NCT00085150

Brief Summary

RATIONALE: LMB-2 immunotoxin can locate cancer cells and kill them without harming normal cells. PURPOSE: This phase I trial is studying the side effects and best dose of LMB-2 immunotoxin in treating young patients with relapsed or refractory leukemia or lymphoma.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 leukemia

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2004

Completed
Last Updated

April 30, 2015

Status Verified

February 1, 2007

First QC Date

June 10, 2004

Last Update Submit

April 29, 2015

Conditions

LeukemiaLymphoma

Keywords

recurrent adult T-cell leukemia/lymphomarecurrent childhood acute lymphoblastic leukemiachildhood Burkitt lymphomarecurrent childhood acute myeloid leukemiarecurrent childhood large cell lymphomarecurrent childhood lymphoblastic lymphomarecurrent mycosis fungoides/Sezary syndromerecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent/refractory childhood Hodgkin lymphomarelapsing chronic myelogenous leukemiaacute undifferentiated leukemia

Interventions

LMB-2 immunotoxinBIOLOGICAL

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of 1 of the following: * Non-Hodgkin's lymphoma, including the following subtypes: * Lymphoblastic lymphoma * Burkitt's lymphoma * Large cell lymphoma * Adult T-cell leukemia/lymphoma * Cutaneous T-cell lymphoma * Peripheral T-cell lymphoma * Hodgkin's disease * Acute myeloid leukemia * Chronic myelogenous leukemia * Acute lymphoblastic leukemia (ALL) * More than 5% blasts in the bone marrow (i.e., M2 marrow classification) * Acute hybrid leukemia, including the following subtypes: * Mixed lineage leukemia * Biphenotypic leukemia * Undifferentiated leukemia * CD25-positive (CD25+) disease, meeting 1 of the following criteria: * More than 15% of malignant cells are CD25+ by immunohistochemistry with anti-CD25 antibody * More than 30% of malignant cells from a site are CD25+ by fluorescence-activated cell sorting analysis * Measurable or evaluable disease * Relapsed or refractory disease after at least 1 standard chemotherapy regimen AND 1 salvage regimen * No available alternative curative therapies * Ineligible for or refused hematopoietic stem cell transplantation OR disease activity that prohibits the required time to identify a suitable stem cell donor * No CNS leukemia or lymphoma, as evidenced by any of the following criteria: * Cerebrospinal fluid (CSF) WBC \> 5/µl AND confirmation of CSF blasts * Cranial neuropathies secondary to underlying malignancy * CNS lymphoma detected by radiological imaging * Prior CNS involvement with no current evidence of CNS malignancy allowed * No isolated testicular ALL PATIENT CHARACTERISTICS: Age * 6 months to 21 years Performance status * ECOG 0-3 (≥ 12 years of age) * Lansky 40-100% (\< 12 years of age) Life expectancy * Not specified Hematopoietic * Pancytopenia due to disease allowed * For patients without bone marrow involvement: * Absolute neutrophil count \> 1,000/mm\^3 * Platelet count \> 50,000/mm\^3 (transfusion independent) Hepatic * Bilirubin ≤ 2.0 mg/dL * AST and ALT ≤ 5 times upper limit of normal * Hepatitis B surface antigen negative * Hepatitis C antibody negative Renal * Creatinine clearance ≥ 60 mL/min OR * Creatinine, meeting the following age-related criteria: * ≤ 0.8 mg/dL (≤ 5 years of age) * ≤ 1.0 mg/dL (6 to 10 years of age) * ≤ 1.2 mg/dL (11 to 15 years of age) * ≤ 1.5 mg/dL (\> 15 years of age) * Calcium 2.0-2.9 mmol/L Cardiovascular * Ejection fraction ≥ 45% by MUGA OR * Shortening fraction ≥ 28% by echocardiogram Pulmonary * Oxygen saturation ≥ 90% Other * Sodium 130-150 mmol/L * Potassium 3.0-5.5 mmol/L * Magnesium 0.5-1.23 mmol/L * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No clinically significant unrelated systemic illness that would preclude study participation * No conditions that would preclude study compliance * No serum that neutralizes \> 75% of the activity of 1 μg/mL of LMB-2 immunotoxin in tissue culture (due to either anti-toxin or anti-mouse immunoglobulin G antibodies) * No active graft-vs-host disease (i.e., off immunosuppression) PRIOR CONCURRENT THERAPY: Biologic therapy * Prior autologous bone marrow transplantation (BMT) allowed * At least 100 days since prior allogeneic BMT * At least 1 week since prior colony-stimulating factors (e.g., filgrastim \[G-CSF\], sargramostim \[GM-CSF\], or epoetin alfa) Chemotherapy * At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) except intrathecal chemotherapy * No other concurrent chemotherapy Endocrine therapy * Concurrent corticosteroids allowed provided the dose has been stable for the past week and does not increase during study treatment * Tapering or discontinuation of steroids allowed Radiotherapy * At least 3 weeks since prior radiotherapy unless \< 10% of marrow is irradiated and measurable disease exists outside the radiation port Surgery * Not specified Other * Recovered from all prior therapy * At least 30 days since prior investigational agents * Concurrent oral supplementation to maintain normal electrolyte levels allowed * No concurrent anticoagulation therapy for disease-related conditions * No other concurrent investigational agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (5)

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

Doernbecher Children's Hospital at Oregon Health & Science University

Portland, Oregon, 97239-3098, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaDendritic Cell Sarcoma, InterdigitatingMycosis FungoidesSezary SyndromeLymphoma, T-Cell, CutaneousRecurrenceLeukemia, Biphenotypic, Acute

Interventions

B3(Fv)-PE38KDEL recombinant immunotoxin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinHistiocytic Disorders, MalignantHistiocytosisLymphoma, T-CellDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alan S. Wayne, MD

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

June 10, 2004

First Posted

June 11, 2004

Study Start

April 1, 2004

Last Updated

April 30, 2015

Record last verified: 2007-02

Locations

US(5)