NCT00056537

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2003

Typical duration for phase_1

Geographic Reach
3 countries

3 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

March 16, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2003

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2003

Completed
3.7 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

3.7 years

First QC Date

March 16, 2003

Last Update Submit

August 26, 2014

Conditions

Non-Small-Cell Lung CarcinomaRenal Cell CarcinomaPancreatic Cancer

Outcome Measures

Primary Outcomes (1)

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

    56 days after start of first treatment cycle

Secondary Outcomes (5)

  • Safety profile

    During or after first treatment cycle, second treatment cycle, later cycles if available

  • Pharmacokinetic parameters

    Days 1 and 5 of each cycle

  • Immunological response

    Days 28 and 56 of first and second treatment cycles, later cycles if available

  • Objective response rate

    Days 28 and 56 of first and second treatment cycles, later cycles if available

  • Time to progression and Survival

    Followed for up to 2 years

Study Arms (1)

1

EXPERIMENTAL
Drug: ABR-217620

Interventions

ABR-217620DRUG

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

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

You may not qualify if:

  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Det Norske Radiumhospitalet

Oslo, Norway

Location

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

Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungCarcinoma, Renal CellPancreatic Neoplasms

Interventions

naptumomab estafenatoxCD3 Complex

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesDigestive System NeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Antigens, Differentiation, T-LymphocyteAntigens, DifferentiationAntigens, SurfaceAntigensBiological FactorsBiomarkers

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

March 16, 2003

First Posted

March 18, 2003

Study Start

April 1, 2003

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

August 27, 2014

Record last verified: 2014-08

Locations

GB(1)US(1)NO(1)