Status:
TERMINATED
Vaccine Therapy in Treating Patients With Myelodysplastic Syndromes
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Alliance for Cancer Gene Therapy
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
RATIONALE: Vaccines made from cancer cells may help the body build an effective immune response to kill abnormal cells. PURPOSE: This clinical trial is studying how well vaccine therapy works in trea...
Detailed Description
OBJECTIVES: Primary * Determine the safety of GM-K562 cell vaccine in patients with myelodysplastic syndromes. * Determine the hematologic and cytogenetic response in patients treated with this vacc...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Pathologically confirmed myelodysplastic syndromes (MDS), including any of the following:
- Refractory anemia (RA)
- RA with ringed sideroblasts
- Refractory cytopenias with multilineage dysplasia (RCMD)
- RCMD with ringed sideroblasts
- RA with excess blasts 1 (5-9% blasts)
- RA with excess blasts 2 (10-19% blasts)
- Must have poor-risk MDS, defined by the following:
- At least 2 lineages involved
- Unfavorable cytogenetics (i.e., abnormalities of chromosome 5 or 7, 11q23, t\[6;9\], trisomy 8, inv3, or multiple/complex karyotype)
- Transfusion requirement of \> 2 units of packed red blood cells monthly
- No chronic myelomonocytic leukemia
- No transformation to acute myeloid leukemia
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Creatinine \< 2.5 mg/dL
- Bilirubin \< 2.5 mg/dL (unless due to Gilbert's syndrome)
- Room air oxygen saturation ≥ 94% at rest
- Fertile patients must use effective contraception
- Negative pregnancy test
- No other malignancy within the past 5 years except in situ cervical cancer or adequately treated nonmelanoma skin cancer
- No active autoimmune disease or history of autoimmune disease requiring systemic immunosuppressants including, but not limited to, any of the following:
- Autoimmune hemolytic anemia
- Idiopathic thrombocytopenia purpura
- Inflammatory bowel disease
- Vasculitis
- Thyroiditis
- Rheumatic illnesses
- No known HIV serum antibody positivity
- No other disease requiring long-term corticosteroids or other immunosuppressants, such as severe chronic obstructive pulmonary disease or asthma
- PRIOR CONCURRENT THERAPY:
- At least 2 weeks since prior systemic corticosteroids or other immunosuppressants (e.g., cyclosporine, azathioprine, tacrolimus, or mycophenolate mofetil)
- At least 3 weeks since prior growth factors
- At least 2 months since prior azacitidine for MDS
- No prior bone marrow or other organ transplantation
- No concurrent cytotoxic-based therapy for MDS
- No other concurrent growth factors, including epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF)
Exclusion
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00361296
Start Date
September 1 2007
End Date
January 1 2010
Last Update
March 23 2023
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231