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Home > "S" Clinical Trials Conditions > SU5416 in Treating Patients With Advanced Solid Tumors  SU5416 in Treating Patients With Advanced Solid Tumors
SU5416 in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Ireland Cancer Center
Synopsis: RATIONALE: SU5416 may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of SU5416 in treating patients who have advanced solid tumors.
Details: OBJECTIVES: I. Determine the maximum target-inhibiting dose of SU5416 in patients with advanced solid tumors. II. Determine the relationship between dose or plasma levels and the clinical safety profile and antitumor effects of this treatment regimen in terms of objective response, stabilization of disease, or progression-free survival in this patient population. III. Evaluate the relationship between dose or plasma levels of SU5416 concentrations and the ability of this treatment regimen to reduce microvessel density and induce apoptosis of endothelial and tumor cells in this patient population. IV. Determine prognostic and surrogate serologic markers in these patients treated with this regimen. V. Determine if pre and posttreatment plasma and serum levels of angiogenic growth factors, basic fibroblast growth factor, and vascular endothelial cell growth factor are prognostic in predicting patient response to this regimen. VI. Determine if elevated plasma levels of endothelial cell specific proteins reflective of SU5416-induced endothelial damage and/or apoptosis are useful surrogate markers in assessing response to this treatment regimen in these patients. PROTOCOL OUTLINE: This is a dose-deescalation study. Patients receive SU5416 IV over 1 hour twice weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 6-12 patients receive deescalating doses of SU5416 until the maximum target-inhibiting dose (MTID) is determined. The MTID is defined as the dose at which patients experience no greater than grade 1 toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: Approximately 20-30 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 confirmed solid tumors not amenable to conventional therapy - At least 2 distinct lesions of metastatic or primary tumor of at least 1-2 cm OR Single lesion if large enough for both biopsy and MRI flow studies - No brain metastases or primary brain tumors --Prior/Concurrent Therapy-- - Biologic therapy: At least 3 weeks since prior biologic therapy and recovered - Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered - Endocrine therapy: At least 3 weeks since prior hormonal therapy and recovered - Radiotherapy: At least 4 weeks since prior large field radiotherapy and recovered - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: At least 12 weeks - Hematopoietic: WBC at least 3,500/mm3; Granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin greater than 9.0 g/dL - Hepatic: Bilirubin normal; PT normal OR INR less than 1.1 PTT normal - Renal: Creatinine less than 1.5 mg/dL AND/OR Creatinine clearance greater than 60 mL/min - Cardiovascular: No New York Heart Association class III or IV heart disease; No uncompensated coronary artery disease on electrocardiogram or physical exam; No myocardial infarction or severe or unstable angina within the past 6 months; No severe peripheral vascular disease associated with diabetes mellitus; No deep vein thrombosis or arterial thrombosis within the past 3 months - Pulmonary: No pulmonary embolism within the past 3 months - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AfshinDowlati, Study Chair, Ireland Cancer Center
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Additional Information:
Study ID Numbers: CDR0000067805; NCI-T99-0095,CWRU-2Y99
Study Start Date: May 2000
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005642
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors
2. BMS-214662 Plus Trastuzumab in Treating Patients With Advanced Solid Tumors
3. R115777 in Treating Patients With Advanced Solid Tumors
4. Docetaxel and GEM 231 in Treating Patients with Recurrent or Refractory Solid Tumors
5. Combination Chemotherapy Plus Oblimersen in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Ohio Clinical Trials
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SU5416 in Treating Patients With Advanced Solid Tumors
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