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Phase I Trial and Pharmacokinetic Study of TLC D-99 in Pediatric Patients with Refractory Solid Tumors Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Phase I Trial and Pharmacokinetic Study of TLC D-99 in Pediatric Patients with Refractory Solid Tumors conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Phase I Trial and Pharmacokinetic Study of TLC D-99 in Pediatric Patients with Refractory Solid Tumors Clinical research trials and Phase I Trial and Pharmacokinetic Study of TLC D-99 in Pediatric Patients with Refractory Solid Tumors health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Phase I Trial and Pharmacokinetic Study of TLC D-99 in Pediatric Patients with Refractory Solid Tumors. Phase I Trial and Pharmacokinetic Study of TLC D-99 in Pediatric Patients with Refractory Solid Tumors Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Phase I Trial and Pharmacokinetic Study of TLC D-99 in Pediatric Patients with Refractory Solid Tumors clinical trial. Participants oftentimes recieve the most expert healthcare available for their Phase I Trial and Pharmacokinetic Study of TLC D-99 in Pediatric Patients with Refractory Solid Tumors condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase I Trial and Pharmacokinetic Study of TLC D-99 in Pediatric Patients with Refractory Solid Tumors  Phase I Trial and Pharmacokinetic Study of TLC D-99 in Pediatric Patients with Refractory Solid Tumors
Phase I Trial and Pharmacokinetic Study of TLC D-99 in Pediatric Patients with Refractory Solid Tumors
For Condition: Glioma,Neoplasm,Nephroblastoma,Neuroblastoma,Rhabdomyosarcoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Doxorubicin is one of the most effective and most widely used chemotherapeutic agents in the treatment of childhood cancers. Its broad spectrum of activity includes both hematological malignancies and solid tumors. However, its clinical usefulness is limited by the development of doxorubicin-induced cardiotoxicity, which is related to the cumulative dose of the drug, and children are at higher risk for this cardiotoxicity than are adults. Encapsulation of doxorubicin within liposomes reduces its acute and chronic toxicities, including cardiotoxicity. TLC D-99 is a liposomal formulation of doxorubicin in egg phosphatidylcholine/cholesterol liposomes. Fifteen phase I and phase II clinical trials of TLC D-99 have been conducted in over 400 adults, and 3 randomized phase III trials in women with breast cancer are ongoing (overall more than 700 adults have been treated with TLC D-99). Acute toxicity was less than would have been expected, even at higher than standard doses. A phase I trial and pharmacokinetic study of this liposome encapsulated formulation of doxorubicin will be conducted in children, to assess the drug's spectrum of toxicity at standard doses of doxorubicin and at doses of TLC D-99 that were tolerable in adults.
Details: Doxorubicin is one of the most effective and most widely used chemotherapeutic agents in the treatment of childhood cancers. Its broad spectrum of activity includes both hematological malignancies and solid tumors. However, its clinical usefulness is limited by the development of doxorubicin-induced cardiotoxicity, which is related to the cumulative dose of the drug, and children are at higher risk for this cardiotoxicity than are adults. Encapsulation of doxorubicin within liposomes reduces its acute and chronic toxicities, including cardiotoxicity. TLC D-99 is a liposomal formulation of doxorubicin in egg phosphatidylcholine/cholesterol liposomes. Fifteen phase I and phase II clinical trials of TLC D-99 have been conducted in over 400 adults, and 3 randomized phase III trials in women with breast cancer are ongoing (overall more than 700 adults have been treated with TLC D-99). Acute toxicity was less than would have been expected, even at higher than standard doses. A phase I trial and pharmacokinetic study of this liposome encapsulated formulation of doxorubicin will be conducted in children, to assess the drug's spectrum of toxicity at standard doses of doxorubicin and at doses of TLC D-99 that were tolerable in adults.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA Patients must be less than or equal to 21 years of age. Patients must have a histologically confirmed solid tumor, which may include, but are not limited to, rhabdomyosarcoma and other soft tissue sarcomas, Ewing's family tumors, osteosarcoma, neuroblastoma, Wilms' tumor, hepatic tumors, germ cell tumors, and primary brain tumors. For patients with brainstem gliomas the requirement for histological confirmation may be waived. The patient's tumors must be refractory to standard treatment. Patients must have no known potentially curative therapy available to them. Curative therapy may include surgery, radiation therapy, chemotherapy, or any combination of these modalities. Patients must have had their last dose of radiation therapy at least four weeks prior to study entry, and their last dose of chemotherapy at least three weeks prior to study entry (four weeks for nitrosoureas). Patients will be eligible for this study if they have received prior therapy with anthracyclines as adjuvant front line therapy, provided that: The patient did not relapse while receiving the anthracycline; That the last anthracycline dose was at least six months prior to enrollment on this study; And the lifetime cumulative dose of anthracycline is less than or equal to 400 mg/m(2) for those patients who received bolus administration without a cardioprotectant concurrently (e.g., dexrazoxane) OR had cardiac radiation and less than or equal to 450 mg/m(2) for those patients who received their anthracycline by continuous infusion or with a cardioprotectant concurrently and have not had cardiac radiation. Patients must have recovered from the toxic effects of all prior therapy before entry onto this trial. Patients with brain tumors who are receiving corticosteroids for the control of tumor-associated edema must be on a stable, or decreasing dose for at least 1 week prior to study enrollment. Patients should be off colony stimulating factors such as G-CSF, GM-CSF, and Epo for at least one week prior to study entry. Patients must have measurable or evaluable disease. There must be evidence of progressive disease on prior chemotherapy or radiation therapy or persistent disease after surgery. Patients should have an ECOG performance status of 0, 1, or 2 and a life expectancy of at least eight (8) weeks. Patients who are unable to walk because of paralysis, but who are up in a wheel chair will be considered ambulatory for the purpose of calculating the performance score. Patients must have adequate bone marrow function defined as a peripheral absolute granulocyte count of greater than 1500/mm(3), hemoglobin greater than 8 gm/dL, and platelet count greater than 100,000/mm(3). Patients must have adequate liver function, defined as bilirubin within normal limits and SGPT less than or equal to 2 times the upper limit of normal. Patients must have an age-adjusted normal serum creatinine OR a creatinine clearance greater than or equal to 60 mL/min/1.73 m(2). Patients must have normal cardiac ejection fraction (greater than or equal to 45%) on MUGA (NCI patients) or a normal shortening fraction (greater than or equal to 28%) on echocardiogram (CHOP patients). A Durable Power of Attorney is required of all patients 18 to 21 years of age who have a brain tumor. All patients or their legal guardians (if the patient is less than 18 years old) must sign a document of informed consent indicating their understanding of the investigational nature and the risks of this study BEFORE any protocol related studies are performed (this does not include routine laboratory tests or imaging studies required to establish eligibility). When appropriate, pediatric patients will be included in all discussion in order to obtain verbal assent. EXCLUSION CRITERIA Preexisting cardiac dysfunction, defined as a recurrent or persistent cardiac dysrhythmia or an ejection fraction (echocardiogram or MUGA scan) that is below the lower limit of normal. More than 1,500 cGy of prior cardiac radiotherapy. Patients with a history of bone marrow transplantation within the previous 4 months or extensive radiotherapy (craniospinal radiation, total body radiation, or radiation to more than half of the pelvis). Clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction) which in the judgment of the Principal or Associate Investigator would compromise the patient's ability to tolerate TLC D-99 or are likely to interfere with the study procedures or results. Females must not be pregnant or breast feeding. Patients must not be currently receiving other investigational agents. Patients must not currently be treated with other liposomal formulations of any drug. Patients must not have a history of allergy to doxorubicin or other anthracyclines, eggs or egg products or other liposomal drug formulations.
Total Enrollment: 36
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 990039; 99-C-0039
Study Start Date: February 11, 1999
Record last reviewed: June 12, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001798
Other Neuroblastoma Studies:
1. SU5416 to Treat Recurrent Brain Tumors
2. Natural History of Patients with Brain and Spinal Cord Tumors
3. A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas
4. A Phase II Trial of Intravenous Cereport ® (Registered Trademark) (RMP-7) and Carboplatin in Childhood Brain Tumors
5. A Phase I Trial of CC-8490 for the Treatment of Patients with Recurrent/Refractory High-Grade Gliomas
Related Studies:
Other Neuroblastoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Phase I Trial and Pharmacokinetic Study of TLC D-99 in Pediatric Patients with Refractory Solid Tumors
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