NCT00003528

Brief Summary

Phase I trial to study the effectiveness of raltitrexed in treating children with refractory acute leukemia. 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
30

participants targeted

Target at P25-P50 for phase_1

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

September 1, 1998

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2002

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

March 1, 2004

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

3.8 years

First QC Date

November 1, 1999

Last Update Submit

January 15, 2013

Conditions

Recurrent Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • MTD based on incidence of DLT graded according to CTC version 2.0

    Up to 4 weeks

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive raltitrexed intravenously over 15 minutes once weekly for 3 weeks followed by 1 week of rest. Treatment continues in the absence of disease progression and unacceptable toxicity.

Drug: raltitrexed

Interventions

raltitrexedDRUG

Given IV

Also known as: D1694, ICI-D1694, TDX, Tomudex
Arm I

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically proven acute leukemia (M3 marrow) that is refractory to conventional therapy or for which no effective therapy exists
  • No CNS leukemia
  • No solid tumors
  • Performance status: Karnofsky 50-100% OR Lansky at least 50 (for infants)
  • Life expectancy: At least 8 weeks
  • Bilirubin less than 1.5 mg/dL
  • SGPT less than 5 times normal
  • Normal creatinine for age OR GFR at least 70 mL/min
  • No significant systemic illness such as infection
  • No significant third space fluid collection
  • Not pregnant or nursing
  • Recovered from acute toxic effects of prior immunotherapy
  • At least 6 months since prior bone marrow transplant with no evidence of graft-versus-host disease
  • At least 10 days since prior biologic therapy
  • At least 1 week since prior growth factors
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Pediatric Oncology Group - Geneva

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

raltitrexed

Condition Hierarchy (Ancestors)

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

Study Officials

  • Steven D. Weitman

    Swiss Pediatric Oncology Group - Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
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

March 1, 2004

Study Start

September 1, 1998

Primary Completion

June 1, 2002

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

CH(1)