Comparison of Chemotherapy Regimens in Treating Children With Relapsed or Progressive Rhabdomyosarcoma

Part of paid clinical trials in Arcadia, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00025363
Phase
PHASE2
Status
Completed

Conditions

  • Alveolar Childhood Rhabdomyosarcoma
  • Embryonal Childhood Rhabdomyosarcoma
  • Embryonal-botryoid Childhood Rhabdomyosarcoma
  • Previously Treated Childhood Rhabdomyosarcoma
  • Recurrent Childhood Rhabdomyosarcoma

Eligibility Criteria

Sex
ALL
Age
N/A - 20 Years
Healthy Volunteers
Not accepted

Interventions

  • vincristine sulfate — DRUG
    Given IV
  • irinotecan hydrochloride — DRUG
    Given IV
  • cyclophosphamide — DRUG
    Given IV
  • doxorubicin hydrochloride — DRUG
    Given IV
  • ifosfamide — DRUG
    Given IV
  • etoposide — DRUG
    Given IV
  • tirapazamine — DRUG
    Given IV
  • filgrastim — BIOLOGICAL
    Given SC
  • sargramostim — BIOLOGICAL
    Given SC
  • pharmacological study — OTHER
    Correlative studies
  • pharmacogenomic studies — OTHER
    Correlative studies
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

Randomized phase II trial to compare the effectiveness of different combination chemotherapy regimens in treating children who have rhabdomyosarcoma. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells

Key Dates

Start date
Nov 30, 2001
Status verified
Jan 2013
Primary completion
Oct 31, 2007

Study Design

Enrollment
150 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I
    Patients receive vincristine IV on days 1 and 8 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm II
    Patients receive vincristine IV on days 1 and 8 and irinotecan IV over 1 hour on days 1-5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Response at week 6 of investigational window therapy (unfavorable risk patients) [ Time Frame: At week 6 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Oncology GroupArcadiaCalifornia91006-3776-

Find similar trials in Arcadia, CA

By research site
Children's Oncology Group· Arcadia, CA

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