Status:
COMPLETED
Interferon and GM-CSF Compared With Imatinib Mesylate and Vaccine Therapy in Patients With Chronic Phase CML on a TKI
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Tyrosine kinase inhibitors may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Interferon alfa may interfere with the growth of cancer cells. GM-CSF ...
Detailed Description
OBJECTIVES: Primary * Compare clinical response, in terms of 1-year progression-free survival and rate of molecular complete remission, in patients with Philadelphia chromosome-positive chronic myel...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of chronic myelogenous leukemia (CML) in chronic phase based on cytogenetic detection of the Philadelphia chromosome and/or detection of the BCR-ABL rearrangement by any of the following molecular methods:
- Recombinant DNA analysis of the BCR-ABL fusion gene
- Fluorescence in situ hybridization (FISH)
- Polymerase chain reaction detection of the BCR-ABL hybrid mRNA
- Documentation of complete cytogenetic response by conventional cytogenetic or FISH analysis while on a stable dose of tyrosine kinase inhibitor
- No other phase of CML
- PATIENT CHARACTERISTICS:
- ECG performance status 0-2
- Life expectancy \> 24 months
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- Creatinine ≤ 2.0 mg/dL
- Bilirubin ≤ 2.0 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- No other malignancy within the past 5 years except in situ cervical carcinoma or adequately treated nonmelanoma skin cancer
- No other disease requiring long-term corticosteroids or immunosuppressants
- PRIOR CONCURRENT THERAPY:
- At least 28 days since prior investigational agents
- No prior bone marrow transplant or other transplant
- No concurrent immunosuppressants (e.g., steroids, cyclosporine, azathioprine, mycophenolate mofetil, sirolimus, or tacrolimus)
- No concurrent hydroxyurea, busulfan, or cytoreductive agents (other than frontline TKI)
- No other concurrent anticancer agents or therapies
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00363649
Start Date
September 1 2006
End Date
September 1 2017
Last Update
November 13 2018
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231