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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00004016
First received: November 1, 1999
Last updated: June 5, 2013
Last verified: June 2013

November 1, 1999
June 5, 2013
April 1999
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Complete list of historical versions of study NCT00004016 on ClinicalTrials.gov Archive Site
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Interferon Gamma in Treating Patients With Recurrent or Metastatic Melanoma or Other Solid Tumors
Phase I Trial of Immunotherapy With Adenovirus-Interferon- Gamma (TG1041) in Patients With Malignant Melanoma

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.

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.

Interventional
Phase 1
Primary Purpose: Treatment
  • Melanoma (Skin)
  • Unspecified Adult Solid Tumor, Protocol Specific
Biological: recombinant interferon gamma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004016
CDR0000067234, P30CA011198, URCC-U2698, TRANSGENE-TG1041.01, NCI-G99-1559
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University of Rochester
National Cancer Institute (NCI)
Study Chair: Joseph D. Rosenblatt, MD University of Miami Sylvester Comprehensive Cancer Center
University of Rochester
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP