Combination Chemotherapy and Dexrazoxane Followed by Surgery and Radiation Therapy in Treating Patients With Advanced Soft Tissue Sarcoma or Recurrent Bone Sarcoma

Sponsor
City of Hope Medical Center
Study ID
NCT00544778
Phase
PHASE2
Status
Terminated

Conditions

  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • filgrastim — BIOLOGICAL
  • dexrazoxane hydrochloride — DRUG
  • doxorubicin hydrochloride — DRUG
  • ifosfamide — DRUG
  • irinotecan hydrochloride — DRUG
  • protein expression analysis — GENETIC
  • immunoenzyme technique — OTHER
  • adjuvant therapy — PROCEDURE
  • conventional surgery — PROCEDURE
  • neoadjuvant therapy — PROCEDURE
  • radiation therapy — RADIATION

Study Details

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, ifosfamide, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy. Giving combination chemotherapy together with dexrazoxane before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with dexrazoxane followed by surgery and radiation therapy works in treating patients with advanced soft tissue sarcoma or recurrent bone sarcoma.

Key Dates

Start date
Aug 31, 2001
Status verified
Aug 2014
Primary completion
Nov 30, 2011

Study Design

Enrollment
7 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    High-dose chemotherapy with doxorubicin at 120 mg/m2 and ifosfamide at 2 g/m2 followed by a prolonged schedule of CPT-11 at 20 mg/m2.

Primary Outcome Measure

Response Rate [ Time Frame: First disease evaluation one month after the start of treatment and every 3 months there after, up to 2 years. ]

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