Interleukin-2 Plus Monoclonal Antibody Therapy in Treating Patients With Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill solid tumor
      cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver
      tumor-killing substances to them without harming normal cells.

      PURPOSE: Pilot study to examine the effectiveness of interleukin-2 plus monoclonal antibody
      in treating patients who have solid tumors.
    

Detailed description: 
      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
      patients.

      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.
    

Intervention name(s): interleukin 2; rhuMAb
Intervention type(s): Biological; Biological
Intervention description(s): low dose: 1 million IU/square meter subq injection q day days 1-7 and 11-20 cycle 1; days 4-14 subsequent cycles Intermediate dose: 12 million IU/square meter subq injection on days 8-10 of cycle 1; days 1-3 of subsequent cycles; 90 min IV infusion day 7 of each cycle
Intervention MeSH terms: Interleukin-2
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific