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Trial record 14 of 23 for:    "Undifferentiated Pleomorphic Sarcoma" | "Antibiotics, Antitubercular"

Liposomal Doxorubicin in Treating Children With Refractory Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00019630
Recruitment Status : Completed
First Posted : March 5, 2007
Last Update Posted : April 28, 2015
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of liposomal doxorubicin in treating children who have refractory solid tumors.

Condition or disease Intervention/treatment Phase
Childhood Soft Tissue Sarcoma Childhood Liver Cancer Bone Cancer Brain Tumor Kidney Tumor Drug: doxorubicin HCl liposome Phase 1

Detailed Description:

OBJECTIVES: I. Determine the tolerance to and toxicity profile of doxorubicin HCl liposome (Lipodox) at standard doxorubicin doses and doses of Lipodox that were tolerable in adults administered every 3 weeks in pediatric patients with refractory solid tumors.

II. Determine the maximum tolerated dose of this drug in these patients if dose-limiting toxicity is observed at doses of 105 mg/m2 or less.

III. Determine the pharmacokinetics of this drug in these patients. IV. Assess the cardiotoxicity of this drug in children who have previously been treated with free doxorubicin and in children who have not previously received doxorubicin.

V. Evaluate the feasibility of using cardiac MRI functional imaging as a screening tool for the quantitative assessment of doxorubicin-induced cardiotoxicity.

VI. Determine if serum troponin t levels are a useful biomarker for doxorubicin-induced myocardial damage.

PROTOCOL OUTLINE: This is a dose-escalation, multicenter study. Patients receive doxorubicin HCl liposome IV over 60 minutes. Treatment repeats every 4 weeks for a maximum of 10 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 4-6 patients receive escalating doses of doxorubicin HCl liposome until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 4 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.


A total of 21-36 patients will be accrued for this study within 1-2 years.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I Study of Doxorubicin HCl Liposome in Pediatric Patients With Refractory Solid Tumors
Study Start Date : July 1999

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)


--Disease Characteristics-- Histologically confirmed solid tumor, including but not limited to: Rhabdomyosarcoma and other soft tissue sarcomas Ewing's family tumors Osteosarcoma Neuroblastoma Wilms' tumor Hepatic tumors Germ cell tumors Primary brain tumors Histological confirmation for brain stem gliomas may be waived Refractory to standard treatment and no curative therapy available Measurable or evaluable disease Evidence of progressive disease on prior chemotherapy or radiotherapy or persistent disease after prior surgery --Prior/Concurrent Therapy-- Biologic therapy: At least 1 week since prior colony-stimulating factors (e.g., filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa) At least 4 months since prior bone marrow transplantation No concurrent anticancer immunotherapy Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (4 weeks for nitrosoureas) and recovered Prior anthracyclines as adjuvant front-line therapy allowed provided: No relapse during therapy At least 6 months since last dose Cumulative dose is no greater than 400 mg/m2 for patients who received bolus administration without a concurrent cardioprotectant (e.g., dexrazoxane) or received cardiac irradiation and no greater than 450 mg/m2 for patients who received either continuous infusion or administration with a concurrent cardioprotectant and have not received cardiac irradiation No other concurrent anticancer chemotherapy Endocrine therapy: Concurrent corticosteroids for brain tumor-associated edema allowed (must be on stable or decreasing dose for at least 1 week prior to study) Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No more than 1,500 cGy of prior cardiac radiotherapy No prior extensive radiotherapy (e.g., craniospinal radiation, total body radiation, or radiation to more than half of the pelvis) No concurrent anticancer radiotherapy Surgery: See Disease Characteristics Other: No other concurrent anticancer investigational agents No other concurrent liposomal formulations of any drug (e.g., liposomal amphotericin B) --Patient Characteristics-- Age: 21 and under Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: Absolute granulocyte count greater than 1,500/mm3 Hemoglobin greater than 8 g/dL Platelet count greater than 100,000/mm3 Hepatic: Bilirubin normal SGPT no greater than 2 times upper limit of normal No significant hepatic dysfunction Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular: Cardiac ejection fraction at least 45% on MUGA (National Cancer Institute patients) OR Shortening fraction at least 28% on echocardiogram (Children's Hospital of Philadelphia patients) No significant or preexisting cardiac dysfunction (e.g., recurrent or persistent cardiac dysrhythmia or an ejection fraction below the lower limit of normal on MUGA or echocardiogram) Pulmonary: No significant pulmonary dysfunction Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No clinically significant unrelated systemic illness (e.g., serious infections or organ dysfunction) No allergy to doxorubicin or other anthracyclines, eggs, egg products, or other liposomal drug formulations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00019630

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United States, Maryland
Pediatric Oncology Branch
Bethesda, Maryland, United States, 20892
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
National Cancer Institute (NCI)
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Study Chair: Elizabeth Lowe National Cancer Institute (NCI)

Layout table for additonal information Identifier: NCT00019630     History of Changes
Obsolete Identifiers: NCT00001798
Other Study ID Numbers: CDR0000066924
First Posted: March 5, 2007    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: June 2002
Keywords provided by National Cancer Institute (NCI):
osteosarcoma/malignant fibrous histiocytoma of bone
Ewing's family of tumors
Wilms' tumor
adult solid tumor
body system/site cancer
bone cancer
brain tumor
central nervous system cancer
childhood brain stem glioma
childhood brain tumor
childhood cancer
childhood central nervous system germ cell tumor
childhood cerebellar astrocytoma
childhood cerebral astrocytoma
childhood choroid plexus tumor
childhood craniopharyngioma
childhood ependymoma
childhood extracranial germ cell tumor
childhood extragonadal malignant germ cell tumor
childhood liver cancer
childhood malignant ovarian germ cell tumor
childhood malignant testicular germ cell tumor
childhood mature and immature teratomas
childhood medulloblastoma
childhood meningioma
childhood oligodendroglioma
childhood rhabdomyosarcoma
childhood soft tissue sarcoma
childhood solid tumor
Additional relevant MeSH terms:
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Antibiotics, Antineoplastic
Brain Neoplasms
Liver Neoplasms
Kidney Neoplasms
Bone Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Bone Diseases
Musculoskeletal Diseases
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Liposomal doxorubicin
Antineoplastic Agents