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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00374179
Enrollment
40
Registered
2006-09-11
Start date
2006-08-31
Completion date
2009-02-28
Last updated
2009-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Brief 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.

Interventions

DRUGCT-322

IV solution, weekly or bi-weekly

Sponsors

Adnexus, A Bristol-Myers Squibb R&D Company
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Safety and tolerability of CT-322Throughout the study

Secondary

MeasureTime 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; andThroughout the study
to make a preliminary assessment of the biological activity of CT-322 to alter tumor growth.Throughout the study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026