ABR-217620 in Patients With Advanced Non-Small Cell Lung Cancer, Renal Clear Cell Carcinoma or Pancreatic Cancer

NCT ID: NCT00056537

Last Updated: 2014-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2006-12-31

Brief Summary

The drug ABR-217620 is a combination of two proteins, one that recognizes tumor cells and one that triggers an attack on the tumor cells by activating some white blood cells belonging to the body's normal immune system. In animals, this results in an accumulation of white blood cells in the cancer that can fight the cancer. This study will test how much of the drug can be given to patients with non-small cell lung cancer, renal clear cell carcinoma, or pancreatic cancer without causing unacceptable side effects.

Conditions

Non-Small-Cell Lung Carcinoma; Renal Cell Carcinoma; Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

ABR-217620

Intervention Type: DRUG

Starting dose: 0.5 mcg/kg; subsequent doses: individual, based on pre-treatment level of anti-SEA/E-120, body weight, and toxicities observed in prior patients on study; IV; one bolus injection each day for 5 consecutive days; up to 3 cycles

Interventions

ABR-217620

Starting dose: 0.5 mcg/kg; subsequent doses: individual, based on pre-treatment level of anti-SEA/E-120, body weight, and toxicities observed in prior patients on study; IV; one bolus injection each day for 5 consecutive days; up to 3 cycles

Intervention Type: DRUG

Other Intervention Names

CD3; 5T4FabV18-SEA/E-120; naptumomab estafenatox; Anyara

Eligibility Criteria

Inclusion Criteria

• Patients with histologically or cytologically confirmed non-small cell lung cancer, which is refractory to (progressed on or following) currently available standard therapies. Patients must have received (or declined) at least one standard regimen for advanced/metastatic disease.
• ECOG performance status of 0 or 1.
• Adequate bone marrow function as defined by absolute neutrophil count greater than or equal to 1500/mm3, and platelets greater than or equal to 100,000/mm3, and hemoglobin greater than or equal to 10 g/dL.
• Adequate renal function: creatinine less than or equal to 1.5 x upper limit of normal.
• Adequate hepatic function: bilirubin less than or equal to 2 x upper limit of normal, and SGOT (S-ASAT) and SGPT (S-ALAT) less than or equal to 2.5 x upper limit of normal.
• Life expectancy greater than 3 months.

Exclusion Criteria

• Pregnant or breast-feeding women, or women of childbearing potential unless effective methods of contraception are used.
• A serious uncontrolled medical disorder or active infection that would impair the patient's ability to receive study treatment.
• History of or any concurrent malignancy, with the exception of the following malignancies, which may still be included: non-melanoma skin cancer, cervical cancer in situ, DCIS or LCIS of breast, past history of resected melanoma without clinical evidence of recurrent melanoma, past history of prostate cancer without clinical evidence of disease (includes patients receiving hormonal therapy).
• History of brain metastases, unless stable for more than 4 weeks, and not requiring steroid therapy and without clinical symptoms of brain metastases.
• Acute illness or evidence of infection, including unexplained fever (temperature greater than 100.5 degrees Fahrenheit or 38.1 degrees Celsius).
• Significant symptomatic cardiac disease including: history (within the past 6 months) or current unstable angina, congestive heart failure, or myocardial infarction; or patients with uncontrolled hypertension, or hypertension that is controlled only with multiply drugs (control by monotherapy is permitted).
• History of or current arrhythmias requiring treatment, with the exception of non-specific, asymptomatic ST-T wave changes or extrasystoles.
• History of cerebrovascular accident within the past 5 years.
• Seizure disorder requiring therapy.
• Treatment with beta-blockers, including topical therapy for glaucoma, during the 6-day treatment period (5 days' treatment + 1 day in patient follow-up), and within five days prior to start of treatment.
• Simultaneous participation in any other study involving investigational drugs or having participated in a study less than 4 weeks prior to start of study treatment.
• Treatment with systemic or inhaled corticosteroids within 2 weeks prior to the start of treatment.
• Treatment with anticoagulants, except when used to maintain the patency of a central venous line.
• Active autoimmune disease requiring therapy or any history of systemic lupus erythematosus or rheumatoid arthritis.
• Chemo/radio/immunotherapy less than 4 weeks (6 weeks for mitomycin C and nitrosoureas) before start of treatment.
• Major surgery less than 3 weeks.
• Known positive serology for HIV (patients with a known history of HIV will be excluded because of potential for unforeseen toxicity and morbidity in the immunocompromised host).
• Known chronic Hepatitis B or C.
• Previous exposure to murine monoclonal antibody (with HAMA titer above detection limit at baseline) or known hypersensitivity to murine proteins.
• Patients currently on renal dialysis treatment.
• Known allergy or hypersensitivity to aminoglycosides e.g. kanamycin.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Active Biotech AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suzanne Kilany

Role: STUDY_DIRECTOR

Active Biotech AB

Locations

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Det Norske Radiumhospitalet

Oslo, , Norway

Paterson Institute for Cancer Research, Christie Hospital NHS Trust and Research Institute

Manchester, , United Kingdom

Countries

United States; Norway; United Kingdom

Other Identifiers

01762001

Identifier Type: -

Identifier Source: org_study_id