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Interleukin-2 Gene or Methotrexate in Treating Patients With Recurrent or Refractory Stage III or Stage IV Head and Neck Cancer

NCT00006033 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2013-05-30

No results posted yet for this study

Summary

RATIONALE: Inserting the gene for interleukin-2 into head and neck cancer cells may make the body build an immune response to kill the tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether the interleukin-2 gene is more effective than methotrexate for advanced head and neck cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of the interleukin-2 gene with that of methotrexate in treating patients who have recurrent or refractory stage III or stage IV head and neck cancer.

Conditions

Interventions

BIOLOGICAL

gene therapy

BIOLOGICAL

interleukin-2 gene

DRUG

methotrexate

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Thomas V. McCaffrey, MD, PhD · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Purpose
TREATMENT

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-06-30
Completion
2004-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00006033 on ClinicalTrials.gov