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

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ABR-217620
Sponsored by
Active Biotech AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small-Cell Lung Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fox Chase Cancer Center
  • Det Norske Radiumhospitalet
  • Paterson Institute for Cancer Research, Christie Hospital NHS Trust and Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose (MTD) as a function of pre-treatment anti-SEA/E-120 levels

Secondary Outcome Measures

Safety profile
Pharmacokinetic parameters
Immunological response
Objective response rate
Time to progression and Survival

Full Information

First Posted
March 16, 2003
Last Updated
August 26, 2014
Sponsor
Active Biotech AB
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1. Study Identification

Unique Protocol Identification Number
NCT00056537
Brief Title
ABR-217620 in Patients With Advanced Non-Small Cell Lung Cancer, Renal Clear Cell Carcinoma or Pancreatic Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Active Biotech AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ABR-217620
Other Intervention Name(s)
CD3; 5T4FabV18-SEA/E-120; naptumomab estafenatox; Anyara
Intervention Description
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
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD) as a function of pre-treatment anti-SEA/E-120 levels
Time Frame
56 days after start of first treatment cycle
Secondary Outcome Measure Information:
Title
Safety profile
Time Frame
During or after first treatment cycle, second treatment cycle, later cycles if available
Title
Pharmacokinetic parameters
Time Frame
Days 1 and 5 of each cycle
Title
Immunological response
Time Frame
Days 28 and 56 of first and second treatment cycles, later cycles if available
Title
Objective response rate
Time Frame
Days 28 and 56 of first and second treatment cycles, later cycles if available
Title
Time to progression and Survival
Time Frame
Followed for up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Kilany
Organizational Affiliation
Active Biotech AB
Official's Role
Study Director
Facility Information:
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Det Norske Radiumhospitalet
City
Oslo
Country
Norway
Facility Name
Paterson Institute for Cancer Research, Christie Hospital NHS Trust and Research Institute
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

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

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