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Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) in High Risk Ewing's Sarcoma Patients

NCT00038142 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2020-01-29

Study results available
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Summary

Objectives:

1. To determine if dose intensive Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) with or without ImmTherTM can improve the 2-year disease-free survival seen with standard VAC therapy.
2. To evaluate the feasibility and describe the toxicity associated with VACdxr.
3. To evaluate the feasibility and describe the toxicity of administering ImmTherTM on a weekly basis for 50- 52 weeks.
4. To determine which therapy (VACdxr+ or VACdxr-) is worthy of further evaluation.

Conditions

  • Ewing's Sarcoma

Interventions

DRUG

Vincristine

2.0 mg/m\^2 (max 2.0 mg) IV x 1 repeated every 3 weeks X 6.

DRUG

Doxorubicin

90 mg/m\^2 IV over 30 min x 1 repeated every 3 weeks X 6.

DRUG

Cyclophosphamide

2.0 g/m\^2 IV daily x 2 days repeated every 3 weeks X 6.

DRUG

Dexrazoxane

900 mg/m\^2 IV (30 min prior to doxorubicin) repeated every 3 weeks X 6.

BIOLOGICAL

ImmTher

900 mcg/m\^2 IV over 1 hour every week x 50-52 weeks.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Eugenie S. Kleinerman, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-11-30
Primary Completion
2016-03-31
Completion
2016-03-31

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 NCT00038142 on ClinicalTrials.gov