Wilm's Tumor 1 Protein Vaccine to Treat Cancers of the Blood
Leukemia, Acute Myelogenous (AML) · Leukemia, Acute Lymphocytic (ALL) · Leukemia, Chronic Myelogenous (CML) · Myelodysplastic Syndrome (MDS) · Non-Hodgkin's Lymphoma (NHL)
Bottom Line
View on ClinicalTrials.gov: NCT00923910 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- WT1 Peptide-Pulsed Dendritic Cells (Drug); Donor Lymphocytes (Drug); IL-4 (Drug); KLH (Drug); WT1 Peptides (Drug); Endotoxin (Drug); Diphenhydramine (Drug); Acetaminophen (Drug)
- Age
- Pediatric, Adult, Older Adult · 1+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Toxicity |
5 | — |
| PRIMARY Number of Participants With Graft Versus Host Disease (GVHD) Greater Than or Equal to Grade 3 |
— | — |
| SECONDARY Time to Immune Response |
12; NA; 8; 4; 3 | — |
| SECONDARY Wilm's Tumor 1 (WT1) Enzyme-Linked Immunospot (ELISpot) |
3; 2 | — |
| SECONDARY Wilm's Tumor (WT1) Delayed-type Hypersensitivity (DTH) |
2; 2; 1 | — |
| SECONDARY Keyhole Limpet Hemocyanin (KLH) Delayed-type Hypersensitivity (DTH) |
3; 1; 1 | — |
| SECONDARY Number of Participants With Progressive Disease |
5 | — |
Summary
Eligibility Criteria
- INCLUSION CRITERIA:
Inclusion Criteria: Patient (i.e., transplant recipient)
Age greater than 1 year and less than 75 years.
One of the following Wilm's Tumor 1 (WT1)-expressing hematologic malignancies:
- Acute lymphocytic leukemia (ALL), less than or equal to 25 percent marrow blasts.
- Acute myelogenous leukemia (AML), less than or equal to 25 percent marrow blasts.
- Chronic myelogenous leukemia (CML).
- Chronic phase, recurrent after or resistant to donor lymphocyte infusion (DLI) or resistant to available abl kinase inhibitors
- Accelerated phase, less than 20 percent marrow blasts
- Blastic phase, less than or equal to 25 percent marrow blasts
- Myelodysplastic syndrome (MDS), less than 20 percent marrow blasts.
- Non-Hodgkin's lymphoma (NHL), stage 4, less than or equal to 25 percent marrow blasts.
- Hodgkin's lymphoma (HL)
- There will be no restriction on the volume of extramedullary disease, with the exceptions of exclusions for central nervous system involvement or progression deemed unacceptably rapid.
WT1 expression will be confirmed by at least one of the following criteria:
- Greater than 15 percent of malignant cells react with anti-WT1 by immunohistochemistry.
- Positive quantitative reverse transcription polymerase chain reaction (RT-PCR) of WT1 compared with a negative control.
Human leukocyte antigen (HLA-A2) plus (heterozygous expression is acceptable).
Prior stem cell transplantation (SCT): Prior HLA-matched (5-6/6 antigen or 8-10/10 allele) related or unrelated allogeneic SCT required. Must be at least 42 days post-transplant, have had recovery of transplant-associated toxicity to less than grade 2, and have post-transplant donor engraftment as defined by donor chimerism greater than 50 percent (peripheral blood), neutrophil recovery to an absolute neutrophil count (ANC) greater than 500/microl independent of myeloid growth factors, and platelet recovery to greater than 20,000/microL independent of transfusion.
Disease status: Post-transplant residual or relapsed disease. Minimal residual disease (MRD) by polymerase chain reaction (PCR) or flow cytometry is acceptable in accordance with standard disease-specific diagnostic criteria.
Availability of previous allogeneic donor to donate cells again.
Prior therapy: Disease-specific therapy must be stopped at least 14 days prior to protocol Cycle 1 Day 1 (C1D1) and recovery of treatment-associated toxicity to greater than grade 2 is required prior to initiation of protocol therapy. Patients may have received prior DLI, but the last dose must be at least 28 days prior to C1D1 and there must be no active graft versus host disease (GVHD) greater than grade 1 acute or extensive chronic. Systemic immunosuppression must be stopped at least 28 days prior to protocol C1D1 and there must be no active GVHD greater than grade 1 acute or extensive chronic. There is no time restriction in regard to prior intrathecal chemotherapy provided there is complete recovery from any acute toxic effects of such. Patients receiving hydroxyurea are allowed.
Performance status of 0, 1, 2, or 3.
Renal function: Patients must have a serum creatinine less than or equal to 1.5 times the upper limit of normal based on age-specific normal range OR a creatinine clearance greater than or equal to 60 mL/min/1.73 m^2.
Hepatic function: Patients must have a total bilirubin less than or equal to 2.0 mg/dl and alanine aminotransferase (ALT) less than or equal to 5 times the upper limit of normal based on age- specific normal ranges.
Ability to give informed consent. For patients less than 18 years of age, their legal guardian must give informed consent. Pediatric patients will be included in age appropriate discussion in order to obtain verbal assent.
Recipients of unrelated donor transplants must sign a release of information form to authorize National Marrow Donor Program (NMDP) transfer of information to the National Institutes of Health (NIH).
Subjects of childbearing
Data sourced from ClinicalTrials.gov (NCT00923910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.