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Home > "P" Clinical Trials Conditions > Phase I Trial of ABT-751 in Children with Solid Tumors  Phase I Trial of ABT-751 in Children with Solid Tumors
Phase I Trial of ABT-751 in Children with Solid Tumors
For Condition: Neoplasms
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will determine the side effects and maximum tolerated dose of the experimental drug ABT-751 that can be safely given to children and young adults with solid tumors. ABT-751 belongs to a new class of anticancer drugs that hamper the replication of cancer cells. It works by binding to a protein called tubulin. Other drugs that work this way include vincristine, vinblastine, vinorelbine, paclitaxel, and docetaxel. In laboratory studies, ABT-751 kills cancer cells that are resistant to vincristine and paclitaxel. Patients up to 18 years of age with solid tumors (rhabdomyosarcoma and other soft tissue sarcomas, Ewing's sarcoma family of tumors, osteosarcoma, neuroblastoma, Wilms' tumor, liver tumors germ cell tumors, primary brain tumors, and other solid tumors) whose disease has relapsed, or whose tumor no longer responds to standard treatment, may be eligible for this study. Candidates will be screened with a history and physical, and neurological examinations, blood and urine tests, echocardiogram (heart ultrasound), and imaging studies to evaluate the extent of disease. Participants will take one ABT-751 capsule a day for 7 days each treatment cycle. A treatment cycle will be 21 to 28 days, depending on how long it takes the patient to recover from the drug side effects. The drug dose will be increased gradually in successive groups of patients if side effects of the previous dose were acceptable. Patients may continue treatment unless their disease worsens with ABT-751 or irreversible side effects occur. They will undergo the following evaluations during this study: - Physical examinations-weekly - Routine blood tests-twice a week - CT or MRI scans to evaluate the size of the tumor-after the first treatment cycle and then after every other cycle - Echocardiogram to evaluate heart structure and function - before starting treatment and then before every even-numbered cycle (cycle 2, 4, 6, and so on) - Blood tests to study how the body handles ABT-751-during the first treatment cycle. For this test, 8 blood samples of one teaspoon or less each will be drawn on the first day of ABT-751 therapy and one blood sample will be drawn on days 2, 5, and 7 before taking the drug. If possible, blood will be collected through a small plastic catheter placed in a vein (heparin lock or Hickman line or port-a-cath) to avoid multiple needle sticks. - Blood test to study the effects of ABT-751 on normal blood cells. For this test, blood samples of 2 teaspoons or less each will be drawn before the first dose of ABT-751, and 6 and 24 hours after the first dose-first treatment cycle only. - 24-hour urine collection-after the first dose of ABT-751 - Magnetic resonance imaging (MRI) with gadolinium contrast to analyze the effect of ABT-751 on blood flow to the tumor. This test will be done only in some patients. It will be done before starting the first treatment cycle and repeated 2 to 3 days after starting treatment. MRI uses a magnetic field and radio waves to show structural and chemical changes in tissues. For the procedure, the patient lies still on a stretcher that is moved into the MRI scanner (a narrow cylinder containing the magnet). Earplugs are worn to muffle loud noises caused by electrical switching of radio frequency circuits used in the scanning process. A gadolinium contrast material is injected to brighten the images.
Details: ABT-751 is a novel, orally-bioavailable sulfonamide antimitotic agent that binds to the colchicine binding site on beta-tubulin and inhibits polymerization of microtubules. ABT-751 demonstrated a broad spectrum of activity in a panel of 30 tumor cell lines in vitro and in xenograft models of human tumors in vivo including those that are paclitaxel, vincristine, and doxorubicin-resistant due to the multidrug-resistant (MDR) phenotype (P-gp overexpression). ABT-751 was most active in a preclinical murine sarcoma model. In vivo data from synergic murine tumor models suggest that continuous dosing of ABT-751 for 21-28 days dramatically enhances anti-tumor efficacy when compared to a 5 day schedule. In a phase I study of oral ABT-751 in adults with solid tumors on a daily x 5 days q 21 days schedule in the maximum allowable dose (MAD) was 240 mg/m(2)/dose. A more recent phase I trial of oral ABT-751 in adults with solid tumors on a daily x 21 day q 28 day schedule is currently testing a dose of 250 mg/ day. Nine patients received 200 mg/day x 21 days and this dose was found to be tolerable. The unique mechanism of action (colchicine beta-tubulin binding site) for an antimitotic agent, broad spectrum of activity in preclinical studies, and oral bioavailability make ABT-751 a potentially important new agent for evaluation in the pediatric population. A pediatric phase I trial of ABT-751 will be performed to determine the toxicity profile, dose-limiting toxicities, maximum tolerated dose (MTD), pharmacokinetics, and pharmacodynamics. ABT-751 will be administered orally on a once daily x 7 days schedule with cycles to be repeated every 21 days and on a once daily x 21 days schedule with cycles to be repeated every 28 days.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: AGE: Patients must be less than or equal to 18 years of age . DIAGNOSIS: Histologically confirmed diagnosis of solid tumors, which may include but are not limited to rhabdomyosarcoma and other soft tissue sarcomas, Ewing's sarcoma family of tumors, osteosarcoma, neuroblastoma, Wilms' tumor, hepatic tumors, germ cell tumors, and primary brain tumors. In patients with brain stem or optic gliomas the requirement for histological confirmation may be waived if a biopsy has not been performed. DISEASE STATUS: Patients must have measurable or evaluable tumors. In patients with neuroblastoma measurable or evaluable tumors is not required because of the demonstration of clinical benefit in previously treated patients with neuroblastoma on this trial. PRIOR THERAPY: The patient's cancer must have relapsed after or failed to respond to frontline standard therapy and there must not be other standard treatment options available. Standard 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, their last dose of chemotherapy at least 30 days prior to study entry (42 days for nitrosoureas), and their last dose of any investigational cancer therapy at least 30 days prior to study entry; Patients must have recovered from the toxic effects of all prior therapy before entry onto this trial; Patients with brain tumors must be on a stable or tapering dose of corticosteroids for 7 days prior to the baseline scan performed for the purpose of assessing response to therapy on this study; Patients should be off colony stimulating factors such as filgrastim (G-CSF), sargramostim (GM-CSF), and IL-11 (with the exception of erythropoietin) for at least 72 hours prior to study entry. PERFORMANCE STATUS: Patients greater than 10 years old must have a Karnofsky performance level greater than 50, and children less than or equal to 10 years old must have a Lansky performance level greater than 50. HEMATOLOGICAL FUNCTION: Patients must have adequate bone marrow function, defined as a peripheral absolute neutrophil count of greater than or equal to 1,500/microL, and a platelet count greater than or equal to 100,000/microL. HEPATIC FUNCTION: Patients must have adequate liver function, defined as bilirubin less than or equal to 1.5 x the upper limit of normal, SGPT (ALT) and SGOT (AST) less than or equal to 2.5 x the upper limit of normal. RENAL FUNCTION: 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). CARDIAC FUNCTION: A normal left ventricular ejection fraction measured by Echocardiogram. INFORMED CONSENT: All patients or their legal guardians (if the patient is less than 18 years old) must sign a document of informed consent (Pediatric Oncology Branch, NCI screening protocol for NIH patients) prior to performing studies to determine patient eligibility. After confirmation of patient eligibility all patients or their legal guardians must voluntarily sign the IRB approved protocol specific informed consent to document their understanding of the investigational nature and the risks of this study before any protocol related studies are performed (other than the studies which were performed to determine patient eligibility). DURABLE POWER OF ATTORNEY (DPA): Patients who have brain tumors and who are 18 years of age will be offered the opportunity to assign a Durable Power of Attorney (DPA) so that another person can make decisions about their medical care if they become incapacitated or cognitively impaired. BIRTH CONTROL: Subjects of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study. EXCLUSION CRITERIA: Clinically significant unrelated systemic illness, such as serious infections, hepatic, renal or other organ dysfunction, which in the judgment of the principal investigator, protocol chairperson or associate investigator would compromise the patient's ability to tolerate the investigational agent or are likely to interfere with the study procedures or endpoints. Patients with a history of bone marrow transplantation or extensive radiotherapy (craniospinal radiation, total body radiation, or radiation to more than half of the pelvis) within the previous 4 months. Pregnant or breast feeding female are excluded. Patients currently receiving other investigational agents. Patients with preexisting grade 2 or greater sensory or motor neuropathy. Patients with CNS tumor who have motor or sensory deficits that would obscure the assessment of sensory neuropathy. Patients with allergy to sulfa containing medications. Patients previously known to be HIV infected are excluded because of the potential suppression of the immune system by ABT-751. Inability to swallow intact capsules.
Total Enrollment: 48
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Wendy Goodspeed 3015944762
Additional Information:
Study ID Numbers: 020141; 02-C-0141
Study Start Date: March 6, 2002
Record last reviewed: February 1, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032266
Other Neoplasms Studies:
1. A Phase II study of carboplatin plus irinotecan versus irinotecan in children with refractory solid tumors
2. Kanglaite Injection Phase I Study
3. A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients with Solid Tumors
4. Intrathecal Gemcitibine to Treat Neoplastic Meningitis
5. Anemia in Patients with a Non-Myeloid Malignancy
Related Studies:
Other Neoplasms Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Phase I Trial of ABT-751 in Children with Solid Tumors
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