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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



Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157-1082
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Medical University of South Carolina Charleston, South Carolina  29425-0721
Rhode Island Hospital Providence, Rhode Island  02903
Vermont Cancer Center Burlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
University of California San Diego Cancer Center La Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
Barnes-Jewish Hospital Saint Louis, Missouri  63110
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
CCOP - North Shore University Hospital Manhasset, New York  11030
State University of New York - Upstate Medical University Syracuse, New York  13210
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer Center Memphis, Tennessee  38103
Mount Sinai Medical Center, NY New York, New York  10029
New York Presbyterian Hospital - Cornell Campus New York, New York  10021
Dana-Farber Cancer Institute Boston, Massachusetts  02115
North Shore University Hospital Manhasset, 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 Center Chicago, Illinois  60612
University of Nebraska Medical Center Omaha, Nebraska  68198-3330