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Yttrium Y 90 SMT 487 in Treating Patients With Refractory or Recurrent Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Yttrium Y 90 SMT 487 in Treating Patients With Refractory or Recurrent Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Yttrium Y 90 SMT 487 in Treating Patients With Refractory or Recurrent Cancer Clinical research trials and Yttrium Y 90 SMT 487 in Treating Patients With Refractory or Recurrent Cancer health trials occur in many 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 effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Yttrium Y 90 SMT 487 in Treating Patients With Refractory or Recurrent Cancer. Yttrium Y 90 SMT 487 in Treating Patients With Refractory or Recurrent Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Yttrium Y 90 SMT 487 in Treating Patients With Refractory or Recurrent Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Yttrium Y 90 SMT 487 in Treating Patients With Refractory or Recurrent Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "Y" Clinical Trials Conditions > Yttrium Y 90 SMT 487 in Treating Patients With Refractory or Recurrent Cancer  Yttrium Y 90 SMT 487 in Treating Patients With Refractory or Recurrent Cancer
Yttrium Y 90 SMT 487 in Treating Patients With Refractory or Recurrent Cancer
For Condition: Brain Tumor,Breast Cancer,Lung Cancer,Lymphoma,Melanoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , H. Lee Moffitt Cancer Center and Research Institute
Synopsis: RATIONALE: Radiolabeled drugs such as yttrium Y 90 SMT 487 can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of yttrium Y 90 SMT 487 in treating patients who have refractory or recurrent cancer.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of yttrium Y 90-SMT 487 in patients with recurrent malignant neoplasms that prove positive for somatostatin receptors. II. Determine the safety and lifetime serious adverse event profile of this regimen in these patients. II. Determine the antitumor effect and the effect of repeated administrations on the renal excretion pharmacokinetics of this regimen in these patients. PROTOCOL OUTLINE: This is a dose escalation, multicenter study. Patients undergo octreotide scintigraphy to determine the location of somatostatin receptors. Patients then receive yttrium Y 90-SMT 487 IV over 15 minutes on day 1. Treatment continues every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients each are entered on course I (vertical dose escalation) and courses II, III, and IV (horizontal dose escalation). Cohorts receive escalating doses of yttrium Y 90-SMT 487 until the maximum tolerated dose (MTD) is determined. MTDs are determined for a single course and for 4 courses. The MTD is defined as the dose preceding that at which no more than 2 of 6 patients experience dose limiting toxicities. Results of course I determine the dosage of subsequent courses. Patients are evaluated on days 2 and 7, and at weeks 4 and 6, following each injection of yttrium Y 90-SMT 487. Patients are followed at 12 and 18 months and then annually thereafter. PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed, progressive malignant neoplasm; Clinical diagnosis of multiple endocrine neoplasia (MEN) types I and II allowed; Tumors positive for somatostatin receptors by octreotide scintigraphy, such as: Brain; Endocrine; Pancreatic; Lymphoma; Melanoma; Small cell; Lung; Breast; Disease not amenable to standard treatment OR Failed existing first and second line therapies (failed at least 1 regimen in the case of small cell lung cancer) - Bone disease (no diffuse bone marrow involvement), pleural effusions, and ascites allowed --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy Greater than 4 weeks since prior chemotherapy - Endocrine therapy: At least 4 months since prior long acting somatostatin analogue; Concurrent hormonal therapy (except somatostatin analogues) allowed if started at least 2 months previously - Radiotherapy: Greater than 4 weeks since prior radiotherapy; No prior radiotherapy to at least 25% of bone marrow - Surgery: Greater than 4 weeks since prior surgery - Other: Greater than 4 weeks since prior investigational drugs; No other concurrent investigational drug therapy; No other concurrent antineoplastic therapy; Concurrent bisphosphonates allowed --Patient Characteristics-- - Age: 18 and over - Performance status: Course I: Karnofsky 50-100%; Courses II-IV: Karnofsky 30-100% - Life expectancy: At least 6 months and no greater than 2.5 years (for course I only) - Hematopoietic: Course I: Hemoglobin at least 8 g/dL; WBC at least 3,500/mm3; Platelet count at least 100,000/mm3; Courses II-IV: WBC at least 3,000/mm3; Platelet count at least 75,000/mm3 - Hepatic: Not specified - Renal: Creatinine no greater than 1.7 mg/dL OR Creatinine clearance at least 40 mL/min - Cardiovascular: No history of congestive heart failure unless ejection fraction at least 40% - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 6 months after study; No other concurrent malignancy except MEN I or II or squamous cell skin cancer; No concurrent significant, uncontrolled, medical, psychiatric, or surgical condition that would preclude study (course 1)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LarryKvols, Study Chair, H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Additional Information:
Study ID Numbers: CDR0000068241; MCC-IRB-5473,NCI-G00-1857,NOVARTIS-SMT-B151,MCC-12275
Study Start Date: November 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006368
Other Brain Tumor Studies:
1. Phase I Trial in Patients with Metastatic Melanoma of Immunization with a Recombinant Fowlpox Virus Encoding the gp100 Melanoma Antigen
2. Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects with Metastatic Malignant Melanoma
3. ADI-PEG in Patients With Metastatic Melanoma
4. Study of Talabostat in Advanced Melanoma
5. Immunotherapy After Surgery in Treating Patients With Breast Cancer, Colon Cancer, or Melanoma
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Yttrium Y 90 SMT 487 in Treating Patients With Refractory or Recurrent Cancer
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