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Home > "D" Clinical Trials Conditions > Depsipeptide to Treat Thyroid and Other Advanced Cancers  Depsipeptide to Treat Thyroid and Other Advanced Cancers
Depsipeptide to Treat Thyroid and Other Advanced Cancers
For Condition: Neoplasms
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This phase I study will evaluate the experimental drug depsipeptide in patients with advanced cancer. The study will: -Determine the ability of patients to tolerate treatment with depsipeptide. -Measure blood levels of depsipeptide at certain time points during treatment. -Analyze the cellular and molecular effects of the drug. -Determine if depsipeptide can shrink tumors. Depsipeptide is a new drug that has been shown to kill cancer cells in the test tube and in animals with various types of tumors. In preliminary studies with more than 100 patients, several patients with a type of lymphoma and one patient with kidney cancer responded to treatment. Patients 18 years of age and older with advanced cancer (excluding acute leukemia) may be eligible for this study. Candidates will be screened with a medical history and physical examination, X-rays and CT scans to determine the extent of disease, and blood tests and urine tests. Patients with thyroid cancer may also have magnetic resonance imaging (MRI). Participants will receive three infusions of depsipeptide during each 21-day treatment cycle. The infusions are given through a vein (IV) over 4 hours on cycle days 1, 3 and 5. The IV tube may be a peripheral line in the arm or a central line, in which the tube is placed under the skin of the chest or neck into a major vein. Patients are hospitalized for the first 6 days of the first cycle to monitor heart rate. Those who tolerate the treatment well may continue as an outpatient. In addition to drug therapy, participants undergo the following procedures: -Blood tests: A small amount of blood is drawn frequently during the first 5 days of treatment to measure depsipeptide levels and to see how the body uses and excretes the drug. A heparin lock (an indwelling device to keep the vein open) may be put in the vein to prevent the need for repeated needlesticks. -Biopsies (removal of a small sample of tumor tissue): Tumors that are accessible will be biopsied at the start of the study and at different times during treatment. They will be examined for the effects of depsipeptide on proteins that control cell division. -Scans and X-rays: Imaging studies are usually done before starting treatment, some are repeated at every 2 cycles (6 weeks), and some are repeated at the end of the patient's participation in the study. These may include chest X-rays, plain X-rays of affected bones, CT scans of the chest, abdomen, and pelvis, a bone scan, and other scans as needed. Patients with thyroid cancer also undergo radioiodide whole body scan and possibly bone scans, octreotide scans, Sestamibi scans or PET scans. The Sestamibi and PET scans involve injecting a radioactive substance that is detected by a special camera during scanning to detect cancer cells. A MUGA scan (special X-ray of the heart) or echocardiogram (ultrasound of the heart) is done to test heart function before and during the study. -Other tests include an electrocardiogram, or ECG (recording of the electrical activity of the heart) before and after each dose of depsipeptide. Eye exams will be performed if there are vision changes or if the doctor recommends an eye test. Treatment will continue until it is no longer effective, at which time other alternatives will be discussed with the patient.
Details: NSC 630176, FR901228, is a depsipeptide isolated from Chromobacterium violaceum by the Fujisawa Company (1). It has demonstrated potent cytotoxic activity against human tumor cell lines and in vivo efficacy against both human tumor xenografts and murine tumors (2, 3). NSC 630176, herein referred to as depsipeptide, shows a lack of cross resistance with several commonly used cytotoxic agents such as vincristine, 5-fluorouracil, mitomycin C and cyclophosphamide (2). However, it has been defined as a P-glycoprotein (Pgp) substrate by COMPARE analysis of the NCI drug screen cytotoxicity profile (4). Depsipeptide is a member of a novel class of antineoplastic agents, the histamine deacetylase inhibitors (HDIs). A phase I trial of depsipeptide was completed at the NCI. The drug was given in a 4-hour infusion on days 1 and 5 of a 21-day cycle. The MTD was found to be 17.8 mg/m(2). The dose limiting toxicities were grade 3 fatigue, grade 3 nausea and vomiting and grade 4 thrombocytopenia. Other observed toxicities include hypocalcemia, granulocytopenia and reversible ST-T wave changes that were not associated with detectable myocardial damage or change in cardiac function. In that trial, several patients with cutaneous T-cell lymphoma had a complete response. A phase II study was initiated to evaluate the rate of response of patients with these specific types of lymphomas. Clinical trials of histone deacetylase inhibitors allow for the use of surrogate markers of biological activity. In addition, these agents may be used to induce the expression of targets of other anti-neoplastic agents. Since laboratory studies suggest that longer exposure to non-toxic doses of depsipeptide can enhance its molecular effects to a greater degree than short toxic doses that rapidly cause cell death, we plan to examine the effect of a multi-day regimen of depsipeptide on surrogate markers and the expression of molecular targets. We are initiating a new phase I trial to administer depsipeptide on days 1, 3 and 5. The goals of this trial are: To determine the MTD of depsipeptide when administered on days 1, 3 and 5. To examine the effect of a multi-day regimen of depsipeptide on surrogate markers and the expression of molecular targets. To determine whether thyroid cancers that do not have detectable uptake of RAI will have detectable uptake after treatment.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA Patients must have histologic or cytologic confirmation of cancer (excluding acute leukemia) for which there is no known standard therapy capable of extending life expectancy. Patients must: -be greater than or equal to18 years of age. -have evaluable disease. -have a performance status of ECOG 0-2. -have no serious or intercurrent illness that can not be medically controlled and have a life expectancy of greater than 12 weeks. -give written informed consent. -be willing to return to the National Cancer Institute for follow-up. -female patients of childbearing potential must have a negative pregnancy test within 1 week and must use effective contraception (hormonal or barrier methods) while being treated on protocol. Laboratory values: -within 7 days prior to registration: absolute neutrophil count greater than or equal to 1000/microL, platelets greater than or equal to 100,000/microL, bilirubin (total and direct) less than or equal to 1.5x upper limit of normal, and AST less than or equal to 3x upper limit of normal, creatinine less than or equal to 1.5x upper limit of normal or documented creatinine clearance of greater than or equal to 60 mL/min. -within 4 weeks of registration: ejection fraction within normal as determined by echocardiogram, MUGA scan, or cardiac MRI. Criteria for cohort of patients with RAI refractory non-medullary thyroid cancer to be enrolled after the MTD has been defined: -non-medullary thyroid carcinoma. -progressive disease following total or near-total thyroidectomy and RAI therapy. -documented evidence of no, or minimally (faint), RAI uptake on RAI whole body scan. -no RAI therapy within 3 months prior to study entry. -no history of administration of IV iodinated contrast or other large iodine loads (i.e. CT, amiodarone, SSKI) during the previous 6 months. -24 hr. urinary iodine values less than or equal to 70 micrograms/day EXCLUSION CRITERIA: Patients with unconfirmed diagnosis will be excluded. Prior or concurrent malignancies that have not been curatively treated. Current or previous CNS metastasis. Chemotherapy within 4 weeks, 6 weeks for nitrosoureas or mitomycin C, and 8 weeks for UCN-01. HIV seropositivity Pregnant or breast-feeding patients Uncontrolled infection Patients with MI within previous 6 months, EF below normal, QTc greater than 500 ms, or unstable angina. Patients with other cardiac disease will be considered for study following consultation with cardiology.
Total Enrollment: 56
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030030; 03-C-0030
Study Start Date: October 26, 2002
Record last reviewed: September 9, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00048334
Other Neoplasms Studies:
1. MG98 in Treating Patients With Advanced Solid Tumors
2. Phase I Study of HeFi-1 to Treat Cancers with CD30 Protein
3. A Phase II study of carboplatin plus irinotecan versus irinotecan in children with refractory solid tumors
4. Liposome Encapsulated SN38 (LE-SN38) in Patients with Advanced Cancer
5. A Trial to Evaluate Epothilone D in Patients with Advanced Solid Tumors
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Depsipeptide to Treat Thyroid and Other Advanced Cancers
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