CT-322 in Treating Patients With Advanced Solid Tumors and Non-Hodgkin's Lymphoma

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Escalating Dose Study of CT-322, a VEGFR-2 Antagonist, as Monotherapy in Patients With Advanced Solid Tumors and Non-Hodgkin's Lymphoma

Conditions
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Cancer

Intervention / Treatment
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* Drug: CT-322


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CT-322|IV solution, weekly or bi-weekly|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of CT-322 |  | Throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pharmacokinetics of CT-322 in these patients; |  | Throughout the study | 
| to assess whether antibodies to this drug develop in these patients; and |  | Throughout the study | 
| to make a preliminary assessment of the biological activity of CT-322 to alter tumor growth. |  | Throughout the study |