- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00019630
Liposomal Doxorubicin in Treating Children With Refractory Solid Tumors
Phase I Study of Doxorubicin HCl Liposome in Pediatric Patients With Refractory Solid Tumors
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
PROJECTED ACCRUAL:
A total of 21-36 patients will be accrued for this study within 1-2 years.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- Pediatric Oncology Branch
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
PROTOCOL ENTRY CRITERIA:
--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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Elizabeth Lowe, National Cancer Institute (NCI)
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- unspecified childhood solid tumor, protocol specific
- cancer
- osteosarcoma
- adult solid tumor
- solid tumor
- brain tumor
- neuroblastoma
- gastrointestinal cancer
- body system/site cancer
- kidney tumor
- kidney/urinary cancer
- bone cancer
- childhood cancer
- previously treated childhood rhabdomyosarcoma
- recurrent childhood rhabdomyosarcoma
- recurrent neuroblastoma
- recurrent osteosarcoma
- childhood oligodendroglioma
- recurrent childhood cerebellar astrocytoma
- recurrent childhood cerebral astrocytoma
- recurrent childhood ependymoma
- childhood brain tumor
- recurrent childhood brain tumor
- childhood liver cancer
- recurrent childhood liver cancer
- childhood soft tissue sarcoma
- recurrent childhood soft tissue sarcoma
- recurrent childhood brain stem glioma
- recurrent childhood medulloblastoma
- recurrent childhood visual pathway and hypothalamic glioma
- childhood craniopharyngioma
- childhood central nervous system germ cell tumor
- childhood choroid plexus tumor
- childhood malignant testicular germ cell tumor
- childhood malignant ovarian germ cell tumor
- recurrent childhood malignant germ cell tumor
- genetic condition
- Wilms' tumor
- liver and intrahepatic biliary tract cancer
- childhood extracranial germ cell tumor
- childhood ependymoma
- childhood meningioma
- childhood medulloblastoma
- childhood cerebellar astrocytoma
- childhood brain stem glioma
- Ewing's family of tumors
- central nervous system cancer
- childhood cerebral astrocytoma
- childhood extragonadal malignant germ cell tumor
- childhood mature and immature teratomas
- childhood rhabdomyosarcoma
- childhood solid tumor
- childhood supratentorial primitive neuroectodermal and pineal tumors
- childhood visual pathway and hypothalamic glioma
- endocrine cancer
- muscle cancer
- musculoskeletal cancer
- osteosarcoma/malignant fibrous histiocytoma of bone
- pediatric germ cell tumor
- recurrent Wilms' tumor
- recurrent childhood supratentorial primitive neuroectodermal and pineal tumors
- recurrent tumors of the Ewing's family
- stage, Ewing's family of tumors
- stage, Wilms' tumor
- stage, childhood extracranial germ cell tumor
- stage, childhood liver cancer
- stage, childhood medulloblastoma
- stage, childhood rhabdomyosarcoma
- stage, childhood soft tissue sarcoma
- stage, neuroblastoma
- stage, osteosarcoma
- stage/type, childhood brain tumor
Additional Relevant MeSH Terms
- Digestive System Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Digestive System Neoplasms
- Liver Diseases
- Musculoskeletal Diseases
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Bone Diseases
- Neoplasms, Bone Tissue
- Neoplasms, Connective Tissue
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Neoplasms
- Sarcoma
- Kidney Neoplasms
- Bone Neoplasms
- Brain Neoplasms
- Liver Neoplasms
- Osteosarcoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Doxorubicin
- Liposomal doxorubicin
Other Study ID Numbers
- CDR0000066924
- NCI-99-C-0039F
- LIPO-NCI-99-C-0039
- NCI-99-C-0039
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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