NCT00132379

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2005

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

August 27, 2014

Status Verified

August 1, 2014

Enrollment Period

1.1 years

First QC Date

August 19, 2005

Last Update Submit

August 26, 2014

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

  • Side effect profile (based on blood pressure, body temperature, and laboratory tests)

    Day 56 (Day 115 if undergo cycles 3/4)

Secondary Outcomes (5)

  • Pharmacokinetic parameters

    Days 1 and 4 of cycles 1 and 2

  • Immunological response

    Day 56 (Day 115 if undergo cycles 3/4)

  • Changes in anti-SEA/E-120 levels

    Day 56 (Day 115 if undergo cycles 3/4)

  • Objective response rate

    Day 56 (Day 115 if undergo cycles 3/4)

  • Time to progression and Survival

    Followed for up to 1 year

Study Arms (1)

1

EXPERIMENTAL
Drug: ABR-217620Drug: docetaxel

Interventions

ABR-217620DRUG

10.3, 16.5 or 22 mcg/kg, IV, daily 5 minute bolus injection for 4 consecutive day per cycle; up to 6 cycles

Also known as: CD3; 5T4FabV18-SEA/E-120; naptumomab estafenatox; Anyara
1
docetaxelDRUG

75mg/m\^2, IV, single 60 minute infusion, beginning on Day 5 then every third week

Also known as: Taxotere
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Onkologisk Klinik, Rigshospitalet

Copenhagen, Denmark

Location

City Multifield Hospital #2, City Center of Intensive Pulmonology and Thoracic Surgery

Saint Petersburg, 194354, Russia

Location

St. Petersburg Pavlov State Medical University

Saint Petersburg, 197022, Russia

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

naptumomab estafenatoxCD3 ComplexDocetaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antigens, Differentiation, T-LymphocyteAntigens, DifferentiationAntigens, SurfaceAntigensBiological FactorsBiomarkersTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Suzanne Kilany

    Active Biotech AB

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2005

First Posted

August 22, 2005

Study Start

November 1, 2005

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

August 27, 2014

Record last verified: 2014-08

Locations

DK(1)RU(2)US(1)