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NHS-IL12 for Solid Tumors

NCT01417546 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2021-10-18

No results posted yet for this study

Summary

Background:

\- The experimental drug NHS-IL12 may help the immune system become more active and kill cancer cells that have not responded to standard treatments. NHS-IL12 has been designed to cause less severe side effects than other anticancer drugs, and may be more effective. More research is needed to test NHS-IL12 in people who have solid tumors that have not responded to treatment.

Objectives:

\- To test the safety and effectiveness of NHS-IL12 as a treatment for solid tumors which have not responded to standard treatments.

Eligibility:

\- Individuals at least 18 years of age with solid tumors that have not responded to standard treatments.

Design:

* Participants will be screened with a medical history, physical exam, blood and urine tests, and imaging studies.
* Participants will receive NHS-IL12 injection every 4 weeks, and will stay in the hospital for at least one day to be monitored with frequent blood tests.
* Participants will have periodic blood samples taken before treatment and during the first week after treatment for the first two cycles. They will then have blood samples taken before treatment for the rest of the cycles.

Conditions

  • Epithelial Neoplasms, Malignant
  • Epithelial Tumors, Malignant
  • Malignant Mesenchymal Tumor

Interventions

DRUG

NHS-IL-12

NHS-IL12 is an investigational agent supplied to investigators by the manufacturer EMD Serono, Inc.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • James L Gulley, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-12
Primary Completion
2021-06-02
Completion
2021-10-14
FDA Drug
Yes

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 NCT01417546 on ClinicalTrials.gov