NCT00077493

Brief Summary

RATIONALE: BL22 immunotoxin can locate tumor cells and kill them without harming normal cells. BL22 immunotoxin may be effective in treating relapsed or refractory acute lymphoblastic leukemia and non-Hodgkin's lymphoma. PURPOSE: This phase I trial is studying the side effects and best dose of BL22 immunotoxin in treating young patients with relapsed or refractory acute lymphoblastic leukemia or non-Hodgkin's lymphoma.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
95

participants targeted

Target at P75+ for phase_1 leukemia

Timeline
Completed

Started Jan 2004

Typical duration for phase_1 leukemia

Geographic Reach
1 country

1 active site

Status
suspended

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2004

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

December 28, 2007

Status Verified

December 1, 2007

Enrollment Period

4.8 years

First QC Date

February 10, 2004

Last Update Submit

December 21, 2007

Conditions

LeukemiaLymphoma

Keywords

recurrent childhood acute lymphoblastic leukemiaBurkitt lymphomarecurrent childhood large cell lymphomarecurrent childhood lymphoblastic lymphomachildhood non-Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

  • assessment of efficacy, safety, pharmacokinetics, immunogenicity.

    end of study

Secondary Outcomes (1)

  • Expansion of MTD

    end of study

Study Arms (4)

1

ACTIVE COMPARATOR

BL22 immunotoxin

Drug: BL22 immunotoxin

2

ACTIVE COMPARATOR

antibody therapy

Procedure: antibody-drug conjugate therapy

3

ACTIVE COMPARATOR

immunotoxin therapy

Procedure: immunotoxin therapy

4

ACTIVE COMPARATOR

monoclonal antibody therapy

Procedure: monoclonal antibody therapy

Interventions

BL22 immunotoxinDRUG

BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5 OR on days 1, 3, 5, 7, 9, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) or unconfirmed CR (CRu) receive 2 additional courses beyond CR or CRu for a maximum of 6 courses.

1
antibody-drug conjugate therapyPROCEDURE

CD22 antibody, RFB4 on day 7

2
immunotoxin therapyPROCEDURE

tested for immunogenicity to CAT-8015 before each cycle and at end of study.

3
monoclonal antibody therapyPROCEDURE

administered intravenously over 30 minutes.

4

Eligibility Criteria

Age6 Months - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * Histologically confirmed acute lymphoblastic leukemia (ALL) or non-Hodgkin's lymphoma (including lymphoblastic lymphoma, Burkitt's lymphoma, and large cell lymphoma) * Not amenable to available curative therapies * Relapsed or refractory disease after at least 1 standard chemotherapy and 1 salvage regimen * CD22 positive according to at least 1 of the following criteria: * More than 15% CD22-positive malignant cells by immunohistochemistry * More than 30% CD22-positive malignant cells by fluorescent-activated cell sorter analysis * Measurable or evaluable disease * Prior CNS involvement allowed provided there is no current evidence of CNS malignancy * No CNS leukemia or lymphoma as manifested by any of the following: * Cerebrospinal fluid (CSF) WBC ≥ 5/mm\^3 and confirmation of CSF blasts * Cranial neuropathies secondary to underlying malignancy * Radiologically detected CNS lymphoma * No isolated testicular ALL * Ineligible for or refused hematopoietic stem cell transplantation OR has disease activity that prohibits the time required to identify a suitable stem cell donor PATIENT CHARACTERISTICS: Age * 6 months to 24 years Performance status * ECOG 0-3 (12 to 24 years of age) * Lansky 40-100% (under 12 years of age) Life expectancy * Not specified Hematopoietic * See Disease Characteristics * Absolute neutrophil count \> 1,000/mm\^3 \* * Platelet count \> 50,000/mm\^3 \* NOTE: \*Non-leukemic patients only Hepatic * Bilirubin ≤ 2.0 mg/dL * AST and ALT ≤ 5 times upper limit of normal * No active hepatitis B or C infection Renal * Creatinine normal for age OR * Creatinine clearance ≥ 60 mL/min Immunologic * No serum neutralization of more than 75% of the activity of 1 µg/mL of study drug * HIV negative Other * 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 other significant organ dysfunction that would preclude study participation * No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * At least 1 week since prior colony-stimulating factors (e.g., filgrastim \[G-CSF\], sargramostim \[GM-CSF\], or epoetin alfa) * Prior autologous or allogeneic hematopoietic stem cell transplantation (HSCT) allowed * More than 100 days since prior allogeneic HSCT Chemotherapy * See Disease Characteristics * At least 2 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy * Concurrent corticosteroids allowed provided there has been no increase in the dose 1 week prior to and after study entry * Steroid taper allowed Radiotherapy * At least 3 weeks since prior radiotherapy * Allowed in the past 3 weeks provided the volume of the bone marrow treated is \< 10% AND the patients has measurable disease outside of the radiation port Surgery * Not specified Other * Recovered from prior therapy * At least 30 days since prior investigational drugs * No other concurrent investigational drugs

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

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaDendritic Cell Sarcoma, Interdigitating

Interventions

RFB4(dsFv)-PE38 recombinant immunotoxinAntibodies, Monoclonal

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, MalignantHistiocytosis

Intervention Hierarchy (Ancestors)

AntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Alan S. Wayne, MD

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 10, 2004

First Posted

February 12, 2004

Study Start

January 1, 2004

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

December 28, 2007

Record last verified: 2007-12

Locations

US(1)