Overview

SU5416 in Treating Patients With Advanced Solid Tumors

Status:
Completed
Trial end date:
2005-11-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Semaxinib
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

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

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