Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed 18 and over NCI, Pharmaceutical / Industry DFCI-99081 VALENTIS-DFCI-99081, NCI-G99-1578, NCT00004070

Objectives

I. Determine the safety and tolerability of interleukin-12 gene in patients 
with unresectable, recurrent, or refractory squamous cell carcinoma of the 
head and neck. 

II. Evaluate the efficacy of this regimen in these patients.

Entry Criteria

Disease Characteristics:

Histologically proven unresectable, recurrent, or refractory squamous cell
carcinoma of the head and neck
 Primarily stage III or IV
 Tumor accessible to direct injection

No tumor involving major blood vessels or obstructing airway

Prior/Concurrent Therapy:

Biologic therapy:
 No prior viral based gene therapy, recombinant DNA products, or bacterial
  plasmids

Chemotherapy:
 At least 28 days since prior chemotherapy
 No concurrent chemotherapy
 No chemotherapy during follow up period

Endocrine therapy:
 No concurrent corticosteroids

Radiotherapy:
 At least 28 days since prior radiotherapy
 No concurrent radiotherapy
 No radiotherapy during follow up period

Surgery:
 At least 28 days since prior surgery
 No concurrent surgery
 No surgery during follow up period

Other:
 At least 30 days since prior investigational drugs
 No concurrent high dose nonsteroidal antiinflammatory drugs
 No concurrent immunosuppressive drugs

Patient Characteristics:

Age:
 18 and over

Performance status:
 Karnofsky 70-100%

Life expectancy:
 At least 3 months

Hematopoietic:
 WBC at least 3,000/mm3
 Platelet count at least 50,000/mm3

Hepatic:
 No prior or concurrent active liver disease 
 SGOT and SGPT no greater than 3 times upper limit of normal (ULN)
 
Renal:
 Creatinine no greater than 1.5 times ULN

Cardiovascular:
 No New York Heart Association class III or IV heart disease 

Pulmonary:
 No respiratory disease that sufficiently influences oxygenation of arterial
  blood

Other:
 At least 2 weeks since prior infection
 No concurrent infection
 No active or clinically relevant viral illness
 No other malignancies requiring treatment during this study
 No prior autoimmune disease (e.g., rheumatic disease, Crohn's disease)
 No allergy to polyvinylpyrrolidone (PVP) or related products
 No prior psychiatric disability 
 No prior seizures
 Not pregnant or nursing
 Negative pregnancy test
 Fertile patients must use effective contraception

Expected Enrollment

A total of 28-34 patients will be accrued for this study.

Outline

This is a multicenter study.

Patients receive interleukin-12 gene by intratumoral injection twice during 
week 1 and once weekly during weeks 2-7 in the absence of disease progression 
or unacceptable toxicity. 

Trial Contact Information

Trial Lead Organizations

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

A. Dimitrios Colevas, MD, Protocol chair		Ph: 301-496-1106 Email: colevasd@ctep.nci.nih.gov

Registry Information
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)
Trial Start Date		1999-07-14
Registered in ClinicalTrials.gov		NCT00004070
Date Submitted to PDQ		1999-08-24
Information Last Verified		2001-01-01
NCI Grant/Contract Number		CA06516