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A Study of NM-3 Administered Orally in Patients with Advanced Solid Tumors. Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on A Study of NM-3 Administered Orally in Patients with Advanced Solid Tumors. conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. A Study of NM-3 Administered Orally in Patients with Advanced Solid Tumors. Clinical research trials and A Study of NM-3 Administered Orally in Patients with Advanced Solid Tumors. healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including A Study of NM-3 Administered Orally in Patients with Advanced Solid Tumors.. A Study of NM-3 Administered Orally in Patients with Advanced Solid Tumors. Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Study of NM-3 Administered Orally in Patients with Advanced Solid Tumors. clinical trial. Test subjects typically receive the most effective healthcare possible for their A Study of NM-3 Administered Orally in Patients with Advanced Solid Tumors. condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study of NM-3 Administered Orally in Patients with Advanced Solid Tumors.  A Study of NM-3 Administered Orally in Patients with Advanced Solid Tumors.
A Study of NM-3 Administered Orally in Patients with Advanced Solid Tumors.
For Condition: Neoplasms
Status: Recruiting
Sponsor(s): ILEX Products ,
Synopsis: A study for patients who have failed standard therapy. If there is no dose limiting toxicities the patients will receive further cycles of therapy if there is no evidence of disease progression.
Details: This is a non-randomized, open-label, Phase I study. A modified Fibonacci dose escalation will be used to determine the MTD for subsequent Phase II trials. Study duration is expected to be 12 to 18 months. Patients with a histological or cytological diagnosis of a solid tumor who have failed standard therapy or for whom no standard therapy exists are enrolled. If there is no dose limiting toxicities and if patients meet the inclusion criteria and have none of the exclusion criteria of the protocol, they will receive further cycles of therapy if there is no evidence of disease progression.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: Patients must: - be at least 18 years of age. - have an advanced solid tumor that has failed standard therapy or for which no standard therapy exists. - have a histological or cytological diagnosis of a malignant solid tumor. - have measurable or non-measurable disease as defined in the protocol. - have completed any chemotherapy, radiotherapy, or major surgery at least 4 weeks prior to study entry (6 weeks for nitrosoureas or mitomycin C) and recovered from the toxic effects of any prior surgery. - have a Karnofsky performance status index greater than or equal to 80. - have adequate organ and immune system function as indicated by specific laboratory values, obtained less than or equal to 7-days prior to treatment with NM-3. - have a negative serum pregnancy test within 7 days of study enrollment (females of child bearing potential). - men and women with reproductive potential must use an effective contraceptive method while enrolled in this study and for 3 months after the patient has completed study. - be able to swallow. - have signed, written informed consent. - an estimated life expectancy of at least 12 weeks. Exclusion Criteria: Patients who meet any of the following criteria will be excluded from study admission: - Known sensitivity to study drug or its analogs. - Treatment with any investigational therapy within the preceding 4 weeks. - Hematological malignancies including leukemia, lymphoma, or multiple myeloma. - Active and uncontrolled infection. - Psychiatric disorders, alcohol or chemical abuse that would interfere with consent or follow-up. - Uncontrolled congestive heart failure or angina. - Pregnancy or lactation. - Any other severe concurrent disease, which as judged by the investigator, would make the patient inappropriate for entry into this study. - Active gastrointestinal bleeding or ulceration, unhealed wounds or active thrombosis. - On anticoagulant therapy or taking aspirin, nonsteroidal anti-inflammatory drugs, unfractionated heparin, low molecular weight heparin, danaproid, thrombolytic agents, anti-platelet antibodies, glycoprotein IIb, IIIa antagonists, H2 blockers, or proton pump inhibitors. - Brain or leptomeningeal metastases. - Known HIV positive status or who have an AIDS-related illness. - History of gastrointestinal bleeding from varices, arteriovenous malformations, Osler Weber Rendu syndrome, polyps, prior surgery, or gastric ulcerations. Patients who had bleeding not associated with a coagulopathy after surgery or gastric ulceration and who have no further bleeding or recurrence of their ulcers for more than one year are eligible for this study. - Patients with a total accumulated doxorubicin or equivalent dose over 450 mg/m2. - Patients with more than 1 risk factor, where a risk factor is defined as any one of the following (1-7): 1. prior anthracyclines larger than 300 mg/m2 doxorubicin equivalent. 2. mediastinum/left breast irradiation. 3. history of arterial hypertension (systolic blood pressure greater than 140 or diastolic blood pressure greater than 90, or receiving anti-hypertensive treatment). 4. obesity (body mass index). 5. diabetes mellitus (fasting plasma glucose level greater than 126 mg/dL American Diabetes Association guidelines). 6. smoking (any smoking in the month prior to study entry). 7. hypercholesterolemia (greater than 240 mg/dL).
Total Enrollment: 32
Location and Contact Information:
Additional Information:
Study ID Numbers: NM-103;
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00046696
Other Neoplasms Studies:
1. Phase 1 Study OF CDC-501 in Patients with Solid Tumors
2. A Safety and Effectiveness Study of Aroplatin in Patients with Advanced Solid Malignancies
3. Phase I Study of Noni in Cancer Patients
4. A Trial to Evaluate Epothilone D in Patients with Advanced Solid Tumors
5. Studies of the Immune Response in Normal Subjects and Patients with Disorders of the Immune System
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A Study of NM-3 Administered Orally in Patients with Advanced Solid Tumors.
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