Vaccine Therapy in Treating Patients With Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia - Full Text View

Sponsored by:	Gruppo Italiano Malattie EMatologiche dell'Adulto
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00466726

Purpose

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer.

PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with Philadelphia chromosome-positive chronic myelogenous leukemia.

Condition	Intervention	Phase
Leukemia	Drug: bcr-abl p210-b3a2 breakpoint-derived multipeptide vaccine Drug: sargramostim	Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Imatinib Imatinib mesylate Sargramostim Granulocyte-macrophage colony-stimulating factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label
Official Title:	Phase II Multicenter Study of P210-B3A2 Derived Peptide Vaccine in Chronic Myeloid Leukemia Patients in Complete Cytogenetic Response With Persistent Molecular Residual Disease During Imatinib Treatment

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response rate at 6 and 9 months [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction of molecular residual disease at 3 months [ Designated as safety issue: No ]
Reduction of molecular residual disease at 12 months [ Designated as safety issue: No ]
Rate of complete molecular response [ Designated as safety issue: No ]
In vivo and in vitro peptide-specific immune response induced by vaccination [ Designated as safety issue: No ]

Estimated Enrollment:	69
Study Start Date:	March 2007

Detailed Description:

OBJECTIVES:

Primary

Determine the activity of bcr-abl p210-b3a2 breakpoint-derived pentapeptide vaccine (CMLVAX100), in terms of peripheral blood bcr-abl/abl ratio reduction, in patients with Philadelphia chromosome-positive chronic myelogenous leukemia.

Secondary

Determine the reduction of molecular residual disease at 3 months in patients treated with this vaccine.
Determine the reduction of molecular residual disease at 12 months in patients treated with maintenance boosts of this vaccine.
Determine the rate of complete molecular response at any time after vaccination.
Determine in vivo and in vitro peptide-specific immune response induced by the vaccine.

OUTLINE: This is a prospective, nonrandomized, open-label, multicenter study.

Patients receive sargramostim (GM-CSF) subcutaneously (SC) on days 1 and 2 and bcr-abl p210-b3a2 breakpoint-derived pentapeptide vaccine (CMLVAX100) SC on day 2. Treatment repeats every 2 weeks for 6 courses. Patients then receive CMLVAX100 SC once monthly for 3 months and then once every 3 months for 6 months (for a total of 1 year). Patients may receive additional CMLVAX100 SC every 6 months for at least 3 years. Treatment continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 69 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of chronic myelogenous leukemia (CML) meeting the following criteria:
- Philadelphia chromosome positive disease
- b3a2 breakpoint mutation
Prior treatment with conventional imatinib mesylate for ≥ 18 months required
- Complete cytogenetic response documented on ≥ 2 different examinations
  - Persistence of molecularly detectable residual disease (any level of bcr-abl transcript)
- Patients continue to receive imatinib mesylate at the same dose (conventional treatment) during study treatment

PATIENT CHARACTERISTICS:

WHO performance status 0-1
Bilirubin ≤ 2 times upper limit of normal (ULN)
AST and ALT ≤ 2.5 times ULN
Creatinine ≤ 1.5 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No severe active infection or other serious medical illness that would preclude study completion
No known immunodeficiency
No autoimmune disorders

PRIOR CONCURRENT THERAPY:

No concurrent immunosuppression or systemic immunosuppressive medication
No concurrent dose escalation of imatinib mesylate
No other concurrent investigational products

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466726

Locations

Italy
Azienda Ospedale S. Luigi at University of Torino	Recruiting
Orbassano, Italy, 10043
Contact: Giuseppe Saglio, MD 39-011-902-6610
Federico II University Medical School	Recruiting
Naples, Italy, 80131
Contact: Bruno Rotoli, MD 39-081-746-2068 rotoli@unina.it
Nouvo Policlinico "LE SCOTTE'	Recruiting
Siena, Italy, 53100
Contact: Monica Bocchia, MD 39-057-758-6798
Ospedale Regionale A. Pugliese	Recruiting
Catanzaro, Italy, 88100
Contact: Antonia Peta, MD 39-961-883-346
Ospedale Sant' Eugenio	Recruiting
Rome, Italy, 00144
Contact: Sergio Amadori, MD 39-06-591-4745 mc7673@mclink.it
Universita Degli Studi di Bari	Recruiting
Bari, Italy, 70124
Contact: Vincenzo Liso, MD 39-080-547-8711
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore	Recruiting
Rome, Italy, 00168
Contact: Giuseppe Leone, MD 39-6-3015-4180 gleone@rm.unicatt.it
Policlinico Universitario Udine	Recruiting
Udine, Italy, 33100
Contact: Renato Fanin, MD 39-0432-239-300
Universita Degli Studi "La Sapeinza"	Recruiting
Rome, Italy, 00161
Contact: Roberto Foa, MD 39-6-8579-5753
Ospedali Riuniti di Bergamo	Recruiting
Bergamo, Italy, 24100
Contact: Alessandro Rambaldi, MD 39-35-269491

Sponsors and Collaborators

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

Study Chair:

Monica Bocchia, MD

Nouvo Policlinico "LE SCOTTE'

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000540577, GIMEMA-CML0206, EUDRACT-2006-006189-40, EU-20724
Study First Received:	April 25, 2007
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00466726
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

Philadelphia chromosome positive chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
relapsing chronic myelogenous leukemia

Study placed in the following topic categories:

Philadelphia Chromosome
Chromosomal abnormalities
Blast Crisis
Chronic myelogenous leukemia
Hematologic Diseases
Myeloproliferative Disorders
Leukemia, Myeloid

Leukemia, Myeloid, Chronic-Phase
Imatinib
Leukemia
Leukemia, Myeloid, Accelerated Phase
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Chromosome Aberrations
Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Neoplasms by Histologic Type
Translocation, Genetic

ClinicalTrials.gov processed this record on January 15, 2009