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ABR-217620 in Combination With Docetaxel in Patients With Advanced Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00132379
Recruitment Status : Completed
First Posted : August 22, 2005
Last Update Posted : August 27, 2014
Sponsor:
Information provided by (Responsible Party):

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, in combination with docetaxel (an approved drug for treating non-small cell lung cancer [NSCLC]), can be given to patients with NSCLC without causing unacceptable side effects.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: ABR-217620 Drug: docetaxel Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Phase I, Dose-escalation Study of ABR-217620 in Combination With Docetaxel in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Study Start Date : November 2005
Primary Completion Date : December 2006
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: ABR-217620
10.3, 16.5 or 22 mcg/kg, IV, daily 5 minute bolus injection for 4 consecutive day per cycle; up to 6 cycles
Other Name: CD3; 5T4FabV18-SEA/E-120; naptumomab estafenatox; Anyara
Drug: docetaxel
75mg/m^2, IV, single 60 minute infusion, beginning on Day 5 then every third week
Other Name: Taxotere


Outcome Measures

Primary Outcome Measures :
  1. Side effect profile (based on blood pressure, body temperature, and laboratory tests) [ Time Frame: Day 56 (Day 115 if undergo cycles 3/4) ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameters [ Time Frame: Days 1 and 4 of cycles 1 and 2 ]
  2. Immunological response [ Time Frame: Day 56 (Day 115 if undergo cycles 3/4) ]
  3. Changes in anti-SEA/E-120 levels [ Time Frame: Day 56 (Day 115 if undergo cycles 3/4) ]
  4. Objective response rate [ Time Frame: Day 56 (Day 115 if undergo cycles 3/4) ]
  5. Time to progression and Survival [ Time Frame: Followed for up to 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histologically or cytologically confirmed advanced NSCLC who have progressed on first line platin-based therapy or have failed on other treatment regimens or declined standard regimen.
  • ECOG performance status 0 or 1.
  • Adequate bone marrow function: absolute neutrophil count greater than or equal to 1500/mm3; WBC greater than or equal to 3000/mm3; 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 (ULN).
  • Adequate hepatic function: bilirubin less than ULN; and SGOT (AST) and SGPT (ALT) to less than 1.5 x ULN concomitant with alkaline phosphatase (ALP) less than 2.5 ULN.

Exclusion Criteria:

  • Female patients who are pregnant or nursing or planning to become pregnant during the study. Fertile, sexually active women not willing to practice reliable contraception. Male patients with partners of childbearing potential not using acceptable contraceptive method.
  • A serious uncontrolled medical disorder or active infection including unexplained fever (temperature greater than 100.5 degrees Fahrenheit or 38.1 degrees Celsius) that would impair the patient's ability to receive study treatment.
  • Any concurrent malignancy, except for the following malignancies that may be included: non-melanoma skin cancer; cervical cancer in situ; ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) of breast; or 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.
  • Significant symptomatic cardiac disease including history (within past 6 months) or current unstable angina, congestive heart failure, or myocardial infarction; or patients with uncontrolled hypertension, or hypertension requiring treatment with more than 2 drugs.
  • History of or current arrhythmias requiring treatment, except for non-specific, asymptomatic ST-T wave changes or extrasystoles.
  • Seizure disorder requiring therapy.
  • Treatment with beta-blockers, including topical therapy for glaucoma, during the 6-day treatment period (5-day treatment + 1 day in-patient follow-up), and within 5 days before start of ABR-217620 treatment.
  • Simultaneous participation in any other investigational drug study or participation in a study less than 4 weeks before start of study treatment.
  • Treatment with systemic or inhaled corticosteroids within 2 weeks before 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.
  • Concurrent biological response modifiers (within 3 weeks of study entry) except for any type of erythropoetin.
  • Chemo/radio/immunotherapy less than 4 weeks (6 weeks for mitomycin C and nitrosoureas) before start of treatment.
  • Known allergy or hypersensitivity reactions to aminoglycosides (e.g., kanamycin).
  • Known allergy or hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80.
  • Previous exposure to murine monoclonal antibody (with human anti-mouse antibody [HAMA] titer above detection limit at baseline) or known hypersensitivity to murine proteins.
  • Major surgery within 3 weeks.
  • Known history of HIV infection.
  • Known chronic hepatitis B or C.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132379


Locations
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Denmark
Onkologisk Klinik, Rigshospitalet
Copenhagen, Denmark
Russian Federation
City Multifield Hospital #2, City Center of Intensive Pulmonology and Thoracic Surgery
St. Petersburg, Russian Federation, 194354
St. Petersburg Pavlov State Medical University
St. Petersburg, Russian Federation, 197022
Sponsors and Collaborators
Active Biotech AB
Investigators
Study Director: Suzanne Kilany Active Biotech AB
More Information

Responsible Party: Active Biotech AB
ClinicalTrials.gov Identifier: NCT00132379     History of Changes
Other Study ID Numbers: 05762003
First Posted: August 22, 2005    Key Record Dates
Last Update Posted: August 27, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Antibodies, Monoclonal
Immunoconjugates
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs