Liposomal Doxorubicin in Treating Children With Refractory Solid Tumors

NCT00019630 | Completed Phase 1

• 4 other identifiers: CDR0000066924NCI-99-C-0039FLIPO-NCI-99-C-0039NCI-99-C-0039
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

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; 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

Interventions

doxorubicin HCl liposome DRUG

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)

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

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 (2)

Pediatric Oncology Branch

Bethesda, Maryland, 20892, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Bone Neoplasms; Brain Neoplasms; Carcinoma, Renal Cell; Neuroectodermal Tumors, Primitive, Peripheral; Wilms Tumor; Neoplasms; Central Nervous System Neoplasms; Astrocytoma; Choroid Plexus Neoplasms; Familial ependymoma; Ovarian Germ Cell Cancer; Testicular Neoplasms; Teratoma; Medulloblastoma; Meningioma; Oligodendroglioma; Pinealoma; Optic Nerve Glioma; Endocrine Gland Neoplasms; Gastrointestinal Neoplasms; Genetic Diseases, Inborn; Urologic Neoplasms; Carcinoma, Hepatocellular; Muscle Neoplasms; Neuroblastoma; Osteosarcoma; Histiocytoma, Malignant Fibrous

Condition Hierarchy (Ancestors)

Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neoplasms, Complex and Mixed; Neoplastic Syndromes, Hereditary; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Glioma; Cerebral Ventricle Neoplasms; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Optic Nerve Neoplasms; Cranial Nerve Neoplasms; Peripheral Nervous System Neoplasms; Cranial Nerve Diseases; Optic Nerve Diseases; Eye Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Liver Neoplasms; Liver Diseases; Soft Tissue Neoplasms; Muscular Diseases; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Sarcoma; Histiocytoma; Neoplasms, Fibrous Tissue

Study Officials

• Elizabeth Lowe

  National Cancer Institute (NCI)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 1, 2007
• First Posted: March 5, 2007
• Study Start: July 1, 1999
• Last Updated: March 4, 2024

Record last verified: 2024-03

Locations

US (2)