Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT00077285
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
N/A - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • filgrastim — BIOLOGICAL
  • carboplatin — DRUG
  • cyclophosphamide — DRUG
  • dexrazoxane hydrochloride — DRUG
  • doxorubicin hydrochloride — DRUG
  • etoposide — DRUG
  • ifosfamide — DRUG
  • irinotecan hydrochloride — DRUG
  • vincristine sulfate — DRUG
  • conventional surgery — PROCEDURE
  • radiation therapy — RADIATION

Study Details

RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin as upfront window therapy (first-line therapy) works in treating patients with newly diagnosed intermediate-risk or high-risk rhabdomyosarcoma.

Key Dates

Start date
Oct 31, 2003
Status verified
May 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
65 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: pts with intermediate- and high-risk rhabdomyosarcoma

Primary Outcome Measure

Response rate [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

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