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Interleukin-12, Paclitaxel, and Trastuzumab in Treating Patients With Solid Tumors

NCT00028535 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2013-06-04

No results posted yet for this study

Summary

Phase I trial to study the effectiveness of interleukin-12, paclitaxel, and trastuzumab in treating patients who have solid tumors. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining interleukin-12, chemotherapy, and monoclonal antibody therapy may kill more tumor cells.

Conditions

  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Recurrent Endometrial Carcinoma
  • Recurrent Gastric Cancer
  • Recurrent Non-small Cell Lung Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Recurrent Small Cell Lung Cancer

Interventions

BIOLOGICAL

trastuzumab

Given IV

DRUG

paclitaxel

Given IV

BIOLOGICAL

recombinant interleukin-12

Given SC

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • William Carson · Ohio State University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-11-30
Primary Completion
2009-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00028535 on ClinicalTrials.gov