Oxaliplatin in Treating Young Patients With Recurrent Solid Tumors That Have Not Responded to Previous Treatment

Condition(s) targeted: Cancer

Intervention: oxaliplatin (Drug); chemotherapy (Procedure)

Phase: Phase 2

Status: No longer recruiting

Sponsored by: Children's Oncology Group

Official(s) and/or principal investigator(s):
Orren Beaty, DO, PhD, Study Chair, Affiliation: Mission Children's Hospital
Marcio A. Malogolowkin, MD, Affiliation: Children's Hospital Los Angeles
Stacey L. Berg, MD, Affiliation: Texas Children's Cancer Center

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well oxaliplatin works in treating young patients with recurrent solid tumors that have not responded to previous treatment.

Official title: A Phase II Study of Oxaliplatin in Children With Recurrent Solid Tumors

Study design: Interventional, Treatment, Open Label

Primary outcome:

Response rate

Cumulative toxicity

Pharmacokinetics

Time to progression

Overall survival

Correlation of the extent of drug exposure with response

Detailed description: OBJECTIVES:

* Determine the response rate in children with recurrent or refractory solid tumors treated with oxaliplatin.

* Determine the cumulative toxicity of this drug in these patients.

* Determine the pharmacokinetic profile of this drug in these patients.

* Determine time to progression and overall survival of patients treated with this drug.

* Correlate the extent of oxaliplatin exposure with response in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to disease type.

Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.

Maximum age: 21 Years. Gender(s): Both.

Criteria:

DISEASE CHARACTERISTICS:

* Histologically confirmed* solid tumor, including any of the following:

- Ewing's sarcoma/peripheral primitive neuroectodermal tumor (PNET)

- Osteosarcoma

- Rhabdomyosarcoma

- Neuroblastoma

- High-grade astrocytoma

- Low-grade astrocytoma

- Glioblastoma multiforme

- Ependymoma

- Hepatoblastoma

- Germ cell tumors of any site

- Rare tumors of interest, including any of the following:

+ Soft tissue sarcoma

+ Hepatocellular carcinoma

+ Childhood/adolescent colorectal carcinoma

+ Childhood/adolescent renal cell carcinoma

+ Childhood/adolescent adrenocortical carcinoma

+ Childhood/adolescent nasopharyngeal carcinoma NOTE: *Histologic confirmation not required for brain stem tumors and visual pathway gliomas

* Recurrent disease OR refractory to conventional therapy

* Measurable disease by clinical exam, CT scan, MRI, or positron emission tomography

PATIENT CHARACTERISTICS:

Age

* 21 and under at original diagnosis

Performance status

* Karnofsky 50-100% (for patients over age 10) OR

* Lansky 50-100% (for patients age 10 and under)

Life expectancy

* At least 8 weeks

Hematopoietic

* Absolute neutrophil count ≥ 1,000/mm^3*

* Platelet count ≥ 75,000/mm^3* (transfusion independent)

* Hemoglobin ≥ 8. 0 g/dL* (RBC transfusions allowed)

* Granulocytopenia, anemia, and/or thrombocytopenia due to bone marrow metastases or extensive prior radiotherapy allowed provided the above hematological criteria are met NOTE: *For patients without bone marrow involvement, including patients who underwent SCT

Hepatic

* Bilirubin ≤ 3 mg/dL

Renal

* Creatinine based on age as follows:

- ≤ .8 mg/dL (for patients age 5 and under)

- ≤ 1. 0 mg/dL (for patients age 6 to 10)

- ≤ 1. 2 mg/dL (for patients age 11 to 15)

- ≤1. 5 mg/dL (for patients age 16 to 21) OR

* Creatinine clearance or radioisotope glomerular filtration rate > 20 mL/min

Other

* No uncontrolled seizure disorder

* No uncontrolled infection

* CNS toxicity ≤ grade 2

* Not pregnant or nursing

* Negative pregnancy test

* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Recovered from prior immunotherapy

* At least 7 days since prior anticancer biologic therapy

* More than 1 week since prior growth factors

* At least 6 months since prior allogeneic stem cell transplantation

- No evidence of active graft-vs-host disease

* No concurrent immunomodulating agents

Chemotherapy

* Recovered from prior chemotherapy

* No prior oxaliplatin

* Prior carboplatin or cisplatin allowed

* More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)

* No other concurrent anticancer chemotherapy

Endocrine therapy

* Concurrent dexamethasone for CNS tumors allowed provided patient has been on a stable or decreasing dose for ≥ 1 week before study entry

Radiotherapy

* Recovered from prior radiotherapy

* At least 2 weeks since prior local palliative radiotherapy (small port)

* At least 6 months since prior craniospinal radiotherapy

* At least 6 months since prior radiotherapy to ≥ 50% of the pelvis

* At least 6 weeks since other prior substantial radiotherapy to the bone marrow

* Concurrent radiotherapy to localized painful lesions allowed provided ≥ 1 measurable lesion is not irradiated

Surgery

* Not specified

Other

* No other concurrent investigational agents

* No other concurrent anticancer agents

University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama 35294, United States

University of Alberta Hospital, Edmonton, Alberta T6G 1Z2, Canada

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States

Children's & Women's Hospital of British Columbia, Vancouver, British Columbia V6H 3V4, Canada

Children's Hospital and Health Center - San Diego, San Diego, California 92123-4282, United States

Children's Hospital Los Angeles, Los Angeles, California 90027, United States

Children's Hospital of Orange County, Orange, California 92868, United States

City of Hope Comprehensive Cancer Center, Duarte, California 91010-3000, United States

Kaiser Permanente Medical Center - Oakland, Sacramento, California 95825, United States

Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California 92354, United States

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles, California 90048-1865, United States

Southern California Permanente Medical Group, Downey, California 90242-2814, United States

Stanford Cancer Center at Stanford University Medical Center, Stanford, California 94305, United States

Sutter Cancer Center, Sacramento, California 95816, United States

UCSF Comprehensive Cancer Center, San Francisco, California 94115, United States

University of California Davis Cancer Center, Sacramento, California 95817, United States

Children's Hospital Cancer Center, Denver, Colorado 80218-1088, United States

Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center, Farmington, Connecticut 06360-2875, United States

Children's National Medical Center, Washington, District of Columbia 20010-2970, United States

All Children's Hospital, St. Petersburg, Florida 33701, United States

Broward General Medical Center Cancer Center, Ft. Lauderdale, Florida 33316, United States

Florida Hospital Cancer Institute at Florida Hospital Orlando, Orlando, Florida 32803-1273, United States

Kaplan Cancer Center at St. Mary's Medical Center, West Palm Beach, Florida 33407, United States

Lee Cancer Care of Lee Memorial Health System, Fort Myers, Florida 33901, United States

Miami Children's Hospital, Miami, Florida 33155, United States

Nemours Children's Clinic, Jacksonville, Florida 32207, United States

Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola, Florida 32504, United States

St. Joseph's Cancer Institute at St. Joseph's Hospital, Tampa, Florida 33607, United States

University of Florida Shands Cancer Center, Gainesville, Florida 32610-0232, United States

University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida 33136, United States

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia 31403-3089, United States

MBCCOP-Medical College of Georgia Cancer Center, Augusta, Georgia 30912-3730, United States

Winship Cancer Institute of Emory University, Atlanta, Georgia 30322, United States

Christchurch Hospital, Christchurch, New Zealand

Starship Children's Health, Auckland 1, New Zealand

San Jorge Children's Hospital, Santurce 00912, Puerto Rico

Cancer Research Center of Hawaii, Honolulu, Hawaii 95813, United States

Children's Memorial Hospital - Chicago, Chicago, Illinois 60614, United States

Southern Illinois University School of Medicine, Springfield, Illinois 62794-9620, United States

Indiana University Cancer Center, Indianapolis, Indiana 46202-5289, United States

St. Vincent Indianapolis Hospital, Indianapolis, Indiana 46260, United States

Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa 52242-1083, United States

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas 66160-7357, United States

Kosair Children's Hospital, Louisville, Kentucky 40232, United States

Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky 40536-0293, United States

CancerCare of Maine at Eastern Maine Medial Center, Bangor, Maine 04401, United States

Maine Children's Cancer Program, Scarborough, Maine 04074-9308, United States

CancerCare Manitoba, Winnipeg, Manitoba R3E 0V9, Canada

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore, Maryland 21215, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231-2410, United States

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States

Floating Hospital for Children at Tufts - New England Medical Center, Boston, Massachusetts 02111, United States

UMASS Memorial Cancer Center - University Campus, Worcester, Massachusetts 01655, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201-1379, United States

Breslin Cancer Center at Ingham Regional Medical Center, Lansing, Michigan 48910, United States

C.S. Mott Children's Hospital at University of Michigan, Ann Arbor, Michigan 48109-0238, United States

Hurley Medical Center, Flint, Michigan 48503, United States

Spectrum Health Cancer Care - Butterworth Campus, Grand Rapids, Michigan 49503-2560, United States

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan 48236, United States

Children's Hospitals and Clinics of Minneapolis, Minneapolis, Minnesota 55404, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

University of Minnesota Medical Center - Fairview, Minneapolis, Minnesota 55455, United States

University of Mississippi Medical Center, Jackson, Mississippi 39216-4505, United States

Cardinal Glennon Children's Hospital, St. Louis, Missouri 63104, United States

Children's Mercy Hospital, Kansas City, Missouri 64108, United States

Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri 65203, United States

Siteman Cancer Center at Barnes-Jewish Hospital, St. Louis, Missouri 63110, United States

Children's Hospital of Omaha, Omaha, Nebraska 68114-4113, United States

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey 08903, United States

Hackensack University Medical Center Cancer Center, Hackensack, New Jersey 07601, United States

Newark Beth Israel Medical Center, Newark, New Jersey 07112, United States

St. Barnabas Medical Center, Livingston, New Jersey 07039, United States

Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York 10461, United States

Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York 10032, United States

James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York 14642, United States

New York Medical College, Valhalla, New York 10595, United States

NYU Cancer Institute at New York University Medical Center, New York, New York 10016, United States

Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States

SUNY Upstate Medical University Hospital, Syracuse, New York 13210, United States

Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina 28232-2861, United States

Duke Comprehensive Cancer Center, Durham, North Carolina 27710, United States

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina 27599-7295, United States

Mission Hospitals - Memorial Campus, Asheville, North Carolina 28801, United States

Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina 28233-3549, United States

Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina 27157-1096, United States

CCOP - MeritCare Hospital, Fargo, North Dakota 58122, United States

IWK Health Centre, Halifax, Nova Scotia B3K 6R8, Canada

Children's Hospital Medical Center of Akron, Akron, Ohio 44308-1062, United States

Children's Medical Center - Dayton, Dayton, Ohio 45404-1815, United States

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229-3039, United States

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio 44195-5217, United States

Columbus Children's Hospital, Columbus, Ohio 43205-2696, United States

Medical University of Ohio Cancer Center, Toledo, Ohio 43614, United States

Rainbow Babies and Children's Hospital, Cleveland, Ohio 44106-5000, United States

Tod Children's Hospital - Forum Health, Youngstown, Ohio 44501, United States

Oklahoma University Medical Center, Oklahoma City, Oklahoma 73104, United States

Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, Ontario K7L 3N6, Canada

Children's Hospital of Eastern Ontario, Ottawa, Ontario K1H 8L1, Canada

Children's Hospital of Western Ontario, London, Ontario N6A 4G5, Canada

Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada

McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario L8N 3Z5, Canada

Cancer Institute at Oregon Health and Science University, Portland, Oregon 97239-3098, United States

Legacy Emanuel Hospital and Health Center & Children's Hospital, Portland, Oregon 97227, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104-9786, United States

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States

St. Christopher's Hospital for Children, Philadelphia, Pennsylvania 19134-1095, United States

Centre Hospitalier Universitaire de Quebec, Ste-Foy, Quebec G1V 4G2, Canada

CHUS-Hopital Fleurimont, Sherbrooke, Quebec J1H5N4, Canada

Hopital Sainte Justine, Montreal, Quebec H3T 1C5, Canada

Montreal Children's Hospital at McGill University Health Center, Montreal, Quebec H3H 1P3, Canada

Royal Children's Hospital, Herston, Brisbane, Queensland 4029, Australia

Rhode Island Hospital Comprehensive Cancer Center, Providence, Rhode Island 02903, United States

Saskatoon Cancer Centre at the University of Saskatchewan, Saskatoon, Saskatchewan S7N 4H4, Canada

Greenville Hospital System Cancer Center, Greenville, South Carolina 29605, United States

Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina 29425, United States

Palmetto Health South Carolina Cancer Center, Columbia, South Carolina 29203, United States

Sioux Valley Hospital and University of South Dakota Medical Center, Sioux Falls, South Dakota 57117-5039, United States

East Tennessee Children's Hospital, Knoxville, Tennessee 37916, United States

St. Jude Children's Research Hospital, Memphis, Tennessee 38105, United States

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee 37232-6310, United States

Baylor University Medical Center - Houston, Houston, Texas 77030-2399, United States

CCOP - Scott and White Hospital, Temple, Texas 76508, United States

Children's Hospital of Austin, Austin, Texas 78701, United States

Cook Children's Medical Center - Fort Worth, Fort Worth, Texas 76104-9958, United States

Covenant Children's Hospital, Lubbock, Texas 79410, United States

M.D. Anderson Cancer Center at University of Texas, Houston, Texas 77030-4009, United States

Medical City Dallas Hospital, Dallas, Texas 75230, United States

Methodist Children's Hospital of South Texas, San Antonio, Texas 78229-3993, United States

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas 75390, United States

Texas Tech University Health Sciences Center School of Medicine - Amarillo, Amarillo, Texas 79106, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78207, United States

Primary Children's Medical Center, Salt Lake City, Utah 84113-1100, United States

Royal Children's Hospital, Parkville, Victoria 3052, Australia

Children's Hospital of the King's Daughters, Norfolk, Virginia 23507-1971, United States

INOVA Fairfax Hospital, Fairfax, Virginia 22031, United States

Massey Cancer Center at Virginia Commonwealth University, Richmond, Virginia 23298-0037, United States

Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington 98105, United States

Edwards Comprehensive Cancer Center at Cabell Huntington Hospital, Huntington, West Virginia 25701, United States

Princess Margaret Hospital for Children, Perth, Western Australia 6001, Australia

Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin 54449, United States

Midwest Children's Cancer Center, Milwaukee, Wisconsin 53226, United States

St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin 54307-3508, United States

University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin 53792-6164, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: October 2004
Last updated: April 25, 2007