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

This study has been completed.
Sponsor:
Information provided by:
Active Biotech AB
ClinicalTrials.gov Identifier:
NCT00056537
First received: March 16, 2003
Last updated: March 5, 2008
Last verified: March 2008
  Purpose

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.


Condition Intervention Phase
Non-Small-Cell Lung Carcinoma
Renal Cell Carcinoma
Pancreatic Cancer
Drug: ABR-217620
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Active Biotech AB:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety profile [ Time Frame: During or after first treatment cycle, second treatment cycle, later cycles if available ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic parameters [ Time Frame: Days 1 and 5 of each cycle ] [ Designated as safety issue: No ]
  • Immunological response [ Time Frame: Days 28 and 56 of first and second treatment cycles, later cycles if available ] [ Designated as safety issue: Yes ]
  • Objective response rate [ Time Frame: Days 28 and 56 of first and second treatment cycles, later cycles if available ] [ Designated as safety issue: No ]
  • Time to progression and Survival [ Time Frame: Followed for up to 2 years ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: April 2003
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
Other Name: CD3; 5T4FabV18-SEA/E-120; naptumomab estafenatox; Anyara

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00056537

Locations
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Norway
Det Norske Radiumhospitalet
Oslo, Norway
United Kingdom
Paterson Institute for Cancer Research, Christie Hospital NHS Trust and Research Institute
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Active Biotech AB
Investigators
Study Director: Suzanne Kilany Active Biotech AB
  More Information

No publications provided

Responsible Party: Lars M Nilsson, DVM / VP Regulatory & Quality Affairs, Active Biotech Research
ClinicalTrials.gov Identifier: NCT00056537     History of Changes
Other Study ID Numbers: 01762001
Study First Received: March 16, 2003
Last Updated: March 5, 2008
Health Authority: United States: Food and Drug Administration
Norway: Norwegian Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Carcinoma, Renal Cell
Kidney Neoplasms
Lung Neoplasms
Pancreatic Neoplasms
Adenocarcinoma, Clear Cell
Adenomyoepithelioma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neoplasms, Complex and Mixed

ClinicalTrials.gov processed this record on April 22, 2014