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

Sponsor

University of Rochester (Other)

Overall Status

Completed

CT.gov ID

NCT00004016

Collaborator

National Cancer Institute (NCI) (NIH)

Location

Study Details

Study Description

Brief Summary

RATIONALE: Interferon gamma may interfere with the growth of cancer cells and may be an effective treatment for melanoma and solid tumors.

PURPOSE: Phase I trial to study the effectiveness of interferon gamma in treating patients with recurrent or metastatic melanoma or other solid tumors.

Condition or Disease	Intervention/Treatment	Phase
Melanoma (Skin) Unspecified Adult Solid Tumor, Protocol Specific	Biological: recombinant interferon gamma	Phase 1

Detailed Description

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.

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.

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

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

Phase I Trial of Immunotherapy With Adenovirus-Interferon- Gamma (TG1041) in Patients With Malignant Melanoma

Study Start Date :

Apr 1, 1999

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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

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