Clincosm LogoSign in Get a demo

Study of mAb 216 With Chemotherapy for Treatment of Pediatric Relapsed or Refractory B-progenitor Acute Lymphoblastic Leukemia

Sponsor
Clare Twist (Other)
Overall Status
Terminated
CT.gov ID
NCT00313053
Collaborator
National Institutes of Health (NIH) (NIH)
4
Enrollment
1
Location
1
Arm
46
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Sep 1, 2004
Actual Primary Completion Date :
Apr 1, 2008
Actual Study Completion Date :
Jul 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Human mAb 216

Drug: Human mAb 216
Two treatment courses of mAb infusion will be given, with the same dose of antibody administered on Day 0 and on Day 7.

Drug: Vincristine
Vincristine 1.5 mg/m2/dose (max dose = 2 mg) IVP on weekly x 4 doses (Days 7, 14, 21, 28)

Outcome Measures

Primary Outcome Measures

  1. Maximum tolerable dose without toxicity []

  2. Safety []

Secondary Outcome Measures

  1. Decrease in leukemic blasts []

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Months to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University School of Medicine Stanford California United States 94305

Sponsors and Collaborators

  • Clare Twist
  • National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Clare J. Twist M.D., Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Clare Twist, Associate Professor of Pediatrics, Stanford University
ClinicalTrials.gov Identifier:
NCT00313053
Other Study ID Numbers:
  • PEDSMAB216
  • 95343
  • CA85199-01
  • PEDSMAB216
  • 13822
First Posted:
Apr 11, 2006
Last Update Posted:
Jun 3, 2016
Last Verified:
Nov 1, 2012
Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Vincristine

Study Results

No Results Posted as of Jun 3, 2016