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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

Thank you

Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of CT-322

Outcome Time Frame:

Throughout the study

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

CT-322.001

NCT ID:

NCT00374179

Start Date:

August 2006

Completion Date:

February 2009

Related Keywords:

  • Cancer
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Institute for Drug DevelopmentSan Antonio, Texas  78245-3217
South Texas Accelerated Research TherapeuticsSan Antonio, Texas  78229