MDACC Study Summary COGAOST0331

Study Summary
No. COGAOST0331:.......Advanced Cancers; Bone; Pediatrics; Sarcoma......Peter M. Anderson......Pediatrics

Study Summary Title



Study Summary Number:	COGAOST0331

Study Title:	A randomized trial of the European and American Osteosarcoma Study Group to optimize treatment strategies for resectable osteosarcoma based on histological response to pre-operative chemotherapy (IND# 12697)

Physician

New Patient Referral



Name:	Peter M. Anderson	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Pediatrics	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6620 Contact us about clinical trials

General Information



Disease Group:	Advanced Cancers Bone Pediatrics Sarcoma	Supported By:	The Children's Oncology Group

Phase of Study:	Phase III	Return Visit:	Every 1-3 weeks

Treatment Agents:	Cisplatin Doxorubicin Etoposide Ifosfamide Methotrexate PEG Interferon Alpha-2b	Home Care:	This is a protocol currently used by Pediatric Oncologists in Corpus Christi, Austin, San Antonio, El Paso, and Dallas. Patients will return to MDACC for local control and scans

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	Length of stay is estimated 4-6 days , total # hospitalizations 18-21 (not counting surgery and fever & neutropenia). Pegylated Interferon administered on outpatient basis.

Description/
Intervention:

The goal of this clinical research study is to find out if adding the
chemotherapy drugs ifosfamide and etoposide to standard chemotherapy for
osteosarcoma will help treat the disease in patients who do not respond well to
standard chemotherapy alone. Researchers also want to find out if adding a
form of the chemotherapy drug interferon after standard chemotherapy can help
treat the disease in participants who have a good tumor response to standard
chemotherapy.

Study Objectives / Outcomes

To examine in a randomized setting, whether the addition of ifosfamide and etoposide (IE) to postoperative
chemotherapy with cisplatin, doxorubicin and methotrexate improves the event-free survival for
patients with resectable osteosarcoma and a poor histological response to 10 weeks of pre-operative
chemotherapy and whether the addition of pegylated interferon alfa-2b as maintenance
therapy after post-operative chemotherapy with cisplatin, doxorubicin and methotrexate improves the
event-free survival for patients with resectable osteosarcoma and a good histological response to 10
weeks of pre-operative chemotherapy.

Secondary objectives are:
1) To investigate whether the addition of IE to post-operative therapy for poor responders, and the addition of Peg-Intron as maintenance therapy for good responders, leads to an improvement in overall survival, short-term toxicity, long-term toxicity, and quality of life.
2)To investigate whether the addition of IE to post-operative therapy for poor responders, and the addition of Peg-Intron as maintenance therapy for good responders, leads to an improvement in event-free and overall survival in patients with localized osteosarcoma at entry.
3)To investigate whether biological or clinical correlates to histological response and outcome can be identified by encouraging enrollment on a COG osteosarcoma specimen collection study.
4)To examine the outcome of the entire cohort of patients.

Study Status Information



Study Activation / Registration Date:	12/19/2007

IRB Review and Approval Date:	09/06/2007

Study Type:	Phase Iii

Recruitment Status:	Closed

Projected Accrual:	2300

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients must be >/= 5 years and </= 40 years on date of diagnostic biopsy.

2) Patients must have high grade osteosarcoma. This includes second malignancies.

3) Submission of diagnostic biopsy for rapid central review of diagnostic biopsy materials is required on this study.

4) The site of the primary tumor must be in: Long bone of upper limb (C40.0) Short bone of upper limb (C40.1) Long bone of lower limb (C40.2) Short bone of lower limb (C40.3) Vertebral column (C41.2) Ribs, sternum, clavicle (C41.3) Pelvic bones, sacrum, coccyx (C41.4). Craniofacial osteosarcoma is NOT included.

5) All tumor (primary, metastatic, or both) is resectable or is expected to become resectable after the initial chemotherapy.

6) Patients age >/=16, must have a Karnofsky score >/= 50, or WHO/ECOG >/= 2. Patients age less than 16, must have a Lansky score >/= 50. Patients whose performance status is adversely affected by a pathologic fracture but who are able to undergo treatment are eligible.

7) Adequate renal function defined as: Glomerular Filtration Rate >/= 70 mL/min/1.73 square meter or Maximum Serum Creatinine based on age/gender as follows: 2 to < 6 years 0.8 mg/dL male or female; 6 to < 10 years 1 mg/dL male or female; 10 to < 13 years 1.2 mg/dL male or female; 13 to < 16 years 1.5 mg/dL male/ 1.4 mg/dL female; >/= 16 years 1.7 mg/dL male/ 1.4 mg/dL female.

8) Adequate cardiac function defined as shortening fraction of >/= 28% by echocardiogram, or ejection fraction of >/= 50% by radionuclide angiogram.

9) Adequate hematologic function defined as: neutrophils >/= 1.5 x 10^9/L (or WBC >/= 3 � 10^9/L if neutrophils are not available) and platelet count >/= 100 � 10^9/L.

10) Adequate liver function defined as: Total bilirubin </= 1.5 x upper limit of normal (ULN) for age.

11) Female patients must have a negative pregnancy test.

12) Female patients who are lactating must agree to stop breast-feeding.

13) Sexually active patients of childbearing potential must agree to use effective contraception.

14) Patients must be able to cooperate fully with all planned protocol therapy.

15) All patients and/or their parents or legal guardians must sign a written informed consent.

16) All institutional, FDA, and NCI requirements for human studies must be met.

Exclusion Criteria:

1) No previous treatment for osteosarcoma or previous chemotherapy for any disease. Previous radiotherapy for a prior cancer (other than osteosarcoma) is permitted.

2) Patients must not be known to be HIV positive. Testing for HIV is not mandatory.

Links

Registration Number: NCT00134030
Study Information on Clinical Trials Registry (clinicaltrials.gov)