Interferon Gamma in Treating Patients With Recurrent or Metastatic Melanoma or Other Solid Tumors
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Melanoma (Skin); Unspecified Adult Solid Tumor, Protocol Specific
Intervention: recombinant interferon gamma (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: James P. Wilmot Cancer Center Official(s) and/or principal investigator(s):
Joseph D. Rosenblatt, MD, Study Chair, Affiliation: Sylvester Cancer Center
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.
Clinical Details
Official title: Phase I Trial of Immunotherapy With Adenovirus-Interferon- Gamma (TG1041) in Patients With Malignant Melanoma
Study design: Treatment
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
University of Rochester Cancer Center, Rochester, New York 14642, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: April 1999
Last updated: May 23, 2008
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