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Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors Clinical research trials and Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors. Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors clinical trial. Human subjects often receive the most effective healthcare possible for their Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors  Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors
Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors
For Condition: childhood brain tumor,Neuroblastoma,Gastrointestinal Cancer,Ewing's family of tumors,adult solid tumor,childhood solid tumor
Status: Recruiting
Sponsor(s): Holden Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Radiolabeledoctreotide can locate tumor cells and deliver radioactive tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of radiolabeled octreotide in treating children who have advanced or refractorysolid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose of yttrium Y 90-DOTA-tyr3-octreotide in children with advanced or refractory somatostatin receptor-positive tumors. - Determine the short-term and long-term safety and the serious adverse-event profiles of this drug in these patients. - Determine any potential antitumor effect of this drug in these patients. - Correlate level of somatostatin receptor type 2 expression with response in patients treated with this drug. OUTLINE: This is a dose-escalation study. Patients receive yttrium Y 90-DOTA-tyr3-octreotide IV over 5-10 minutes on day 1. Treatment repeats every 6 weeks for up to 3 courses in the absence of unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of yttrium Y 90-DOTA-tyr3-octreotide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 3, 6, 12, and 18 months and then every 6 months thereafter. PROJECTED ACCRUAL: Approximately 28-39 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 2 Years/21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed malignant neoplasm - Not amenable to standard therapy or has failed existing first- and second-line therapies - Tumor positive for somatostatin receptors by OctreoScan within the past 4 weeks - At least 1 measurable lesion - Lesions that have been previously irradiated must demonstrate progression since radiation - At least 1 measurable somatostatin receptor-positive lesion that has not been irradiated within the past 4 weeks AND has not had full craniospinal radiation within the past 3 months - Bone marrow with at least 40% cellularity OR at least 20% cellularity with one million CD34+ stem cells/kg stored - No diffuse bone marrow involvement by OctreoScan scintigraphy PATIENT CHARACTERISTICS: Age - 2 to 21 Performance status - COG 0-2 OR - Karnofsky 60-100% OR - Lansky 60-100% Life expectancy - 2-12 months Hematopoietic - See Disease Characteristics - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin less than 1.5 times normal - AST and ALT less than 2.5 times upper limit of normal Renal - Creatinine no greater than 1 mg/dL (children less than 5 years of age) - Creatinine less than 1.2 mg/dL (children 5 to 10 years of age) - Creatinine less than 1.7 mg/dL (children over 10 years of age) AND - Glomerular filtration rate at least 80 mL/min Cardiovascular - Shortening fraction at least 24% by echocardiogram - Ejection fraction at least 50% by bi-plane method of echocardiogram - No prior congestive heart failure unless ejection fraction at least 40% - No unstable angina pectoris - No cardiac arrhythmia - No symptomatic congestive heart failure Other - No other concurrent malignancy - No other significant uncontrolled medical, psychiatric, or surgical condition that would preclude study compliance - No antibodies to yttrium Y 90-DOTA-tyr3-octreotide or octreotide - No prior allergic reactions to compounds of similar chemical or biologic composition to yttrium Y 90-DOTA-tyr3-octreotide - No ongoing or active infection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy - More than 120 days since prior long-acting somatostatin analogues - No concurrent somatostatin analogues 12 hours before or 12 hours after study drug administration - Concurrent hormonal therapy (other than somatostatin analogue) allowed provided patient received hormonal therapy for at least 2 months and has stable disease or progressive disease Radiotherapy - See Disease Characteristics - At least 4 weeks since prior radiotherapy - No prior radiotherapy to 25% or more of bone marrow - No prior external beam radiotherapy to both kidneys (scatter doses of less than 500 cGy to a single kidney or radiation to less than 50% of a single kidney is allowed) Surgery - At least 4 weeks since prior surgery Other - Recovered from prior therapy - At least 4 weeks since prior investigational drugs - No other concurrent approved or investigational anti-neoplastic therapies except for bisphosphonates - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
M.O'Dorisio, Study Chair, Holden Comprehensive Cancer Center
Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City, Iowa, 52242-1009
United States
Recruiting M. O'Dorisio 319-356-7873
Additional Information:
Study ID Numbers: CDR0000257582; NCI-V02-1710,UIHC-200008086
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049023
Other Adult Solid Tumor Studies:
1. Study of the Emotional Needs of Caregivers of Stem Cell Transplantation Patients
2. CHP677: I-Metaiodobenzylguanidine (I-MIBG) therapy for refractory neuroblastoma: a Phase II study
3. Pentostatin in Treating Patients With Refractory Chronic Graft-Versus-Host Disease
4. Monoclonal Antibody A1G4 Plus BCG in Treating Patients With Cancer
5. Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Brain Tumor
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Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors
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