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Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid Tumors

NCT00039481 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2013-01-17

No results posted yet for this study

Summary

Phase I trial to study the effectiveness of oblimersen plus combination chemotherapy and dexrazoxane in treating children and adolescents who have relapsed or refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of doxorubicin and cyclophosphamide by making the tumor cells more sensitive to the drug. Chemoprotective drugs such as dexrazoxane may protect normal cells from the side effects of chemotherapy

Conditions

  • Cardiac Toxicity
  • Unspecified Childhood Solid Tumor, Protocol Specific

Interventions

BIOLOGICAL

oblimersen sodium

Given IV

DRUG

dexrazoxane hydrochloride

Given IV

DRUG

doxorubicin hydrochloride

Given IV

DRUG

cyclophosphamide

Given IV

BIOLOGICAL

filgrastim

Given SC

OTHER

laboratory biomarker analysis

Correlative studies

OTHER

pharmacological study

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Susan Rheingold · Children's Oncology Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-30
Primary Completion
2005-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00039481 on ClinicalTrials.gov