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

Pancreatic Cancer Clinical Trial

Official title:

An Open-Label, Phase I, Repeat Dose-Escalation Study of ABR-217620 in Patients With Advanced Non-Small Cell Lung Cancer, Renal Clear Cell Carcinoma or Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00056537
• Other study ID #: 01762001
• Status: Completed
• Phase: Phase 1
• First received: March 16, 2003
• Last updated: August 26, 2014
• Start date: April 2003
• Est. completion date: December 2006

Study information

• Verified date: August 2014
• Source: Active Biotech AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationNorway: Norwegian Medicines AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Renal Cell
• Lung Neoplasms
• Non-Small-Cell Lung Carcinoma
• Pancreatic Cancer
• Pancreatic Neoplasms
• Renal Cell Carcinoma

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Norway	Det Norske Radiumhospitalet	Oslo
United Kingdom	Paterson Institute for Cancer Research, Christie Hospital NHS Trust and Research Institute	Manchester
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Active Biotech AB

Countries where clinical trial is conducted

United States,  Norway,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD) as a function of pre-treatment anti-SEA/E-120 levels		56 days after start of first treatment cycle	Yes
Secondary	Safety profile		During or after first treatment cycle, second treatment cycle, later cycles if available	Yes
Secondary	Pharmacokinetic parameters		Days 1 and 5 of each cycle	No
Secondary	Immunological response		Days 28 and 56 of first and second treatment cycles, later cycles if available	Yes
Secondary	Objective response rate		Days 28 and 56 of first and second treatment cycles, later cycles if available	No
Secondary	Time to progression and Survival		Followed for up to 2 years	No