NCT00002970

Brief Summary

Phase II trial to study the effectiveness of 506U78 in treating patients with recurrent or refractory hematologic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

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

June 1, 1997

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.8 years until next milestone

First Posted

Study publicly available on registry

August 11, 2003

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Last Updated

July 2, 2013

Status Verified

July 1, 2013

Enrollment Period

7.6 years

First QC Date

November 1, 1999

Last Update Submit

July 1, 2013

Conditions

Recurrent Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Lymphoblastic LymphomaT-cell Childhood Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Early marrow CR plus PR rate at day 21

    CR is defined by an M1 marrow which requires blast counts below 5%. PR is defined by an M2 marrow which requires blast counts below 25%.

    Day 21

Secondary Outcomes (2)

  • Remission duration

    Up to 2 years

  • 6 month cumulative event-free survival

    6 months

Study Arms (1)

Arm I

EXPERIMENTAL

GROUP 1: Patients receive a 1 hour infusion of compound 506U78 daily for 5 days in the absence of neurologic toxicity. The course repeats every 21 days. If a first relapse T-cell ALL study of higher priority is not open, then the patient may continue to receive the drug every 21 days for a maximum of 2 years provided that the patient has achieved a second complete response. GROUPS 2 and 4: Patients receive compound 506U78 every 21 days for a maximum of 2 years, in the absence of disease progression. After 3 courses a patient may be given CNS prophylaxis with triple intrathecal therapy (TIT), consisting of methotrexate, cytarabine and hydrocortisone after consultation with study coordinator. TIT should be given every 12 weeks. GROUP 3: Patients receive compound 506U78 every 21 days for a maximum of 2 years, in the absence of disease progression. TIT will be given on day 1 of weeks 1-4, 6, 9 and every 6 weeks for 12 weeks, and then every 9 weeks thereafter. This stratum is open.

Drug: nelarabineDrug: methotrexateDrug: cytarabineDrug: therapeutic hydrocortisone

Interventions

nelarabineDRUG

Given IV

Also known as: 506U78, Arranon, GW506U78
Arm I
methotrexateDRUG

Given IT

Also known as: amethopterin, Folex, methylaminopterin, Mexate, MTX
Arm I
cytarabineDRUG

Given IT

Also known as: ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-U, cytosine arabinoside
Arm I
therapeutic hydrocortisoneDRUG

Given IT

Also known as: Aeroseb-HC, Barseb HC, Cetacort, Cort-Dome, Cortef
Arm I

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Refractory or recurrent acute lymphocytic leukemia (ALL) or non-Hodgkin's lymphoma (NHL) with bone marrow involvement (T-cell disease only)
  • Isolated CNS relapse not eligible
  • Performance status - Karnofsky 50-100%
  • At least 8 weeks
  • Bilirubin no greater than 1.5 mg/dL
  • SGPT less than 5 times normal
  • Creatinine normal for age
  • Creatinine clearance or GFR at least 60 mL/min/1.73m2
  • No severe uncontrolled infection
  • No concurrent biologic therapy
  • Recovered from toxic effects
  • At least 6 weeks from administration of nitrosoureas
  • No concurrent endocrine therapy
  • At least 6 weeks from administration of craniospinal or hemi pelvic radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Arcadia, California, 91006-3776, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

nelarabineMethotrexatemerphosCytarabineHydrocortisone

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Officials

  • Stacey Berg

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 11, 2003

Study Start

June 1, 1997

Primary Completion

January 1, 2005

Last Updated

July 2, 2013

Record last verified: 2013-07

Locations

US(1)