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Vaccine Therapy in Treating Patients With Metastatic Melanoma

Primary Purpose

Melanoma (Skin)

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
recombinant vaccinia-TRICOM vaccine
Sponsored by
Herbert Irving Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma, recurrent melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed metastatic non-resectable cutaneous, subcutaneous, or lymph node malignant melanoma Lesion(s) must be accessible to percutaneous injection Measurable lesion(s) At least 1.0 cm Previously treated brain metastases with no evidence of disease or edema on MRI or CT scan allowed At least 6 weeks since prior definitive therapy (surgery or radiotherapy) No untreated or edematous metastatic brain lesions or leptomeningeal disease No ascites or pleural effusions PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Absolute granulocyte count at least 3,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Direct bilirubin no greater than 1.5 mg/dL Transaminases no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN No severe coagulation disorder with PT/PTT greater than 2 times normal (without anticoagulation medications) No hepatic insufficiency No alcoholic cirrhosis Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 60 mL/min No renal insufficiency Cardiovascular: No congestive heart failure No serious cardiac arrhythmias No evidence of recent prior myocardial infarction on EKG No clinical coronary artery disease Pulmonary: No chronic obstructive pulmonary disease Immunologic: No prior eczema HIV negative No immunocompromising conditions, (e.g., active autoimmune disease, leukemia, lymphoma, skin diseases, or open wounds) No clinical or laboratory evidence of an underlying immunosuppressive disorder No active or chronic infections No significant allergy or hypersensitivity to eggs Other: No active seizure disorders No other malignancy within the past 2 years except stage I cervical cancer or basal cell skin cancer, provided the tumor has been successfully treated and patient is currently disease free No evidence of bone marrow toxicity No other concurrent medical illness that would preclude study No other contraindications to vaccinia virus administration No encephalitis Must be able to avoid close contact with children under 3 years of age; pregnant women; individuals with prior or active eczema or other open skin conditions; or immunosuppressed individuals for 7-10 days after each vaccination Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Prior vaccinia immunization required (e.g., smallpox vaccination) More than 8 weeks since prior immunotherapy and recovered No prior therapy with live vaccinia virus vector Chemotherapy: More than 4 weeks since prior chemotherapy and recovered Endocrine therapy: At least 4 weeks since prior systemic corticosteroids No concurrent systemic corticosteroids No concurrent steroids Radiotherapy: See Disease Characteristics More than 2 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics More than 4 weeks since prior surgery for primary tumor or metastatic lesions and recovered Other: No concurrent immunosuppressive drugs

Sites / Locations

  • Herbert Irving Comprehensive Cancer Center at Columbia University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 10, 2001
Last Updated
December 17, 2013
Sponsor
Herbert Irving Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00022568
Brief Title
Vaccine Therapy in Treating Patients With Metastatic Melanoma
Official Title
A Phase I Trial of Intra Lesional rV-Tricom Vaccine in the Treatment of Malignant Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2003
Overall Recruitment Status
Unknown status
Study Start Date
August 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Herbert Irving Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.
Detailed Description
OBJECTIVES: Determine the maximum tolerated dose of recombinant vaccinia-TRICOM vaccine in patients with metastatic melanoma. Determine the clinical toxic effects of this vaccine in these patients. Determine the safety of this vaccine in these patients. Determine the clinical response of these patients to this vaccine. Determine evidence of host anti-melanoma immune reactivity in these patients after treatment with this vaccine. OUTLINE: This is a dose-escalation study. Patients receive recombinant vaccinia-TRICOM vaccine once every 4 weeks for a total of 3 vaccinations. Patients with stable or responding disease may receive an additional course of vaccinations. Cohorts of 3-6 patients receive escalating doses of recombinant vaccinia-TRICOM vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Quality of life is assessed at baseline, at each vaccine administration, and at study completion. Patients are followed at 3 months. PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study within 6-12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
stage IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
recombinant vaccinia-TRICOM vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic non-resectable cutaneous, subcutaneous, or lymph node malignant melanoma Lesion(s) must be accessible to percutaneous injection Measurable lesion(s) At least 1.0 cm Previously treated brain metastases with no evidence of disease or edema on MRI or CT scan allowed At least 6 weeks since prior definitive therapy (surgery or radiotherapy) No untreated or edematous metastatic brain lesions or leptomeningeal disease No ascites or pleural effusions PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Absolute granulocyte count at least 3,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Direct bilirubin no greater than 1.5 mg/dL Transaminases no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN No severe coagulation disorder with PT/PTT greater than 2 times normal (without anticoagulation medications) No hepatic insufficiency No alcoholic cirrhosis Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 60 mL/min No renal insufficiency Cardiovascular: No congestive heart failure No serious cardiac arrhythmias No evidence of recent prior myocardial infarction on EKG No clinical coronary artery disease Pulmonary: No chronic obstructive pulmonary disease Immunologic: No prior eczema HIV negative No immunocompromising conditions, (e.g., active autoimmune disease, leukemia, lymphoma, skin diseases, or open wounds) No clinical or laboratory evidence of an underlying immunosuppressive disorder No active or chronic infections No significant allergy or hypersensitivity to eggs Other: No active seizure disorders No other malignancy within the past 2 years except stage I cervical cancer or basal cell skin cancer, provided the tumor has been successfully treated and patient is currently disease free No evidence of bone marrow toxicity No other concurrent medical illness that would preclude study No other contraindications to vaccinia virus administration No encephalitis Must be able to avoid close contact with children under 3 years of age; pregnant women; individuals with prior or active eczema or other open skin conditions; or immunosuppressed individuals for 7-10 days after each vaccination Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Prior vaccinia immunization required (e.g., smallpox vaccination) More than 8 weeks since prior immunotherapy and recovered No prior therapy with live vaccinia virus vector Chemotherapy: More than 4 weeks since prior chemotherapy and recovered Endocrine therapy: At least 4 weeks since prior systemic corticosteroids No concurrent systemic corticosteroids No concurrent steroids Radiotherapy: See Disease Characteristics More than 2 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics More than 4 weeks since prior surgery for primary tumor or metastatic lesions and recovered Other: No concurrent immunosuppressive drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard L. Kaufman, MD
Organizational Affiliation
Herbert Irving Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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Vaccine Therapy in Treating Patients With Metastatic Melanoma

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