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Interleukin-2 Plus Monoclonal Antibody Therapy in Treating Patients With Solid Tumors

NCT00002994 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 355

Last updated 2016-06-28

No results posted yet for this study

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.

Conditions

  • Unspecified Adult Solid Tumor, Protocol Specific

Interventions

BIOLOGICAL

interleukin 2

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

BIOLOGICAL

rhuMAb

90 min IV infusion day 7 of each cycle

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Alliance for Clinical Trials in Oncology

    lead OTHER

Principal Investigators

  • Gini Fleming, MD · University of Chicago

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-07-31
Primary Completion
2000-03-31
Completion
2002-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00002994 on ClinicalTrials.gov