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A Pilot Study of Low-Dose Interleukin-2 Plus Recombinant Human Anti-HER2 Monoclonal Antibody in Solid Tumors

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Pilot Study of Low-Dose Interleukin-2 Plus Recombinant Human Anti-HER2 Monoclonal Antibody in Solid Tumors

OBJECTIVES: I. Determine the toxic effects of humanized anti-HER2 monoclonal antibodies when
administered in combination with interleukin-2 (IL-2) in patients with solid tumors. II.
Measure in vitro cytotoxicity using peripheral blood mononuclear cells, plasma, and target
cell lines that express HER2 in this patient population. III. Phenotypically characterize
effector cells at the time of antibody administration and 24 hours after three days of
intermediate dose IL-2 pulsing in these patients. IV. Measure antitumor response in these

OUTLINE: Cohorts of 6 patients are enrolled at 4 antibody dose levels. After at least 6
patients have been treated on study for at least 30 days, the next dose level may be
initiated provided that fewer than 2 of the first 6 evaluable patients experience dose
limiting toxicity (DLT) related to either the antibody or the combination of antibody with
interleukin-2 (IL-2). If 2 or more patients experience DLT, the next cohort is enrolled at
the antibody dose midway between the current and previous dose levels. An additional 6
patients are entered at the maximum tolerated dose. On course 1, patients receive IL-2
subcutaneously (SQ) daily on days 1-7 and humanized anti-HER-2 monoclonal antibodies IV over
90 minutes on day 7. Patients receive intermediate dose pulsed IL-2 SQ on days 8-10 and low
dose IL-2 SQ on days 11-20. On course 2 and all subsequent courses, patients receive
humanized anti-HER2 monoclonal antibodies IV immediately prior to IL-2 (SQ) on day 1 and
intermediate dose pulsed IL-2 (SQ) on days 1-3. Patients receive low dose IL-2 (SQ) on days
4-14. Treatment may be delayed up to 7 days to allow for recovery and for tumor restaging,
but daily low dose IL-2 is continued in this interval. Patients are followed at 4 weeks and
then every 8 weeks until progression or death.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed nonhematologic malignancy Refractory
disease or disease for which no effective standard therapy exists HER2 overexpression in
tumor tissue Measurable or evaluable disease No CNS metastases Hormone receptor status:
Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance
status: CALGB 0-1 Life expectancy: At least 3 months Hematopoietic: Absolute granulocyte
count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater
than 1.5 times normal SGOT no greater than 5 times normal Alkaline phosphatase no greater
than 5 times normal Renal: BUN no greater than 1.5 times normal Creatinine no greater than
1.5 times normal Cardiovascular: No uncontrolled or severe cardiac disease LVEF at least
45% by MUGA or echocardiogram Other: HIV negative No immunologic disease (e.g., autoimmune
disease) Negative viral hepatitis antibodies No psychiatric conditions which would prevent
compliance with treatment Not pregnant or nursing Fertile patients must use effective
contraception No active uncontrolled bacterial, viral, or fungal infection Prior or
concurrent malignancy allowed

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior interleukin-2 (IL-2) and/or herceptin
allowed No concurrent immunosuppressive drugs or other immunomodulators (other than IL-2)
Chemotherapy: At least 6 weeks since nitrosoureas, melphalan, or mitomycin More than 4
weeks since other chemotherapy Endocrine therapy: No concurrent corticosteroids
Radiotherapy: More than 4 weeks since prior radiotherapy Surgery: At least 4 weeks since
major surgery

Type of Study:


Study Design:

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

Outcome Measure:


Outcome Description:

toxicity of anti-Her2 MoAB given in combo w/ IL-2

Outcome Time Frame:

Cycle 1 1st MoAb tx (Day 7), then Day 1 of ea subsequent cycle

Safety Issue:


Principal Investigator

Gini F. Fleming, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago


United States: Food and Drug Administration

Study ID:




Start Date:

July 1997

Completion Date:

April 2002

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms



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Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Rhode Island HospitalProvidence, Rhode Island  02903
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CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
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University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
Mount Sinai Medical Center, NYNew York, New York  10029
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
North Shore University HospitalManhasset, New York  11030
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
University of Illinois at Chicago Health Sciences CenterChicago, Illinois  60612
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330