Tirapazamine Plus Cyclophosphamide in Treating Children With Refractory Solid Tumors

NCT00003288 | Completed Phase 1

• 3 other identifiers: NCI-2012-01837POG-9675CDR0000066219
• Study Type: interventional
• Target: 12
• Locations: 2 countries
• Sites: 28

Brief Summary

Phase I trial to study the effectiveness of tirapazamine plus cyclophosphamide in treating children who have refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

Conditions

Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

unspecified childhood solid tumor, protocol specific

Study Arms (1)

Arm I

EXPERIMENTAL

See arm description.

Biological: filgrastim; Drug: cyclophosphamide; Drug: tirapazamine

Interventions

filgrastim BIOLOGICAL

Arm I

cyclophosphamide DRUG

Arm I

tirapazamine DRUG

Arm I

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor that is refractory to conventional therapy or for which no effective therapy is known * Brain tumors eligible Brainstem gliomas may waive histological verification requirement * Neurologic deficits associated with CNS malignancies must be stable for a minimum of 4 weeks prior to study * No leukemia Stratum 2 * No marrow involvement PATIENT CHARACTERISTICS: * Age: 21 and under * Performance status: Karnofsky or Lansky 50-100% * Life expectancy: At least 8 weeks * Absolute neutrophil count at least 1,000/mm3 * Platelet count at least 75,000/mm3 * Hemoglobin at least 9 g/dL * Bilirubin less than 1.5 mg/dL * SGPT less than 5 times normal * Creatinine normal for age OR creatinine clearance at least 70 mL/min * Shortening fraction at least 27% of normal OR ejection fraction greater than 50% of normal * Not pregnant or nursing * Negative pregnancy test required PRIOR CONCURRENT THERAPY: * No concurrent anticancer therapy * At least 6 months since bone marrow transplant and no evidence of graft versus host disease * At least 1 week since growth factors * No concurrent granulocyte colony-stimulating factor * Recovered from prior immunotherapy * Stratum 2: No prior bone marrow transplantation (with or without total body irradiation) * At least 6 weeks since prior nitrosourea * At least 2 weeks since other prior myelosuppressive chemotherapy * Dexamethasone must be a stable or decreasing dose for 2 weeks prior to study * Recovered from prior chemotherapy * Stratum 2: No more than 2 prior chemotherapy regimens * At least 2 weeks since local palliative radiotherapy (small port) * At least 6 months since prior substantial bone marrow radiation (e.g., cross- sectional radiotherapy \[greater than 24 Gy\], total body irradiation, hemi- pelvic radiotherapy) * Recovered from prior radiotherapy * Stratum 2: No prior central axis radiation

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (28)

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

University of California San Diego Cancer Center

La Jolla, California, 92093-0658, United States

Location

Lucile Packard Children's Hospital at Stanford

Palo Alto, California, 94304, United States

Location

Sylvester Cancer Center, University of Miami

Miami, Florida, 33136, United States

Location

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

Children's Memorial Hospital, Chicago

Chicago, Illinois, 60614, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

Johns Hopkins Oncology Center

Baltimore, Maryland, 21287, United States

Location

Floating Hospital for Children

Boston, Massachusetts, 02111, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Cardinal Glennon Children's Hospital

St Louis, Missouri, 63104, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

State University of New York - Upstate Medical University

Syracuse, New York, 13210, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Saint Jude Children's Research Hospital

Memphis, Tennessee, 38105-2794, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

Cook Children's Medical Center - Fort Worth

Fort Worth, Texas, 76104, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284, United States

Location

Midwest Children's Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Montreal Children's Hospital

Montreal, Quebec, H3H 1P3, Canada

Location

Hopital Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

Location

MeSH Terms

Interventions

Filgrastim; Cyclophosphamide; Tirapazamine

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Victor Aquino, MD

  Simmons Cancer Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: September 13, 2004
• Study Start: August 1, 1998
• Primary Completion: June 1, 2003
• Last Updated: February 5, 2013

Record last verified: 2000-04

Locations

US (25); CA (3)