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

Alternate Title

Interferon gamma in Treating Patients With Recurrent or Metastatic Melanoma or Other Solid Tumors

Basic Trial Information

Objectives

I.  Determine the maximum tolerated dose of intratumoral adenovirus vector 
containing interferon gamma in patients with locally recurrent or metastatic 
melanoma or other solid tumors.

II. Assess the safety and tolerability of this regimen in this patient 
population.

III.  Determine the local or distant antitumor effect of this regimen in these 
patients.

IV.  Evaluate the biological and immunological effects of this regimen and the 
extent of local interferon gamma expression in these patients.

Entry Criteria

Disease Characteristics:

Histologically confirmed malignant melanoma or other solid tumor not amenable
to curative therapy
 Locally recurrent OR
 Metastatic disease
 
Suitable cutaneous or nodal sites for intratumoral injection

No uncontrolled CNS metastases
 Brain metastases allowed if stereotactically or surgically treated, well
  controlled, and not requiring systemic corticosteroids

Prior/Concurrent Therapy:

Biologic therapy:
 At least 3 weeks since prior immunotherapy for melanoma
 No other concurrent immunotherapy

Chemotherapy:
 At least 3 weeks since prior systemic chemotherapy for melanoma
 No concurrent chemotherapy

Endocrine therapy:
 No concurrent systemic corticosteroids

Radiotherapy:
 No concurrent radiotherapy

Surgery:
 Not specified

Other:
 No other concurrent investigational therapy

Patient Characteristics:

Age:
 18 and over

Performance status:
 ECOG 0-2

Life expectancy:
 At least 3 months

Hematopoietic:
 Hemoglobin at least 10.0 g/dL
 WBC at least 3,000/mm3
 Platelet count at least 100,000/mm3

Hepatic:
 Bilirubin no greater than 2 times upper limit of normal (ULN)
 SGPT/SGOT no greater than 3 times ULN

Renal:
 Creatinine no greater than 2 times ULN

Other:
 HIV negative
 No active systemic infection
 No other serious systemic medical conditions
 Positive delayed hypersensitivity reaction to at least one of the following
  antigens: tetanus, candida, mumps, or trichophyton
 Not pregnant
 Fertile patients must use effective contraception during and for 3 months
  after study

Expected Enrollment

A minimum of 12 patients will be accrued for this study.

Outline

This is a dose escalation study.

Patients receive adenovirus interferon gamma intratumorally on days 1, 8, and 
15. Patients achieving tumoral response may receive additional courses of 
therapy at the discretion of the investigator.

Cohorts of at least 3 patients receive escalating doses of adenovirus 
interferon gamma until the maximum tolerated dose (MTD) is determined. The MTD 
is defined as the dose preceding that at which 3 of 6 patients experience dose 
limiting toxicity.

Patients are followed for 3 weeks after treatment.

Trial Contact Information

Trial Lead Organizations

James P. Wilmot Cancer Center at University of Rochester Medical Center

Joseph Rosenblatt, MD, Protocol chair		Ph: 305-243-9528 Email: jrosenblatt@med.miami.edu

Registry Information
Official Title		Phase I Trial of Immunotherapy with Adenovirus-Interferon- Gamma (TG1041) in Patients with Malignant Melanoma
Trial Start Date		1999-04-14
Registered in ClinicalTrials.gov		NCT00004016
Date Submitted to PDQ		1999-07-29
Information Last Verified		2001-09-01
NCI Grant/Contract Number		CA11198

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