Non Hodgkin Lymphoma Clinical Trial
CT-322 in Treating Patients With Advanced Solid Tumors and Non-Hodgkin’s Lymphoma
Summary
RATIONALE: CT-322 may stop the growth of solid tumors or non-Hodgkin's lymphoma by stopping blood flow to the cancer.
PURPOSE: This phase I trial is studying the side effects of CT-322 in treating patients with advanced solid tumors or non-Hodgkin's lymphoma.
Eligibility Criteria
DISEASE CHARACTERISTICS
Histologically proven advanced solid malignancy or NHL for which no standard therapy exists or for which standard therapy had failed
No known brain or leptomeningeal disease
No prior bone marrow transplant or stem cell rescue
No histologically confirmed squamous non-small cell lung cancer (NSCLC) with central chest tumor(s) still in place
PATIENT CHARACTERISTICS
Age:
* 18 and over
Performance status:
* ECOG performance status ≤ 2
Life expectancy:
* > 3 months
Hematopoietic:
ANC ≥ 1500/mL
Platelets ≥ 100,000/mL
Hemoglobin ≥ 9.0 g/dL; and not requiring transfusion > 1 unit/month
Hepatic:
AST and ALT ≤ 2.5 x ULN; if liver function abnormalities are due to the underlying malignancy, then AST and ALT may be ≤ 5 x the ULN
Bilirubin ≤ 1.5 x ULN
aPTT and PT < 1.5 x ULN
Renal:
Creatinine ≤ 1.5 x ULN; patients with serum creatinine > 1 x ULN must also have creatinine clearance (based on a 24-hour urine collection) ≤ 60 mL/min
No proteinuria > 1+ on dipstick analysis; in the case of > 1+ dipstick proteinuria, a 24-hour urine collection for protein must be < 500 mg/24 hours
Urinary protein/creatinine ratio < 1
No glomerulonephritis
Cardiovascular:
No coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, unstable angina, symptomatic congestive heart failure, severe uncontrolled hypertension, hemorrhagic or thrombotic stroke or any other CNS bleeding within the preceding 12 months
LVEF normal by echocardiogram or MUGA within the past 12 months if there was prior exposure to anthracyclines or radiotherapy encompassing the heart
Immunologic:
* Not known to have human immunodeficiency virus (HIV), active hepatitis virus C (HVC), or active hepatitis virus B (HVB)
Other:
Negative pregnancy test within 7 days prior to enrollment
Not pregnant or breast feeding
Fertile patients must agree to use effective contraception or commit to abstinence during the study period, or be surgically sterile
No serious nonhealing wound, ulcer, or bone fracture
Have the ability to understand and sign an informed consent document
Be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
PRIOR CONCURRENT THERAPY:
Biologic therapy:
See Disease Characteristics
At least 4 weeks since prior biological or immunotherapy and recovered
Chemotherapy:
See Disease Characteristics
At least 4 weeks since prior chemotherapy and recovered
At least 6 weeks for mitomycin C and nitrosoureas prior to study entry and recovered
Radiotherapy:
* At least 4 weeks since prior radiotherapy to a visceral organ and recovered
Surgery:
At least 4 weeks since prior major or laparoscopic surgery and recovered
At least 1 week since prior minor surgery
Other:
No other concurrent anticancer therapy
Not concurrently enrolled in another therapeutic clinical trial involving ongoing therapy
No concurrent full dose, therapeutic anti-coagulation with warfarin or related oral anti-coagulants or unfractionated or low molecular weight heparins; low dose warfarin for catheter prophylaxis or acetylsalicylic acid ≤ 325 mg/day is acceptable
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There are 3 Locations for this study
Indianapolis Indiana, 46202, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78245, United States
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