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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

Phase 1
18 Years
Not Enrolling
Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Pancreatic Cancer

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Trial Information

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

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

- 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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

56 days after start of first treatment cycle

Safety Issue:


Principal Investigator

Suzanne Kilany

Investigator Role:

Study Director

Investigator Affiliation:

Active Biotech AB


United States: Food and Drug Administration

Study ID:




Start Date:

April 2003

Completion Date:

December 2006

Related Keywords:

  • Non-Small-Cell Lung Carcinoma
  • Renal Cell Carcinoma
  • Pancreatic Cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Lung Neoplasms
  • Pancreatic Neoplasms
  • Adenocarcinoma, Clear Cell
  • Adenomyoepithelioma



Fox Chase Cancer Center Philadelphia, Pennsylvania  19111