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Head and Neck CancerPhase 1/2NCT00004070

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

A Phase 1/2 study testing IL-12 in people with Head and Neck Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
IL-12
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
2 sitesUnited States
Study dates
Jul 1999to Dec 2000
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official 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)

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.

Read the detailed description

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.

Being tested
IL-12
Keywords
recurrent metastatic squamous neck cancer with occult primary, metastatic squamous neck cancer with occult primary squamous cell carcinoma, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IL-12Biological

    Also called NFSK, CLMF, P35, Interleukin-12 gene

Study groups in NCT00004070
Study groupRoleWhat they receive
IL-12 Injection 3mg/ml [Phase I]ExperimentalThe dosing schedule will consist of eight injections 3 mg/ml of formulated plasmid over a seven week period.
Receives: Biological: IL-12
IL-12 Injection 6mg/ml [Phase I]ExperimentalThe dosing schedule will consist of eight injections 6mg/ml of formulated plasmid over a seven week period.
Receives: Biological: IL-12
IL-12 Injection MTD [Phase II]ExperimentalThe dosing schedule will consist of eight injections over a seven week period of formulated plasmid at the MTD established in the phase I portion.
Receives: Biological: IL-12

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Assessed during therapy up to 7 weeks.

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

    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).

    Measured: Assessed during therapy up to 7 weeks.

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

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

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

Secondary outcomes (3)

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

    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).

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

  2. Response [Phase II]

    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.

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

  3. Overall Survival (OS) [Phase II]

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2004 (estimated)
  2. Study startJul 1999
  3. Primary completionNov 2000
  4. Study completionDec 2000

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
This is a non-randomize phase I/II where patients are directly assigned treatment.
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00004070
Sponsor's protocol ID
99-081
Other IDs
P30CA006516, VALENTIS-DFCI-99081, NCI-G99-1578, CDR0000067274
Status last verified
Apr 2017
First submitted
10 Dec 1999
Last updated
20 Apr 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IL-12 in people with Head and Neck Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) [Phase I] (time frame: Assessed during therapy up to 7 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00004070.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.

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