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Osteosarcoma: Outcome of Therapy Based on Histologic Response. A Collaborative Effort of the POB/NCI, Texas Children's Hospital and University of Oklahoma.


Phase 2
N/A
25 Years
Open (Enrolling)
Both
Cardiac Toxicity, Sarcoma

Thank you

Trial Information

Osteosarcoma: Outcome of Therapy Based on Histologic Response. A Collaborative Effort of the POB/NCI, Texas Children's Hospital and University of Oklahoma.


OBJECTIVES:

- Determine the rate of in vivo histologic response in patients with osteosarcoma treated
with neoadjuvant cisplatin, methotrexate, and doxorubicin with dexrazoxane (as
cardioprotection).

- Determine the event-free and overall survival of patients with nonmetastatic disease
who show good response to neoadjuvant therapy and receive adjuvant therapy with the
same regimen.

- Determine the event-free survival of patients with nonmetastatic disease who show poor
response to neoadjuvant therapy and receive adjuvant therapy with the same regimen.

- Determine the event-free survival and overall survival of patients with metastatic
disease who receive neoadjuvant therapy.

OUTLINE: This is a multicenter study.

- Neoadjuvant therapy: Patients receive neoadjuvant chemotherapy comprising dexrazoxane
IV over 15 minutes, doxorubicin IV over 15 minutes, and cisplatin IV over 4 hours on
days 1 and 2 in week 0. Patients also receive methotrexate IV over 4 hours followed by
leucovorin calcium in weeks 3 and 4. Patients then receive filgrastim (G-CSF)
subcutaneously (SC) once daily beginning 24 hours after completion of chemotherapy and
continuing until blood counts recover. Treatment repeats every 5 weeks for 2 courses in
the absence of disease progression or unacceptable toxicity.

- Surgical resection: Patients undergo definitive surgery in week 11.

- Adjuvant therapy: Patients receive dexrazoxane, doxorubicin, cisplatin, methotrexate,
and leucovorin calcium as in neoadjuvant therapy*. Treatment repeats every 5 weeks for
up to 4 courses in the absence of disease progression or unacceptable toxicity.

NOTE: *Cisplatin is not administered in courses 3 and 4 of adjuvant therapy

Patients are followed within 4 weeks, every 3 months for 2 years, every 6 months for 2
years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed newly diagnosed osteosarcoma

- No more than 1 month since prior diagnostic biopsy

- Nonmetastatic malignant high-grade osteosarcoma of bone

- Histologically confirmed metastatic disease allowed

- Unresectable primary disease allowed

- No low-grade, parosteal, or periosteal osteosarcoma

PATIENT CHARACTERISTICS:

Age:

- 25 and under

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 8.0 g/dL

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

- ALT less than 5 times normal

Renal:

- Creatinine no greater than 1.5 times normal

- Creatinine clearance or radioisotope glomerular filtration rate greater than 70
mL/min

Cardiovascular:

- Shortening fraction at least 27% by echocardiogram or MUGA

- Ejection fraction at least 45% by echocardiogram or MUGA

Other:

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

- No other concurrent chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

Surgery:

- Not specified

Other:

- No other concurrent therapy with no evidence of progressive disease

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of in vivo histologic response

Safety Issue:

No

Principal Investigator

Ramzi Dagher, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000067263

NCT ID:

NCT00019864

Start Date:

March 2000

Completion Date:

Related Keywords:

  • Cardiac Toxicity
  • Sarcoma
  • cardiac toxicity
  • localized osteosarcoma
  • metastatic osteosarcoma
  • recurrent osteosarcoma
  • Osteosarcoma
  • Sarcoma

Name

Location

Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral OfficeBethesda, Maryland  20892-1182
Texas Children's Cancer Center and Hematology Service at Texas Children's HospitalHouston, Texas  77030-2399