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


Phase 1
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin), Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

Inclusion 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

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Joseph D. Rosenblatt, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067234

NCT ID:

NCT00004016

Start Date:

April 1999

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • Unspecified Adult Solid Tumor, Protocol Specific
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • unspecified adult solid tumor, protocol specific
  • Melanoma
  • Neoplasms

Name

Location

University of Rochester Cancer CenterRochester, New York  14642