Skip to main content
OpenTrials
Completed

NCT Number: NCT00004070

Gene Therapy in Treating Patients With Unresectable, Recurrent, or Refractory Head and Neck Cancer

Participant with squamous cell cancer of head and neck are invited to participate in this study. In this study the investigators will be Inserting the gene for interleukin-12 into a person's cancer cells with the anticipation to make the body build an immune response to kill more tumor cells.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Head and Neck Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Loading trial locations.

About this study

This is a Phase I/II trial to study the effectiveness of gene therapy in treating patients who have unresectable, recurrent, or refractory head and neck cancer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Females must be non-pregnant and non-lactating and either surgically sterile (via hysterectomy or bilateral tubal ligation), at least one year post-menopausal, or using acceptable methods of contraception for the duration of the study.
  • Male subjects must be surgically sterile or using an acceptable method of contraception for the duration of the study.
  • Disease: biopsy-proven unresectable or recurrent/refractory squamoussell_eareinoma_of_the:head-and-neck-(usualLy -Stage-Di-or-IV) -
  • Tumor accessible to direct injection
  • Karnofsky performance of at least 70%
  • Life expectancy of at least three months
  • Able to give written informed consent

Exclusion criteria

  • Infection (concurrent or within previous 2 weeks)
  • Active or clinically-relevant viral illnesses.
  • Use of corticosteroids, high-dose non-steroidal antiinflammatory, or immunosuppressive drugs
  • Chemotherapy, radiotherapy or immunotherapy within 28 days of study entry or during the course of study
  • Respiratory disease sufficient to influence oxygenation of arterial blood
  • Active liver disease with transaminases >3 times the upper limit of normal
  • Previous history of liver disease
  • NYHA Class EU or greater heart failure
  • Serum creatinine of greater than 1.5 times the upper limit of normal
  • Polymorphonuclear neutrophilic leukocyte count <3,000/mm3
  • Platelet count <50,000/mm 3
  • Tumor involving major blood vessels or obstructing the airway
  • Previous treatment with viral-based gene therapy, recombinant DNA products, or bacterial plasmids
  • Use of an investigational drug within 30 days of screening
  • Other malignancies requiring treatment during the study
  • Scheduled surgical resection
  • History of autoimmune disease, including rheumatic disease, Crohn's disease, etc. ,
  • Known allergy to polyvinylpyrrofidone (PVP) or related products
  • History of psychiatric disabilities or seizures.

Treatment and study plan

IL-12

Biological

Other names: NFSK, CLMF, P35, Interleukin-12 gene

Primary outcomes

  1. Maximum Tolerated Dose (MTD) [Phase I]

    Time frame: Assessed during therapy up to 7 weeks.

    The MTD of IL-12 gene medicine is determined by the number of participants who experience a dose limiting toxicity (DLT). The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed in the two dose levels planned then evaluation of a third escalation will be considered. If the MTD is not reached, the dose selected for use in the phase II portion will be defined as the maximum volume that can be reasonably and safely injected into the tumor.

  2. Dose Limiting Toxicity (DLT) [Phase I]

    Time frame: Assessed during therapy up to 7 weeks.

    A DLT was defined as grade 4 hematologic toxicity greater than 5 days duration or grade 3 or higher non-hematologic toxicity based on NCI common toxicity criteria (CTCAEv2).

  3. Grade 3-4 Toxicity Rate [Phase II]

    Time frame: Assessed until last scheduled on-study visit up to visit 12/day 112.

    All Grade 3-4 events based on CTCAEv2 as reported on case report forms.

Secondary outcomes

  1. Time to Progressive Disease (TTP) [Phase III]

    Time frame: Measurement by CT occurs up to the earliest of progression, death or 4 months after enrollment of last patient.

    Time to progression based on the Kaplan-Meier method is defined as the duration of time from study entry to documented first observation of progressive disease (PD).

    Time to progression based on the Kaplan-Meier method is defined as the duration of time from study entry to documented first observation of progressive disease (PD).

  2. Response [Phase II]

    Time frame: Measurement by CT occurs up to visit 12/day 112.

    Best response on treatment classifies patients into 4 groups: complete response (CR) is complete disappearance of all signs, symptoms, biochemical and radiographic evidence of tumor for a minimum of 1 month; partial response (PR) is >/=50% decreases in tumor area for at least 4 weeks without an increase in size of other lesions of >25% or appearance of new lesions; progressive disease (PD) is >50% increase in size of any lesion present at baseline or after response, or appearance of a new lesion; and stable disease (SD) is neither PR or better nor PD.

  3. Overall Survival (OS) [Phase II]

    Time frame: Measurement by CT occurs up to the earliest of progression, death or 4 months after enrollment of last patient.

    OS is defined as the duration of time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Multi-Center, Open-Label, Multiple Administration, Rising Dose Study of the Safety, Tolerability, and Efficacy of IL-12 Gene Medicine in Patients With Unresectable or Recurrent/Refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Important dates

Study start
1999
Primary completion
2000
Study completion
2000
First posted
Jun 4, 2004
Registry last updated
Apr 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.