia, Adult Acute; Leukemia, Adult
Chronic; Leukemia, Childhood; Lymphatic Diseases
Genetics Home Reference related topics: Anemia; Blood and Blood
Disorders; Cancer; Immune System and Disorders
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I/II Randomized Study of PR1 Leukemia Peptide
Vaccine and Montanide ISA-51 in Patients With Chronic Myeloid Leukemia,
Acute Myeloid Leukemia, or Myelodysplastic Syndromes
Further study details as provided by National Cancer Institute (NCI):
OBJECTIVES:
Determine the toxicity and immunological activity of PR1 leukemia
peptide vaccine administered with Montanide ISA-51 in patients with
chronic myeloid leukemia, acute myeloid leukemia, or myelodysplastic
syndromes.
Evaluate possible clinical efficacy of this vaccine in high-risk
HLA-A2-positive patients with myeloid leukemias.
OUTLINE: This is a phase I dose-escalation study of PR1 leukemia
peptide vaccine, followed by a phase II randomized study.
Patients receive PR1 leukemia peptide vaccine with Montanide ISA-51
(ISA-51) subcutaneously (SC) once every 3 weeks for 18 weeks, for a
total of 6 vaccinations. Patients also receive sargramostim (GM-CSF) SC
with each vaccination.
Cohorts of 3 patients receive escalating doses of PR1 leukemia peptide
vaccine until the maximum tolerated dose (MTD) is determined. The MTD
is defined as the dose preceding that at which 2 of 3 patients
experience dose-limiting toxicity.
Additional patients are accrued to the phase II portion of the study
and are randomized to receive one of three dose levels of PR1 leukemia
peptide vaccine with ISA-51. Patients in each of the 3 arms receive
treatment as in the phase I portion of the study.
Patients achieving a clinical response and/or clinical response to the
vaccine whose disease progresses within 6-12 months after the first set
of vaccinations may receive additional vaccine as before.
Patients achieving a clinical response or immune reaction to the
vaccine are followed at least monthly until death or until the clinical
response and/or immune reaction is lost.
PROJECTED ACCRUAL: A total of 3-9 patients will be accrued for the
phase I dose escalation portion of this study. A maximum of 60 patients
(20 per arm) will be accrued for the phase II randomized portion of
this study.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for
Study: Both
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of chronic myeloid leukemia in chronic phase or early
accelerated phase
Ineligible for bone marrow transplantation (BMT) or interferon OR
Failed standard therapy OR
Relapsed after BMT OR
Diagnosis of 1 of the following diseases and not a candidate for
chemotherapy:
Myelodysplastic syndromes in second or subsequent remission
Refractory anemia with excess blasts (RAEB) OR
RAEB in transformation
Acute myeloid leukemia (AML) in second or subsequent remission
AML with a smoldering presentation
HLA-A2 positive at one allele
PATIENT CHARACTERISTICS:
Age:
Over 18
Performance status:
ECOG 0-2
Life expectancy:
At least 9 weeks
Hematopoietic:
Not specified
Hepatic:
Bilirubin less than 3 mg/dL
ALT less than 3 times upper limit of normal
Renal:
Creatinine less than 2 mg/dL
Pulmonary:
FEV, FVC, and DLCO greater than 50% of predicted
No symptomatic pulmonary disease
Other:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other concurrent illness that severely limits life expectancy
No known history of Wegener's granulomatosis or other vasculitis
No known allergy to Montanide ISA-51
No active uncontrolled infection
No serologic antibody against proteinase 3
HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
See Disease Characteristics
No concurrent interferon
Chemotherapy:
See Disease Characteristics
No concurrent chemotherapy except hydroxyurea to control cell counts
Endocrine therapy:
At least 1 month since prior steroids
No concurrent steroids
Radiotherapy:
Not specified
Surgery:
Not specified
Other:
At least 1 month since prior cyclosporine or tacrolimus
No concurrent cyclosporine or tacrolimus
Location Information
Texas
M.D. Anderson Cancer Center at University of Texas, Houston,
Texas, 77030-1402, United States
Study chairs or principal investigators
Muzaffar H. Qazilbash, MD, Study Chair, M.D. Anderson Cancer Center
Richard E. Champlin, MD, M.D. Anderson Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ®
database
Study ID Numbers: CDR0000067600; MDA-DM-97325; NCI-T98-0017
Last Updated: December 8, 2005
Record first received: March 7, 2000
ClinicalTrials.gov Identifier: NCT00004918
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-05-19
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