Liposomal Doxorubicin in Treating Children With Refractor... | NCT00019630 | Trialant
NCT00019630
Sponsor
National Cancer Institute (NCI)
Status
Completed
Last Update Posted
Mar 4, 2024Actual
Enrollment
Not provided
Phase
Phase 1
Conditions
Childhood Soft Tissue Sarcoma
Childhood Liver Cancer
Bone Cancer
Brain Tumor
Kidney Tumor
Interventions
doxorubicin HCl liposome
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00019630
Obsolete or Duplicate NCT IDs
NCT00001798
Organization Study
CDR0000066924
Secondary IDs
ID
Type
Description
Link
NCI-99-C-0039F
LIPO-NCI-99-C-0039
NCI-99-C-0039
Brief Title
Liposomal Doxorubicin in Treating Children With Refractory Solid Tumors
Official Title
Phase I Study of Doxorubicin HCl Liposome in Pediatric Patients With Refractory Solid Tumors
Acronym
Not provided
Organization
National Cancer Institute (NCI)NIH
Status Module
Record Verification Date
Mar 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 1999
Primary Completion Date
Not provided
Completion Date
Not provided
First Submitted Date
Mar 1, 2007
First Submission Date that Met QC Criteria
Mar 1, 2007
First Posted Date
Mar 5, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 1, 2024
Last Update Posted Date
Mar 4, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
National Cancer Institute (NCI)NIH
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
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.
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.
Conditions Module
Conditions
Childhood Soft Tissue Sarcoma
Childhood Liver Cancer
Bone Cancer
Brain Tumor
Kidney Tumor
Keywords
Ewing's family of tumors
Wilms' tumor
adult solid tumor
body system/site cancer
bone cancer
brain tumor
cancer
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
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
Not provided
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
doxorubicin HCl liposome
Drug
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility Criteria
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
Accepts Healthy Volunteers
Not provided
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
Not provided
Maximum Age
21 Years
Standard Ages
ChildAdult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Elizabeth Lowe
National Cancer Institute (NCI)
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Pediatric Oncology Branch
Bethesda
Maryland
20892
United States
Children's Hospital of Philadelphia
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D001859
Bone Neoplasms
D001932
Brain Neoplasms
D002292
Carcinoma, Renal Cell
D018241
Neuroectodermal Tumors, Primitive, Peripheral
D009396
Wilms Tumor
D009369
Neoplasms
D016543
Central Nervous System Neoplasms
D001254
Astrocytoma
D016545
Choroid Plexus Neoplasms
C531673
Familial ependymoma
C562841
Ovarian Germ Cell Cancer
D013736
Testicular Neoplasms
D013724
Teratoma
D008527
Medulloblastoma
D008579
Meningioma
D009837
Oligodendroglioma
D010871
Pinealoma
D020339
Optic Nerve Glioma
Ancestor Terms
ID
Term
D009371
Neoplasms by Site
D001847
Bone Diseases
D009140
Musculoskeletal Diseases
D009423
Nervous System Neoplasms
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
No data available
No data is available for this block.
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
childhood supratentorial primitive neuroectodermal and pineal tumors
childhood visual pathway and hypothalamic glioma
endocrine cancer
gastrointestinal cancer
genetic condition
kidney tumor
kidney/urinary cancer
liver and intrahepatic biliary tract cancer
muscle cancer
musculoskeletal cancer
neuroblastoma
osteosarcoma
osteosarcoma/malignant fibrous histiocytoma of bone
pediatric germ cell tumor
previously treated childhood rhabdomyosarcoma
recurrent Wilms' tumor
recurrent childhood brain stem glioma
recurrent childhood brain tumor
recurrent childhood cerebellar astrocytoma
recurrent childhood cerebral astrocytoma
recurrent childhood ependymoma
recurrent childhood liver cancer
recurrent childhood malignant germ cell tumor
recurrent childhood medulloblastoma
recurrent childhood rhabdomyosarcoma
recurrent childhood soft tissue sarcoma
recurrent childhood supratentorial primitive neuroectodermal and pineal tumors
recurrent childhood visual pathway and hypothalamic glioma
recurrent neuroblastoma
recurrent osteosarcoma
recurrent tumors of the Ewing's family
solid tumor
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
unspecified childhood solid tumor, protocol specific
Not provided
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
No data available
No data is available for this block.
Philadelphia
Pennsylvania
19104
United States
D004701
Endocrine Gland Neoplasms
D005770
Gastrointestinal Neoplasms
D030342
Genetic Diseases, Inborn
D014571
Urologic Neoplasms
D006528
Carcinoma, Hepatocellular
D019042
Muscle Neoplasms
D009447
Neuroblastoma
D012516
Osteosarcoma
D051677
Histiocytoma, Malignant Fibrous
D001927
Brain Diseases
D002493
Central Nervous System Diseases
D009422
Nervous System Diseases
D000230
Adenocarcinoma
D002277
Carcinoma
D009375
Neoplasms, Glandular and Epithelial
D009370
Neoplasms by Histologic Type
D007680
Kidney Neoplasms
D014565
Urogenital Neoplasms
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D007674
Kidney Diseases
D014570
Urologic Diseases
D052801
Male Urogenital Diseases
D018242
Neuroectodermal Tumors, Primitive
D018302
Neoplasms, Neuroepithelial
D017599
Neuroectodermal Tumors
D009373
Neoplasms, Germ Cell and Embryonal
D009380
Neoplasms, Nerve Tissue
D018193
Neoplasms, Complex and Mixed
D009386
Neoplastic Syndromes, Hereditary
D009358
Congenital, Hereditary, and Neonatal Diseases and Abnormalities