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EMD 121974 in Treating Patients With Advanced Solid Tumors Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about EMD 121974 in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. EMD 121974 in Treating Patients With Advanced Solid Tumors Clinical research trials and EMD 121974 in Treating Patients With Advanced Solid Tumors health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including EMD 121974 in Treating Patients With Advanced Solid Tumors. EMD 121974 in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a EMD 121974 in Treating Patients With Advanced Solid Tumors clinical trial. Human subjects often get the best healthcare possible for their EMD 121974 in Treating Patients With Advanced Solid Tumors condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > EMD 121974 in Treating Patients With Advanced Solid Tumors  EMD 121974 in Treating Patients With Advanced Solid Tumors
EMD 121974 in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): University of Colorado Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: EMD 121974 may slow the growth of solid tumors by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of EMD 121974 in treating patients who have advanced solid tumors.
Details: OBJECTIVES: - Determine the toxic effects and maximum tolerated dose of EMD 121974 in patients with advanced solid tumors. - Determine the biologic activity of this drug in these patients. - Determine the pharmacokinetic profile and plasma biological effects of this drug and identify any relationship with its biologic activity or observed toxicity in these patients. - Determine, preliminarily, the antitumor efficacy of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients receive EMD 121974 IV over 1 hour twice weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-10 patients receive escalating doses of EMD 121974 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 10-35 patients will be accrued for this study within 12-18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy exists - Tumors must be amenable to minimally-invasive biopsy (i.e., tumors must be superficial enough to be sampled by punch biopsy or core biopsy procedure without radiologic guidance)* NOTE: *For at least 6 patients per cohort - No uncontrolled brain metastases, including symptomatic lesions or lesions requiring glucocorticoids and/or anticonvulsants to suppress symptoms - Negative brain scan required if there are signs and symptoms suggestive of brain metastasis PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy: - At least 12 weeks Hematopoietic: - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic: - Bilirubin normal - AST and ALT no greater than 2.5 times upper limit of normal Renal: - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris Other: - No ongoing or active infection - No other concurrent serious systemic disorders (e.g., significant CNS illness) that would preclude study - No concurrent psychiatric illness or social situations that would preclude study - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No other concurrent anticancer immunotherapy - Concurrent hematologic growth factors for cytopenias allowed Chemotherapy: - At least 4 weeks since prior anticancer chemotherapy (6 weeks for nitrosoureas, carmustine, or mitomycin) and recovered Endocrine therapy: - See Disease Characteristics - No concurrent anticancer hormonal therapy - Concurrent oral contraceptives or postmenopausal hormone replacement allowed Radiotherapy: - Recovered from prior radiotherapy - At least 2 weeks since prior palliative radiotherapy to bone or brain metastases - At least 4 weeks since prior anticancer radiotherapy - No concurrent anticancer radiotherapy Surgery: - Not specified Other: - At least 4 weeks since prior anticancer therapy and recovered - At least 4 weeks since prior investigational agents - Any number of prior therapies allowed - No other concurrent anticancer investigational or commercial agents - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ScottHolden, Study Chair, University of Colorado Cancer Center
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Aurora, Colorado, 80010
United States
Recruiting Scott Holden 720-848-0363
Additional Information:
Study ID Numbers: CDR0000068786; UCHSC-001096,NCI-3358
Study Start Date:
Record last reviewed: November 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022113
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Combination Chemotherapy in Treating Patients With Solid Tumors
2. Improving Pain Management in Patients With Nonhematologic Cancer
3. Inhaled Morphine Compared With Morphine By Mouth in Treating Cancer Patients With Breakthrough Pain
4. 3-AP and Doxorubicin In Treating Patients With Metastatic or Refractory Solid Tumors
5. Cisplatin Plus Bryostatin 1 in Treating Patients With Advanced Cancer
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Colorado Clinical Trials
Other Aurora Clinical Trials
EMD 121974 in Treating Patients With Advanced Solid Tumors
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