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.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.
Brief Title
Vaccine Therapy in Treating Patients With 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.
* 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.
Categories
Conditions
Melanoma (Skin)
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
stage IV melanoma
recurrent melanoma
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT00022568
Org Class
Nih
Org Full Name
National Cancer Institute (NCI)
Org Study Id
CDR0000068831
Overall Status
Unknown status
Phases
Phase 1
Official Title
A Phase I Trial of Intra Lesional rV-Tricom Vaccine in the Treatment of Malignant Melanoma
Secondary Ids
Secondary Id
CPMC-IRB-14387
Secondary Id
AECM-01-003
Secondary Id
NCI-3353
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
CPDMU_PI Kaufman
Investigator Email
Investigator Phone