Leukemia Clinical Trial
Official title:
A Phase I Study of mAb 216 With Chemotherapy for the Treatment of Pediatric Patients With Relapsed or Refractory B-progenitor Acute Lymphoblastic Leukemia
This is a phase I trial in patients with relapsed or refractory leukemia of a human monoclonal antibody that kills B cell acute lymphoblastic leukemia. The trial will study the safety, pharmacokinetics, and anti-tumor activity of the antibody given as a single agent and with vincristine.
Status | Terminated |
Enrollment | 4 |
Est. completion date | July 2008 |
Est. primary completion date | April 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Months to 18 Years |
Eligibility |
Inclusion Criteria:- Patients must be > than 12 months at the time of study entry. - Patients must have had histologic verification of B-lineage ALL with bone marrow relapse or refractory disease that is unresponsive to traditional chemotherapy. - For patients WITHOUT prior allogeneic bone marrow transplant (BMT): - Second or subsequent bone marrow relapse - Primary refractory marrow disease - M3 marrow (> 25% blasts) - For patients WITH prior allogeneic BMT: - First or subsequent bone marrow relapse post-BMT - M3 marrow or M2 (> 5% and < 25% blasts) if cytogenetic or variable number tandem repeat (VNTR) confirmation - Confirmation of antibody reactivity - Patient's leukemic blasts (peripheral blood or marrow) must be documented to bind mAb 216 in vitro (Teng lab). - Patient's red blood cell (RBC) documented to NOT express fetal "i" antigen and RBC shown to NOT bind mAb 216 in vitro (Teng lab) - Patient must not be eligible for therapies of higher priority - Performance level Karnofsky 50% for patients > 10 years of age and Lansky >= 50 for patients <= 10 years of age. - Life expectancy must be at least 8 weeks. - Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study: - Myelosuppressive chemotherapy: must not have been received within 2 weeks of entry onto this study. - Biologic: at least 7 days since the completion of therapy with a biologic agent. - No hematologic criteria for white blood cell (WBC), hemoglobin (Hgb), or platelets - Patients with thrombocytopenia should be responsive to platelet transfusions and must not have uncontrolled bleeding. - Adequate renal function defined as: a serum creatinine that is less than or equal to 1.5 x normal for age - Adequate liver function defined as: total bilirubin <= 1.5 x upper limit of normal (ULN) for age, and SGPT (ALT) <= 5 x upper limit of normal (ULN) for age - Adequate cardiac function defined as: shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by gated radionuclide study. - All patients and/or their parents or legal guardians must sign a written informed consent/assent. - All Institutional Review Board (IRB) and Food and Drug Administration (FDA) requirements for human studies must be met. Exclusion Criteria:- Central nervous system (CNS) 3 or refractory CNS leukemia - Isolated extramedullary relapse - Uncontrolled infection - Lack of mAb 216 binding to patient's leukemic blasts in vitro - Binding of mAb 216 to the"i" antigen on patient's erythrocytes - Prior treatment with rituximab |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Stanford University School of Medicine | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Clare Twist | National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerable dose without toxicity | not known | Yes | |
Primary | Safety | unknown | Yes | |
Secondary | Decrease in leukemic blasts | unknown | No |
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