NCT00222443

Brief Summary

Determine toxicity and maximum tolerated dose of escalating daily protracted irinotecan, with weekly vincristine, temozolomide and vantin; to evaluate the feasibility of repetitive cycles of this chemotherapy and to estimate the response rate to this combination in children and adolescents with recurrent solid tumors and lymphomas.

Trial Health

87
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

Timeline
Completed

Started Sep 2004

Typical duration 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, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

September 22, 2008

Status Verified

September 1, 2008

Enrollment Period

3.2 years

First QC Date

September 20, 2005

Last Update Submit

September 19, 2008

Conditions

LymphomasTumors

Keywords

Recurrent solid tumorsrecurrent lymphomasPediatricsAdolescents

Outcome Measures

Primary Outcomes (2)

  • Determine toxicity and maximum tolerated dose of escalating daily protracted irinotecan.

  • Evaluate feasibility of repetitive cycles of this combination .

Secondary Outcomes (1)

  • Estimate response rate in children and adolescents with recurrent solid tumors and lymphomas.

Interventions

IrinotecanDRUG

Eligibility Criteria

Age1 Year - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Under age 21 years at time of study entry
  • Malignant solid tumor, including CNS tumors and lymphomas
  • Recurrent or refractory disease not amenable to other potentially curative therapies
  • At least three weeks since last myelosuppressive chemotherapy \> 6 months from allogeneic stem cell transplant
  • Adequate renal and hepatic function
  • Adequate peripheral blood counts unless bone marrow is involved

You may not qualify if:

  • Patients with leukemia not eligible
  • Patients with uncontrolled infection excluded
  • Patients who have received more than 4 prior chemotherapies
  • Patients who are receiving P450 enzyme-inducing anticonvulsants
  • Patients who are receiving any other cancer chemotherapy or any other investigational agent
  • Possible pregnancy will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oklahoma University Health Sciences Center-Jimmy Everest Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

LymphomaNeoplasms

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • William H Meyer, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

September 1, 2004

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

September 22, 2008

Record last verified: 2008-09

Locations

US(1)