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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00006102
Other study ID # NCI-2012-01851
Secondary ID COG-P9963CDR0000
Status Completed
Phase Phase 2
First received August 3, 2000
Last updated February 4, 2013
Start date July 2000

Study information

Verified date November 2010
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Phase II trial to study the effectiveness of rebeccamycin analogue in treating children who have solid tumors or non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.


Description:

OBJECTIVES:

I. Determine the response in children with solid tumors or non-Hodgkin's lymphoma treated with rebeccamycin analogue.

II. Determine and maintain a plasma concentration of at least 5 µg/mL of this drug in these patients.

III. Determine the toxicity of this drug in these patients. IV. Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients with solid tumors are stratified according to tumor histology (neuroblastoma vs Ewing's sarcoma [closed to accrual as of 5/19/03]/peripheral primative neuroectodermal tumor [PNET] vs osteosarcoma [closed to accrual as of 5/19/03] vs rhabdomyosarcoma vs non-Hodgkin's lymphoma vs other solid tumors). Patients with CNS tumors are stratified according to tumor histology (medulloblastoma/PNET vs ependymoma vs brainstem glioma vs other CNS tumors).

Patients receive rebeccamycin analogue IV over 1 hour on day 1. Treatment continues every 21 days for a total of 16 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly for 1 year, every 2 months for 2 years, every 6 months for 1 year, and then annually thereafter.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender Both
Age group N/A to 21 Years
Eligibility DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed solid tumors

- Neuroblastoma

- Ewing's sarcoma/peripheral primitive neuroectodermal tumor (PNET)(Ewing's sarcoma closed to accrual as of 5/19/03)

- Osteosarcoma (closed to accrual as of 5/19/03)

- Rhabdomyosarcoma

- Other extracranial solid tumors

- CNS/brain tumors:

- Medulloblastoma/PNET

- Ependymoma

- Brainstem glioma

- Other CNS tumors

- Histological verification may be waived for brainstem glioma and classic optic glioma, but biopsy recommended OR

- Histologically or cytologically proven non-Hodgkin's lymphoma

- Refractory to standard treatment and no curative therapy available

- Measurable disease

PATIENT CHARACTERISTICS:

Age:

- 21 and under at time of original diagnosis

Performance status:

- Karnofsky 50-100% in patients over 10 years of age

- Lansky 50-100% in patients age 10 and under

Life expectancy:

- At least 8 weeks

Hematopoietic:

- Absolute neutrophil count greater than 1,000/mm^3

- Platelet count greater than 75,000/mm^3

- Hemoglobin greater than 8.0 g/dL

Hepatic:

- Bilirubin normal for age

- SGPT less than 2.5 times upper limit of normal

- Amylase normal

- Lipase normal

Renal:

- Creatinine normal for age OR

- Glomerular filtration rate at least 60 mL/min

Other:

- No concurrent uncontrolled infection

- Not pregnant or nursing

- Negative pregnancy test

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Recovered from prior immunotherapy

Chemotherapy:

- At least 6 weeks since prior nitrosourea and recovered

- Recovered from any other prior chemotherapy

- No more than two prior chemotherapy regimens

Endocrine therapy:

- CNS tumor patients receiving dexamethasone must be on stable or decreasing dose at least 2 weeks prior to study entry

Radiotherapy:

- At least 6 weeks since prior extended radiotherapy and recovered

- No prior total body irradiation

Surgery:

- Prior radiosurgery allowed

Other:

- No concurrent use of the following foods or medications:

- Grapefruit juice

- Erythromycin

- Azithromycin

- Clarithromycin

- Rifampin and analogues

- Fluconazole

- Ketoconazole

- Itraconazole

- Cimetidine

- Cannabinoids (marijuana or dronabinol)

- Leukotriene inhibitors (e.g., zafirlukast and zileuton)

- No other concurrent anticancer or investigational agents

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
becatecarin


Locations

Country Name City State
Australia Royal Children's Hospital Brisbane Queensland
Australia Women's and Children's Hospital North Adelaide South Australia
Australia Royal Children's Hospital Parkville Victoria
Australia Princess Margaret Hospital for Children Perth Western Australia
Australia Sydney Children's Hospital Randwick New South Wales
Australia Children's Hospital at Westmead Westmead New South Wales
Canada Alberta Children's Hospital Calgary Alberta
Canada Cross Cancer Institute Edmonton Alberta
Canada IWK Health Centre Halifax Nova Scotia
Canada Children's Hospital Hamilton Ontario
Canada Children's Hospital of Western Ontario London Ontario
Canada Hopital Sainte Justine Montreal Quebec
Canada McGill University Health Center - Montreal Children's Hospital Montreal Quebec
Canada Children's Hospital of Eastern Ontario Ottawa Ontario
Canada Allan Blair Cancer Centre Regina Saskatchewan
Canada Laval University Medical Center Sainte-Foy Quebec
Canada Saskatoon Cancer Centre Saskatoon Saskatchewan
Canada Janeway Children's Health and Rehabilitation Centre St. John's Newfoundland and Labrador
Canada Hospital for Sick Children Toronto Ontario
Canada British Columbia Children's Hospital Vancouver British Columbia
Canada CancerCare Manitoba Winnipeg Manitoba
Netherlands Academisch Ziekenhuis Groningen Groningen
New Zealand Starship Children's Hospital Auckland
Puerto Rico University of Puerto Rico School of Medicine Medical Sciences Campus San Juan
Puerto Rico San Jorge Childrens Hospital Santurce
Switzerland Swiss Pediatric Oncology Group Bern Bern
Switzerland Swiss Pediatric Oncology Group Geneva Geneva
Switzerland Swiss Pediatric Oncology Group Lausanne Lausanne
United States Children's Hospital Medical Center of Akron Akron Ohio
United States Cancer Center of Albany Medical Center Albany New York
United States University of New Mexico Cancer Research and Treatment Center Albuquerque New Mexico
United States Texas Tech University Health Sciences Center School of Medicine Amarillo Texas
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Mission St. Joseph's Health System Asheville North Carolina
United States Children's Healthcare of Atlanta - Scottish Rite Atlanta Georgia
United States Emory University Hospital - Atlanta Atlanta Georgia
United States Medical College of Georgia Comprehensive Cancer Center Augusta Georgia
United States Marlene and Stewart Greenebaum Cancer Center, University of Maryland Baltimore Maryland
United States Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland
United States Sinai Hospital of Baltimore Baltimore Maryland
United States Eastern Maine Medical Center Bangor Maine
United States University of Alabama at Birmingham Comprehensive Cancer Center Birmingham Alabama
United States Mountain States Tumor Institute Boise Idaho
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Floating Hospital for Children Boston Massachusetts
United States Albert Einstein Clinical Cancer Center Bronx New York
United States Brookdale University Hospital and Medical Center Brooklyn New York
United States Brooklyn Hospital Center Brooklyn New York
United States Maimonides Medical Center Brooklyn New York
United States State University of New York Health Science Center at Brooklyn College of Medicine Brooklyn New York
United States Roswell Park Cancer Institute Buffalo New York
United States Vermont Cancer Center Burlington Vermont
United States Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States West Virginia University - Charleston Charleston West Virginia
United States Carolinas Medical Center Charlotte North Carolina
United States Presbyterian Healthcare Charlotte North Carolina
United States Cancer Center at the University of Virginia Charlottesville Virginia
United States Children's Memorial Hospital - Chicago Chicago Illinois
United States Rush-Presbyterian-St. Luke's Medical Center Chicago Illinois
United States University of Chicago Cancer Research Center Chicago Illinois
United States University of Illinois at Chicago Chicago Illinois
United States Children's Hospital Medical Center - Cincinnati Cincinnati Ohio
United States Cleveland Clinic Taussig Cancer Center Cleveland Ohio
United States Ireland Cancer Center Cleveland Ohio
United States Palmetto Health South Carolina Cancer Center Columbia South Carolina
United States University of Missouri-Columbia Hospital and Clinics Columbia Missouri
United States Children's Hospital of Columbus Columbus Ohio
United States Medical City Dallas Hospital Dallas Texas
United States Simmons Cancer Center - Dallas Dallas Texas
United States Geisinger Medical Center Danville Pennsylvania
United States Children's Medical Center - Dayton Dayton Ohio
United States Children's Hospital of Denver Denver Colorado
United States Presbyterian-St Luke's Medical Center Denver Colorado
United States Raymond Blank Memorial Hospital for Children Des Moines Iowa
United States Children's Hospital of Michigan Detroit Michigan
United States Henry Ford Hospital Detroit Michigan
United States St. John Hospital and Medical Center Detroit Michigan
United States Southern California Permanente Medical Group Downey California
United States City of Hope Comprehensive Cancer Center Duarte California
United States St. Mary's/Duluth Clinic Cancer Center Duluth Minnesota
United States Duke Comprehensive Cancer Center Durham North Carolina
United States Michigan State University East Lansing Michigan
United States Inova Fairfax Hospital Falls Church Virginia
United States Dakota Cancer Institute Fargo North Dakota
United States University of Connecticut Health Center Farmington Connecticut
United States Hurley Medical Center Flint Michigan
United States Broward General Medical Center Fort Lauderdale Florida
United States Children's Hospital of Southwest Florida Fort Myers Florida
United States Cook Children's Medical Center - Fort Worth Fort Worth Texas
United States Shands Hospital and Clinics, University of Florida Gainesville Florida
United States University of Texas Medical Branch Galveston Texas
United States Spectrum Health and DeVos Children's Hospital Grand Rapids Michigan
United States Bellin Memorial Hospital Green Bay Wisconsin
United States CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay Wisconsin
United States St. Vincent Hospital Green Bay Wisconsin
United States Children's Hospital of Greenville Hospital System Greenville South Carolina
United States East Carolina University School of Medicine Greenville North Carolina
United States Hackensack University Medical Center Hackensack New Jersey
United States Milton S. Hershey Medical Center Hershey Pennsylvania
United States Joe DiMaggio Children's Hospital at Memorial Hollywood Florida
United States Cancer Research Center of Hawaii Honolulu Hawaii
United States Tripler Army Medical Center Honolulu Hawaii
United States Baylor College of Medicine Houston Texas
United States University of Texas - MD Anderson Cancer Center Houston Texas
United States Cabell-Huntington Hospital, Inc Huntington West Virginia
United States Indiana University Cancer Center Indianapolis Indiana
United States St. Vincent Hospital and Health Care Center Indianapolis Indiana
United States Holden Comprehensive Cancer Center Iowa City Iowa
United States University of Mississippi Medical Center Jackson Mississippi
United States Nemours Children's Clinic Jacksonville Florida
United States East Tennessee State University Cancer Center at JCMC Johnson City Tennessee
United States Bronson Methodist Hospital Kalamazoo Michigan
United States Children's Mercy Hospital Kansas City Missouri
United States East Tennessee Children's Hospital Knoxville Tennessee
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States Rebecca and John Moores UCSD Cancer Center La Jolla California
United States San Antonio Military Pediatric Cancer and Blood Disorders Center Lackland Air Force Base Texas
United States Sunrise Hospital and Medical Center Las Vegas Nevada
United States Norris Cotton Cancer Center Lebanon New Hampshire
United States Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States St. Barnabas Medical Center Livingston New Jersey
United States Loma Linda University Medical Center Loma Linda California
United States Jonathan Jaques Children's Cancer Center at Miller Children's Hospital Long Beach California
United States Cedars-Sinai Medical Center Los Angeles California
United States Children's Hospital Los Angeles Los Angeles California
United States Jonsson Comprehensive Cancer Center, UCLA Los Angeles California
United States Kosair Children's Hospital Louisville Kentucky
United States Covenant Children's Hospital Lubbock Texas
United States Medical Center of Central Georgia Macon Georgia
United States Children's Hospital Central California Madera California
United States Medical College of Ohio Hospital Madison Wisconsin
United States University of Wisconsin Comprehensive Cancer Center Madison Wisconsin
United States North Shore University Hospital Manhasset New York
United States Marshfield Clinic Marshfield Wisconsin
United States St. Jude Children's Research Hospital Memphis Tennessee
United States Baptist Hospital of Miami Miami Florida
United States Miami Children's Hospital Miami Florida
United States University of Miami-Jackson Memorial Hospital Miami Florida
United States Midwest Children's Cancer Center Milwaukee Wisconsin
United States Children's Hospitals and Clinics - Minneapolis Minneapolis Minnesota
United States University of South Alabama Medical Center Mobile Alabama
United States West Virginia University Hospitals Morgantown West Virginia
United States Vanderbilt-Ingram Cancer Center Nashville Tennessee
United States Cancer Institute of New Jersey New Brunswick New Jersey
United States Yale Comprehensive Cancer Center New Haven Connecticut
United States Schneider Children's Hospital New Hyde Park New York
United States Children's Hospital of New Orleans New Orleans Louisiana
United States Ochsner Clinic Foundation New Orleans Louisiana
United States Tulane University School of Medicine New Orleans Louisiana
United States Herbert Irving Comprehensive Cancer Center New York New York
United States Memorial Sloan-Kettering Cancer Center New York New York
United States Mount Sinai School of Medicine New York New York
United States New York Presbyterian Hospital - Cornell Campus New York New York
United States Newark Beth Israel Medical Center Newark New Jersey
United States Children's Hospital of the King's Daughters Norfolk Virginia
United States Advocate Hope Children's Hospital Oak Lawn Illinois
United States Children's Hospital of Oakland Oakland California
United States Children's Hospital of Oklahoma Oklahoma City Oklahoma
United States Children's Hospital of Omaha Omaha Nebraska
United States University of Nebraska Medical Center Omaha Nebraska
United States Chao Family Comprehensive Cancer Center Orange California
United States Children's Hospital of Orange County Orange California
United States Nemours Children's Clinic-Orlando Orlando Florida
United States Walt Disney Memorial Cancer Institute at Florida Hospital Orlando Florida
United States Lucile Packard Children's Hospital at Stanford Palo Alto California
United States Lutheran General Hospital Park Ridge Illinois
United States St. Joseph's Hospital and Medical Center Paterson New Jersey
United States Sacred Heart Children's Hospital Pensacola Florida
United States Saint Jude Midwest Affiliate Peoria Illinois
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States St. Christopher's Hospital for Children Philadelphia Pennsylvania
United States Phoenix Children's Hospital Phoenix Arizona
United States Children's Hospital of Pittsburgh Pittsburgh Pennsylvania
United States Doernbecher Children's Hospital Portland Oregon
United States Legacy Emanuel Hospital and Health Center Portland Oregon
United States Naval Medical Center, Portsmouth Portsmouth Virginia
United States Massey Cancer Center Richmond Virginia
United States Carilion Medical Center for Children Roanoke Virginia
United States James P. Wilmot Cancer Center Rochester New York
United States Mayo Clinic Cancer Center Rochester Minnesota
United States William Beaumont Hospital Royal Oak Michigan
United States Sutter Cancer Center Sacramento California
United States University of California Davis Cancer Center Sacramento California
United States Cardinal Glennon Children's Hospital Saint Louis Missouri
United States St. Louis Children's Hospital Saint Louis Missouri
United States Children's Hospitals and Clinics - Minnesota Saint Paul Minnesota
United States Huntsman Cancer Institute Salt Lake City Utah
United States Methodist Health Care System San Antonio Texas
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Children's Hospital San Diego San Diego California
United States Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego San Diego California
United States Kaiser Permanente Medical Center - San Francisco Geary Campus San Francisco California
United States UCSF Comprehensive Cancer Center San Francisco California
United States Santa Barbara Cottage Hospital Santa Barbara California
United States Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States Maine Children's Cancer Program Scarborough Maine
United States Children's Hospital and Regional Medical Center - Seattle Seattle Washington
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Group Health Cooperative Seattle Washington
United States Avera Cancer Institute Sioux Falls South Dakota
United States Sioux Valley Hospital Sioux Falls South Dakota
United States Deaconess Medical Center Spokane Washington
United States Baystate Medical Center Springfield Massachusetts
United States Southern Illinois University School of Medicine Springfield Illinois
United States All Children's Hospital St. Petersburg Florida
United States State University of New York Health Sciences Center - Stony Brook Stony Brook New York
United States Atlantic Health System Summit New Jersey
United States State University of New York - Upstate Medical University Syracuse New York
United States Madigan Army Medical Center Tacoma Washington
United States Tampa Children's Hospital Tampa Florida
United States Scott and White Memorial Hospital Temple Texas
United States Toledo Children's Hospital Toledo Ohio
United States David Grant Medical Center Travis Air Force Base California
United States Arizona Cancer Center Tucson Arizona
United States Natalie Warren Bryant Cancer Center Tulsa Oklahoma
United States New York Medical College Valhalla New York
United States Children's National Medical Center Washington District of Columbia
United States Lombardi Cancer Center Washington District of Columbia
United States Walter Reed Army Medical Center Washington District of Columbia
United States St. Mary's Hospital West Palm Beach Florida
United States Wesley Medical Center Wichita Kansas
United States Alfred I. Dupont Institute Wilmington Delaware
United States University of Massachusetts Memorial Medical Center - University Campus Worcester Massachusetts
United States Forum Health-Tod Childrens Hospital Youngstown Ohio

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Netherlands,  New Zealand,  Puerto Rico,  Switzerland, 

References & Publications (1)

Langevin AM, Bernstein M, Kuhn JG, Blaney SM, Ivy P, Sun J, Chen Z, Adamson PC; Children's Oncology Group. A phase II trial of rebeccamycin analogue (NSC #655649) in children with solid tumors: a Children's Oncology Group study. Pediatr Blood Cancer. 2008 — View Citation

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