Zoledronic Acid and Combination Chemotherapy in Treating Patients With Newly Diagnosed Metastatic Osteosarcoma

NCT00742924 | Completed Phase 1 Results DMC

• 3 other identifiers: AOST06P1CDR0000612613COG-AOST06P1
• Study Type: interventional
• Target: 24
• Locations: 4 countries
• Sites: 88

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This clinical trial is studying the side effects and best dose of zoledronic acid when given together with combination chemotherapy in treating patients with newly diagnosed metastatic osteosarcoma.

Conditions

Sarcoma

Keywords

metastatic osteosarcoma

Outcome Measures

Primary Outcomes (1)

• Limiting Toxicity

  The occurrence of Limiting Toxicity defined as Any CTC AE version 4 Grade 3 and 4 non-hematologic toxicity thought to be possibly, probably or definitely related to zoledronic acid with the specific exclusion of: * Grade 3 nausea and vomiting controlled with adequate antiemetic prophylaxis. * Grade 3 transaminase (AST/ALT) that occurs during the evaluation period but resolves to ≤ Grade 2, before the planned dose of therapy after definitive surgery. * Grade 3 fever or infection. * Grade 3 or 4 hypocalcemia (see Section 5.1.1) * Grade 3 mucositis. * Grade 3 fatigue that returns to ≤ Grade 2, before the planned dose of therapy after definitive surgery. * Grade 3 joint range of motion, decreased or joint effusion that is related to the primary tumor.

  Enrollment through the first 12 weeks of therapy.

Secondary Outcomes (4)

• Histologic Response as Assessed in the Primary Tumor and in Resected Metastases

  At definitive surgery planned for 12 weeks after the start of protocol therapy.

• Event-free Survival

  Time from study enrollment to disease recurrence, death without disease progression, diagnosis of a second malignant neoplasm, assessed up to 5 years

• Secondary Limiting Toxicity

  After week 13 to the end of protocol therapy

• Prognostic Value of Bone Resorption Markers

  At baseline and at weeks 13 and 36

Study Arms (4)

Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid

EXPERIMENTAL

(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery . (Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure. (Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC. See Detailed Description.

Drug: cisplatin; Drug: dexrazoxane hydrochloride; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: ifosfamide; Drug: leucovorin calcium; Drug: methotrexate; Drug: zoledronic acid; Procedure: adjuvant therapy; Procedure: neoadjuvant therapy; Procedure: therapeutic conventional surgery; Biological: filgrastim; Drug: Mesna

Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid

EXPERIMENTAL

(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery. (Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure. (Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC. See Detailed Description.

Drug: cisplatin; Drug: dexrazoxane hydrochloride; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: ifosfamide; Drug: leucovorin calcium; Drug: methotrexate; Drug: zoledronic acid; Procedure: adjuvant therapy; Procedure: neoadjuvant therapy; Procedure: therapeutic conventional surgery; Biological: filgrastim; Drug: Mesna

Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid

EXPERIMENTAL

(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery. (Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure. (Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC. See Detailed Description.

Drug: cisplatin; Drug: dexrazoxane hydrochloride; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: ifosfamide; Drug: leucovorin calcium; Drug: methotrexate; Drug: zoledronic acid; Procedure: adjuvant therapy; Procedure: neoadjuvant therapy; Procedure: therapeutic conventional surgery; Biological: filgrastim; Drug: Mesna

Chemotherapy and 2.3 mg/m2 Zoledronic Acid after MTD

EXPERIMENTAL

(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery. (Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure. (Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC. See Detailed Description.

Drug: cisplatin; Drug: dexrazoxane hydrochloride; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: ifosfamide; Drug: leucovorin calcium; Drug: methotrexate; Drug: zoledronic acid; Procedure: adjuvant therapy; Procedure: neoadjuvant therapy; Procedure: therapeutic conventional surgery; Biological: filgrastim; Drug: Mesna

Interventions

cisplatin DRUG

Given IV

Also known as: Cis-diamminedichloroplatinum II, CDDP, cis-DDP, Platinol-AQ, NSC #119875

Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid; Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid; Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid; Chemotherapy and 2.3 mg/m2 Zoledronic Acid after MTD

dexrazoxane hydrochloride DRUG

Given IV

Also known as: ICRF-187, ADR-529, ZINECARD, NSC #169780

Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid; Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid; Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid; Chemotherapy and 2.3 mg/m2 Zoledronic Acid after MTD

doxorubicin hydrochloride DRUG

Given IV

Also known as: Adriamycin, NSC #123127

Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid; Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid; Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid; Chemotherapy and 2.3 mg/m2 Zoledronic Acid after MTD

etoposide DRUG

Given IV

Also known as: VePesid, Etopophos, VP-16, NSC #141540

Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid; Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid; Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid; Chemotherapy and 2.3 mg/m2 Zoledronic Acid after MTD

ifosfamide DRUG

Given IV

Also known as: Isophosphamide, Iphosphamide, Z4942, Ifex, NSC #109724

Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid; Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid; Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid; Chemotherapy and 2.3 mg/m2 Zoledronic Acid after MTD

leucovorin calcium DRUG

Given IV or orally

Also known as: LCV, Wellcovorin, citrovorum factor, folinic acid, NSC #003590

Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid; Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid; Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid; Chemotherapy and 2.3 mg/m2 Zoledronic Acid after MTD

methotrexate DRUG

Given IV

Also known as: MTX, amethopterin, Trexall, NSC #000740

Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid; Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid; Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid; Chemotherapy and 2.3 mg/m2 Zoledronic Acid after MTD

zoledronic acid DRUG

Given IV

Also known as: 1-Hydroxy-2-imidazol-1-ylethylidene - diphosphonic acid, zoledronate, Zometa, Aclasta, NSC# 721517

Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid; Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid; Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid; Chemotherapy and 2.3 mg/m2 Zoledronic Acid after MTD

adjuvant therapy PROCEDURE

Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid; Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid; Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid; Chemotherapy and 2.3 mg/m2 Zoledronic Acid after MTD

neoadjuvant therapy PROCEDURE

Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid; Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid; Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid; Chemotherapy and 2.3 mg/m2 Zoledronic Acid after MTD

therapeutic conventional surgery PROCEDURE

Surgery of the primary tumor is scheduled for 12 weeks after the commencement of chemotherapy.

Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid; Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid; Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid; Chemotherapy and 2.3 mg/m2 Zoledronic Acid after MTD

filgrastim BIOLOGICAL

Given SC

Also known as: Granulocyte Colony-Stimulating Factor, r-metHuG-CSF, G-CSF, Neupogen, NSC #614629

Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid; Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid; Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid; Chemotherapy and 2.3 mg/m2 Zoledronic Acid after MTD

Mesna DRUG

Given IV

Also known as: sodium 2-mercaptoethane sulfonate, UCB 3983, Mesnex, NSC #113891

Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid; Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid; Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid; Chemotherapy and 2.3 mg/m2 Zoledronic Acid after MTD

Eligibility Criteria

• Age: Up to 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Biopsy-proven high-grade osteosarcoma within the past 6 weeks * Newly diagnosed disease * Metastatic disease * Resectable disease OR expected to become resectable after initial chemotherapy * Disease has arisen outside of areas of Paget's disease PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-2 OR Karnofsky PS 50-100% (for patients \> 16 years of age) OR Lansky PS 50-100% (for patients ≤ 16 years of age) * Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR maximum serum creatinine based on age/gender as follows: * 0.4 mg/dL (for patients 1 to 5 months of age) * 0.5 mg/dL (for patients 6 to 11 months of age) * 0.6 mg/dL (for patients 1 year of age) * 0.8 mg/dL (for patients 2 to 5 years of age) * 1 mg/dL (for patients 6 to 9 years of age) * 1.2 mg/dL (for patients 10 to 12 years of age) * 1.5 mg/dL (males) or 1.4 mg/dL (females) (for patients 13 to 15 years of age) * 1.7 mg/dL (males) or 1.4 mg/dL (females) (for patients ≥ 16 years of age) * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age * AST or ALT \< 2.5 times ULN for age * Shortening fraction ≥ 28% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram * ANC ≥ 1,000/mm³ * Platelet count ≥ 100,000/mm³ (transfusion independent) * Hemoglobin ≥ 10 g/dL (RBC transfusion allowed) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use contraception * No known HIV infection * No history of pericarditis, myocarditis, symptomatic arrhythmia, or conduction disturbances PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy * No other concurrent anticancer chemotherapy * No concurrent immunomodulating agents * Steroids for anti-emetic allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (88)

UAB Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Southern California Permanente Medical Group

Downey, California, 90027, United States

Location

Jonathan Jaques Children's Cancer Center at Miller Children's Hospital

Long Beach, California, 90801, United States

Location

Childrens Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Children's Hospital Central California

Madera, California, 93638-8762, United States

Location

Children's Hospital and Research Center Oakland

Oakland, California, 94609, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, 94304, United States

Location

Rady Children's Hospital - San Diego

San Diego, California, 92123-4282, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center

Farmington, Connecticut, 06360-2875, United States

Location

Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Nemours Children's Clinic - Orlando

Orlando, Florida, 32806, United States

Location

Sacred Heart Cancer Center at Sacred Heart Hospital

Pensacola, Florida, 32504, United States

Location

All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

St. Joseph's Cancer Institute at St. Joseph's Hospital

Tampa, Florida, 33607, United States

Location

Kaplan Cancer Center at St. Mary's Medical Center

West Palm Beach, Florida, 33407, United States

Location

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus

Atlanta, Georgia, 30322, United States

Location

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813, United States

Location

Mountain States Tumor Institute at St. Luke's Regional Medical Center

Boise, Idaho, 83712-6297, United States

Location

Children's Memorial Hospital - Chicago

Chicago, Illinois, 60614, United States

Location

Keyser Family Cancer Center at Advocate Hope Children's Hospital

Oak Lawn, Illinois, 60453, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1002, United States

Location

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, 40536-0093, United States

Location

Kosair Children's Hospital

Louisville, Kentucky, 40232, United States

Location

Maine Children's Cancer Program at Barbara Bush Children's Hospital

Scarborough, Maine, 04074-9308, United States

Location

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

Baltimore, Maryland, 21215, United States

Location

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

C.S. Mott Children's Hospital at University of Michigan Medical Center

Ann Arbor, Michigan, 48109-0286, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Butterworth Hospital at Spectrum Health

Grand Rapids, Michigan, 49503-2560, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-5381, United States

Location

Breslin Cancer Center at Ingham Regional Medical Center

Lansing, Michigan, 48910, United States

Location

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Cancer Clinic

Jackson, Mississippi, 39216-4505, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

Hackensack University Medical Center Cancer Center

Hackensack, New Jersey, 07601, United States

Location

Overlook Hospital

Morristown, New Jersey, 07962, United States

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131-5636, United States

Location

NYU Cancer Institute at New York University Medical Center

New York, New York, 10016, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

New York, New York, 10032, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, 28233-3549, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Akron Children's Hospital

Akron, Ohio, 44308-1062, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106-5000, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205-2696, United States

Location

Dayton Children's - Dayton

Dayton, Ohio, 45404-1815, United States

Location

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Knight Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

Penn State Children's Hospital

Hershey, Pennsylvania, 17033-0850, United States

Location

Palmetto Health South Carolina Cancer Center

Columbia, South Carolina, 29203, United States

Location

T.C. Thompson Children's Hospital

Chattanooga, Tennessee, 37403, United States

Location

East Tennessee Children's Hospital

Knoxville, Tennessee, 37901, United States

Location

Driscoll Children's Hospital

Corpus Christi, Texas, 78411, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Cook Children's Medical Center - Fort Worth

Fort Worth, Texas, 76104, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78207, United States

Location

Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229-3993, United States

Location

Primary Children's Medical Center

Salt Lake City, Utah, 84113-1100, United States

Location

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507-1971, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105, United States

Location

Providence Cancer Center at Sacred Heart Medical Center

Spokane, Washington, 99220-2555, United States

Location

West Virginia University Health Sciences Center - Charleston

Charleston, West Virginia, 25302, United States

Location

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449, United States

Location

Princess Margaret Hospital for Children

Perth, Western Australia, 6001, Australia

Location

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Children's & Women's Hospital of British Columbia

Vancouver, British Columbia, V6H 3V4, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Janeway Children's Health and Rehabilitation Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Hopital Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Saskatoon Cancer Centre at the University of Saskatchewan

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

San Jorge Children's Hospital

Santurce, 00912, Puerto Rico

Location

Related Publications (1)

• Goldsby RE, Fan TM, Villaluna D, Wagner LM, Isakoff MS, Meyer J, Randall RL, Lee S, Kim G, Bernstein M, Gorlick R, Krailo M, Marina N. Feasibility and dose discovery analysis of zoledronic acid with concurrent chemotherapy in the treatment of newly diagnosed metastatic osteosarcoma: a report from the Children's Oncology Group. Eur J Cancer. 2013 Jul;49(10):2384-91. doi: 10.1016/j.ejca.2013.03.018. Epub 2013 May 7.

  PMID: 23664013 DERIVED

MeSH Terms

Conditions

Sarcoma; Osteosarcoma

Interventions

Cisplatin; Dexrazoxane; Razoxane; Doxorubicin; Etoposide; etoposide phosphate; Ifosfamide; Leucovorin; Methotrexate; Zoledronic Acid; Chemotherapy, Adjuvant; Neoadjuvant Therapy; Filgrastim; Granulocyte Colony-Stimulating Factor; Mesna

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Diketopiperazines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Aminopterin; Diphosphonates; Organophosphonates; Imidazoles; Azoles; Combined Modality Therapy; Therapeutics; Drug Therapy; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids

Results Point of Contact

• Title: Results Reporting Coordinator
• Organization: Children's Oncology Group

resultsreportingcoordinator@childrensoncologygroup.org

352-273-0558

Study Officials

• Robert Goldsby, MD

  University of California, San Francisco

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2008
• First Posted: August 28, 2008
• Study Start: August 1, 2008
• Primary Completion: April 1, 2012
• Last Updated: July 4, 2014
• Results First Posted: July 4, 2014

Record last verified: 2014-06

Locations

CA (9); AU (1); PR (1); US (77)