drugset / Trial / NCT00002994
Interleukin-2 Plus Monoclonal Antibody Therapy in Treating Patients With Solid Tumors
Phase 1
Completed
355 enrolled
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 1997-07
- Primary completion
- 2000-03
- Completion
- 2002-04
Publications
- Results Fleming GF, Meropol NJ, Rosner GL, Hollis DR, Carson WE 3rd, Caligiuri M, Mortimer J, Tkaczuk K, Parihar R, Schilsky RL, Ratain MJ. A phase I trial of escalating doses of trastuzumab combined with daily subcutaneous interleukin 2: report of cancer and leukemia group B 9661. Clin Cancer Res. 2002 Dec;8(12):3718-27.
- Results Fleming GF, Meropol NJ, Hollis DR, et al.: Phase I trial of recombinant human anti-Her2 monoclonal antibody (H) plus low-dose interleukin-2 (IL-2) in patients with solid tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A710, 1999.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trastuzumab | Monoclonal antibody | 1 mg/kg | — |
| Subject | Trastuzumab | Monoclonal antibody | 8 mg/kg | — |
| Subject | aldesleukin | Protein / enzyme biologic | 1e+06 unknown | Subcutaneous |