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Vaccine Therapy in Treating Patients With Unresectable Metastatic Melanoma

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
recombinant vaccinia-B7.1 vaccine
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically proven metastatic, unresectable melanoma Dermal, subcutaneous, or lymph node metastases Accessible for injection Lesions must measure at least 1 cm Patients with no prior treatment allowed Patients must have one of the following as proof of prior vaccinia immunization: Physician certification Recollection and appropriate vaccination scar site No encephalitis, untreated cerebral metastases, other structural brain lesions, or leptomeningeal disease No ascites or pleural effusions No leukemia or lymphoma PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Karnofsky 80-100% Life expectancy: Greater than 3 months WBC greater than 4,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 10g/dL Bilirubin less than 1.5 mg/dL Transaminases no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN PT/PTT no greater than 2 fold elevation in patients not receiving anticoagulation medications No alcoholic cirrhosis Creatinine less than 2.0 mg/dL OR creatine clearance greater than 60 mL/min No congestive heart failure No serious cardiac arrhythmias No recent prior myocardial infarction No clinical coronary artery disease No chronic obstructive pulmonary disease Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No seizure disorders No underlying immunosuppressive disorder No autoimmune disease HIV negative No skin diseases No open wounds No eczema or other contraindications to vaccinia virus administration Patients must be able to avoid high risk individuals (e.g., immunosuppressed patients, children under 3 years, pregnant women, patients with active or a history of eczema, or patients with other skin conditions) for 7-10 days following treatment No significant allergy or hypersensitivity to eggs No active or chronic infections No concurrent medical illness No other significant medical disease which would increase risk to patient No other prior malignancy within the past 5 years except stage I carcinoma of the cervix or basal cell carcinoma PRIOR CONCURRENT THERAPY: At least 8 weeks since prior immunotherapy and recovered No prior live pox virus vector No more than 2 prior chemotherapy regimens At least 4 weeks since prior chemotherapy and recovered At least 4 weeks since prior systemic corticosteroids No systemic corticosteroids for concurrent illness No concurrent immunosuppressive steroids At least 2 weeks since prior radiotherapy and recovered (no bone marrow toxicity) At least 6 months since prior radiotherapy for brain metastases and recovered At least 4 weeks since prior surgery for management of the primary or metastatic lesions and recovered with remaining measurable disease At least 6 months since prior surgery for brain metastases and recovered No concurrent immunosuppressive drugs

Sites / Locations

  • Albert Einstein Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

Patients receive rV-B7.1 intralesionally every 4 weeks for 8 weeks (weeks 0, 4, and 8). Treatment continues every 12 weeks in the absence of unacceptable toxicity or disease progression for up to 2 courses. Cohorts of 6-8 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 3 of 8 patients experience dose limiting toxicities.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 10, 1999
Last Updated
February 8, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004148
Brief Title
Vaccine Therapy in Treating Patients With Unresectable Metastatic Melanoma
Official Title
A Phase I Trial of Intra Lesional RV-B7.1 Vaccine in the Treatment of Malignant Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
Phase I trial to study the effectiveness of vaccine therapy in treating patients who have unresectable metastatic melanoma. Vaccines may make the body build an immune response to kill tumor cells.
Detailed Description
OBJECTIVES: I. Determine the maximum tolerated dose of the rV-B7.1 vaccine that elicits a host immune response and is associated with acceptable toxicity in patients with malignant metastatic melanoma. II. Determine all clinical toxicities associated with this regimen in this patient population. III. Determine the safety of this regimen in this patient population. IV. Assess evidence of host antimelanoma immune reactivity following this regimen. V. Determine the effect of this regimen on T-cell immunity. VI. Assess the clinical response in this patient population receiving this regimen. VII. Evaluate quality of life of these patients during this regimen. OUTLINE: This is a dose escalation study. Patients receive rV-B7.1 intralesionally every 4 weeks for 8 weeks (weeks 0, 4, and 8). Treatment continues every 12 weeks in the absence of unacceptable toxicity or disease progression for up to 2 courses. Cohorts of 6-8 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 3 of 8 patients experience dose limiting toxicities. Quality of life is assessed before treatment, every 4 weeks, and at end of treatment. Patients are followed every 3 months.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive rV-B7.1 intralesionally every 4 weeks for 8 weeks (weeks 0, 4, and 8). Treatment continues every 12 weeks in the absence of unacceptable toxicity or disease progression for up to 2 courses. Cohorts of 6-8 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 3 of 8 patients experience dose limiting toxicities.
Intervention Type
Biological
Intervention Name(s)
recombinant vaccinia-B7.1 vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven metastatic, unresectable melanoma Dermal, subcutaneous, or lymph node metastases Accessible for injection Lesions must measure at least 1 cm Patients with no prior treatment allowed Patients must have one of the following as proof of prior vaccinia immunization: Physician certification Recollection and appropriate vaccination scar site No encephalitis, untreated cerebral metastases, other structural brain lesions, or leptomeningeal disease No ascites or pleural effusions No leukemia or lymphoma PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Karnofsky 80-100% Life expectancy: Greater than 3 months WBC greater than 4,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 10g/dL Bilirubin less than 1.5 mg/dL Transaminases no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN PT/PTT no greater than 2 fold elevation in patients not receiving anticoagulation medications No alcoholic cirrhosis Creatinine less than 2.0 mg/dL OR creatine clearance greater than 60 mL/min No congestive heart failure No serious cardiac arrhythmias No recent prior myocardial infarction No clinical coronary artery disease No chronic obstructive pulmonary disease Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No seizure disorders No underlying immunosuppressive disorder No autoimmune disease HIV negative No skin diseases No open wounds No eczema or other contraindications to vaccinia virus administration Patients must be able to avoid high risk individuals (e.g., immunosuppressed patients, children under 3 years, pregnant women, patients with active or a history of eczema, or patients with other skin conditions) for 7-10 days following treatment No significant allergy or hypersensitivity to eggs No active or chronic infections No concurrent medical illness No other significant medical disease which would increase risk to patient No other prior malignancy within the past 5 years except stage I carcinoma of the cervix or basal cell carcinoma PRIOR CONCURRENT THERAPY: At least 8 weeks since prior immunotherapy and recovered No prior live pox virus vector No more than 2 prior chemotherapy regimens At least 4 weeks since prior chemotherapy and recovered At least 4 weeks since prior systemic corticosteroids No systemic corticosteroids for concurrent illness No concurrent immunosuppressive steroids At least 2 weeks since prior radiotherapy and recovered (no bone marrow toxicity) At least 6 months since prior radiotherapy for brain metastases and recovered At least 4 weeks since prior surgery for management of the primary or metastatic lesions and recovered with remaining measurable disease At least 6 months since prior surgery for brain metastases and recovered No concurrent immunosuppressive drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard L. Kaufman, MD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Albert Einstein Comprehensive Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15937544
Citation
Kaufman HL, Deraffele G, Mitcham J, Moroziewicz D, Cohen SM, Hurst-Wicker KS, Cheung K, Lee DS, Divito J, Voulo M, Donovan J, Dolan K, Manson K, Panicali D, Wang E, Horig H, Marincola FM. Targeting the local tumor microenvironment with vaccinia virus expressing B7.1 for the treatment of melanoma. J Clin Invest. 2005 Jul;115(7):1903-12. doi: 10.1172/JCI24624. Epub 2005 Jun 2.
Results Reference
result
PubMed Identifier
10811235
Citation
Kaufman HL, Conkright W, Divito J Jr, Horig H, Kaleya R, Lee D, Mani S, Panicali D, Rajdev L, Ravikumar TS, Wise-Campbell S, Surhland MJ. A phase I trial of intra lesional RV-B7.1 vaccine in the treatment of malignant melanoma. Hum Gene Ther. 2000 May 1;11(7):1065-82. doi: 10.1089/10430340050015374. No abstract available.
Results Reference
result

Learn more about this trial

Vaccine Therapy in Treating Patients With Unresectable Metastatic Melanoma

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