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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004016
First Posted: April 15, 2004
Last Update Posted: June 6, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
University of Rochester
  Purpose

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 Intervention Phase
Melanoma (Skin) Unspecified Adult Solid Tumor, Protocol Specific Biological: recombinant interferon gamma Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Trial of Immunotherapy With Adenovirus-Interferon- Gamma (TG1041) in Patients With Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Study Start Date: April 1999
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004016


Locations
United States, New York
University of Rochester Cancer Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Cancer Institute (NCI)
Investigators
Study Chair: Joseph D. Rosenblatt, MD University of Miami Sylvester Comprehensive Cancer Center
  More Information

ClinicalTrials.gov Identifier: NCT00004016     History of Changes
Other Study ID Numbers: CDR0000067234
P30CA011198 ( U.S. NIH Grant/Contract )
URCC-U2698
TRANSGENE-TG1041.01
NCI-G99-1559
First Submitted: November 1, 1999
First Posted: April 15, 2004
Last Update Posted: June 6, 2013
Last Verified: June 2013

Keywords provided by University of Rochester:
stage III melanoma
stage IV melanoma
recurrent melanoma
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interferons
Interferon-gamma
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents