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A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma

Primary Purpose

Metastatic Melanoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Allovectin-7®
Dacarbazine (DTIC)
Temozolomide (TMZ)
Sponsored by
Vical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Melanoma focused on measuring Melanoma, DTIC, TMZ, Stage 3, Stage 4, Metastatic, Metastatic Melanoma (Stage 3, Stage 4 Melanoma)

Eligibility Criteria

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

Inclusion Criteria (Potential study participants must meet the following criteria):

  • Confirmed Stage 3 or Stage 4 melanoma that may have had previous treatment via surgery, radiation or biologic drugs (typically Interferon Alpha or Interleukin-2)
  • At least 1 melanoma tumor that is 1cm x 1cm or greater in size (about the size of a dime) and can be injected
  • Normal blood chemistries and blood cell counts
  • At least 18 years old and able and willing to provide informed consent to participate

Exclusion Criteria (Potential study participants will not be eligible with the following):

  • Previous chemotherapy treatment for melanoma
  • Melanoma lesions in the brain or liver (however, lesions in the lungs are allowed)
  • If surgical removal of all lesions would be possible and could be curative
  • Any melanoma tumors greater than 10cm x 10cm in size
  • Known condition resulting in a suppressed immune system
  • Female subjects who are pregnant

Sites / Locations

  • Location #40
  • Location #9
  • Location #1
  • Location #24
  • Location #36
  • Location #47
  • Location #16
  • Location #11
  • Location #7
  • Location #33
  • Location #20
  • Location #35
  • Location #4
  • Location #19
  • Location #38
  • Location #8
  • Location #87
  • Location #41
  • Location #23
  • Location #34
  • Location #12
  • Location #97
  • Location #28
  • Location #117
  • Location #27
  • Location #26
  • Location #32
  • Location #55
  • Location #63
  • Location #102
  • Location #99
  • Location #101
  • Location #104
  • Location #100
  • Location #103
  • Location #105
  • Location #106
  • Location #37
  • Location #88
  • Location # 75
  • Location #110
  • Location #112
  • Location #113
  • Location #114
  • Location #109
  • Location #74
  • Location #66
  • Location #115
  • Location #116
  • Location #90
  • Location #51
  • Location #91
  • Location #46
  • Location #89
  • Location #50
  • Location #48
  • Location #111
  • Location #44
  • Location #52
  • Location #45
  • Location #86
  • Location #84
  • Location #85
  • Location #82
  • Location #78
  • Location #79
  • Location #80
  • Location #81
  • Location #59
  • Location #60
  • Location #72
  • Location #65
  • Location #93
  • Location #61
  • Location #58
  • Location #62
  • Location #94
  • Location #57
  • Location #95
  • Location #67
  • Location #54
  • Location #68
  • Location #118
  • Location #43
  • Location #122
  • Location #124
  • Location #121
  • Location #123

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Arm

Control Arm

Arm Description

Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week.

DTIC 1000 mg/m2 intravenous infusion over 60 minutes, repeated every 28 days, OR TMZ 150 to 200 mg/m2 orally once daily for five consecutive days, repeated every 28 days.

Outcomes

Primary Outcome Measures

To compare the overall response rate at ≥24 weeks after randomization in the Allovectin-7® arm versus the control (DTIC/TMZ) arm.

Secondary Outcome Measures

To investigate the safety/tolerability of Allovectin-7® in comparison to DTIC/TMZ.
To investigate the effect of Allovectin-7® in comparison to DTIC-TMZ on overall survival.

Full Information

First Posted
October 31, 2006
Last Updated
September 11, 2013
Sponsor
Vical
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1. Study Identification

Unique Protocol Identification Number
NCT00395070
Brief Title
A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma
Official Title
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Treatment With 2 mg Intralesional Allovectin-7® Compared to Dacarbazine (DTIC) or Temozolomide (TMZ) in Subjects With Recurrent Metastatic Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To compare the safety and efficacy of Allovectin-7® versus Dacarbazine (DTIC)or Temozolomide (TMZ) in subjects with recurrent stage 3 or stage 4 melanoma.
Detailed Description
Eligible patients will have a 66% chance of receiving Allovectin-7® alone (an investigational product designed to train your body's immune system to recognize and destroy tumor cells) vs. a 33% chance of receiving standard chemotherapy (either dacarbazine or temozolomide). The treatment course recommended for patients who receive Allovectin-7® is a minimum of 16 weeks. Each cycle will consist of weekly injections of Allovectin-7® alone for six weeks followed by two weeks of observation and assessments. For patients who receive the chemotherapy alone, their treatment course will follow standard dosing. During the trial all patients' tumors will be closely monitored. Patients whose melanoma does not clinically progress will be encouraged to continue on the treatment and be assessed for up to two years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma
Keywords
Melanoma, DTIC, TMZ, Stage 3, Stage 4, Metastatic, Metastatic Melanoma (Stage 3, Stage 4 Melanoma)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
390 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week.
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
DTIC 1000 mg/m2 intravenous infusion over 60 minutes, repeated every 28 days, OR TMZ 150 to 200 mg/m2 orally once daily for five consecutive days, repeated every 28 days.
Intervention Type
Biological
Intervention Name(s)
Allovectin-7®
Intervention Description
Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week.
Intervention Type
Drug
Intervention Name(s)
Dacarbazine (DTIC)
Intervention Description
1000 mg/m2 intravenous infusion over 60 minutes, repeated every 28 days, OR
Intervention Type
Drug
Intervention Name(s)
Temozolomide (TMZ)
Intervention Description
150 to 200 mg/m2 orally once daily for five consecutive days, repeated every 28 days.
Primary Outcome Measure Information:
Title
To compare the overall response rate at ≥24 weeks after randomization in the Allovectin-7® arm versus the control (DTIC/TMZ) arm.
Time Frame
After all 375 subjects are enrolled
Secondary Outcome Measure Information:
Title
To investigate the safety/tolerability of Allovectin-7® in comparison to DTIC/TMZ.
Time Frame
After all 375 subjects are enrolled
Title
To investigate the effect of Allovectin-7® in comparison to DTIC-TMZ on overall survival.
Time Frame
After all 375 subjects are enrolled

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (Potential study participants must meet the following criteria): Confirmed Stage 3 or Stage 4 melanoma that may have had previous treatment via surgery, radiation or biologic drugs (typically Interferon Alpha or Interleukin-2) At least 1 melanoma tumor that is 1cm x 1cm or greater in size (about the size of a dime) and can be injected Normal blood chemistries and blood cell counts At least 18 years old and able and willing to provide informed consent to participate Exclusion Criteria (Potential study participants will not be eligible with the following): Previous chemotherapy treatment for melanoma Melanoma lesions in the brain or liver (however, lesions in the lungs are allowed) If surgical removal of all lesions would be possible and could be curative Any melanoma tumors greater than 10cm x 10cm in size Known condition resulting in a suppressed immune system Female subjects who are pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Strause, PhD
Organizational Affiliation
Vical
Official's Role
Study Director
Facility Information:
Facility Name
Location #40
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Location #9
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Location #1
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Location #24
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Location #36
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Location #47
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
Location #16
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Location #11
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Location #7
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Location #33
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Location #20
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Location #35
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Location #4
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Location #19
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Location #38
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Location #8
City
Montclair
State/Province
New Jersey
ZIP/Postal Code
07042
Country
United States
Facility Name
Location #87
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Location #41
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Location #23
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Location #34
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Location #12
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Location #97
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Location #28
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Location #117
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Location #27
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84103
Country
United States
Facility Name
Location #26
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Location #32
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Location #55
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Location #63
City
Liege
ZIP/Postal Code
B 4000
Country
Belgium
Facility Name
Location #102
City
Itaquera
State/Province
Sao Paulo
ZIP/Postal Code
08270-070
Country
Brazil
Facility Name
Location #99
City
Belo Horizonte
ZIP/Postal Code
30-380-490
Country
Brazil
Facility Name
Location #101
City
Curitiba
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
Location #104
City
Ijui
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Location #100
City
Lajeado
ZIP/Postal Code
95900-000
Country
Brazil
Facility Name
Location #103
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Location #105
City
Rio de Janeiro
ZIP/Postal Code
20230-0130
Country
Brazil
Facility Name
Location #106
City
Sao Paulo
Country
Brazil
Facility Name
Location #37
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Location #88
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Location # 75
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Location #110
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Location #112
City
Lyon
ZIP/Postal Code
69495
Country
France
Facility Name
Location #113
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Location #114
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Location #109
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Location #74
City
Paris Cedex 10
Country
France
Facility Name
Location #66
City
Paris Cedex 18
Country
France
Facility Name
Location #115
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Location #116
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Location #90
City
Augsburg
Country
Germany
Facility Name
Location #51
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Location #91
City
Dresden
Country
Germany
Facility Name
Location #46
City
Hannover
ZIP/Postal Code
30449
Country
Germany
Facility Name
Location #89
City
Jena
Country
Germany
Facility Name
Location #50
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Location #48
City
Lubeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Location #111
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Location #44
City
Munster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Location #52
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Location #45
City
Wurzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Location #86
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Location #84
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Location #85
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Location #82
City
Genoa
Country
Italy
Facility Name
Location #78
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
Location #79
City
Napoli
Country
Italy
Facility Name
Location #80
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Location #81
City
Siena
Country
Italy
Facility Name
Location #59
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Location #60
City
Leiden
ZIP/Postal Code
2333
Country
Netherlands
Facility Name
Location #72
City
Lubin
ZIP/Postal Code
59-301
Country
Poland
Facility Name
Location #65
City
Poznan
ZIP/Postal Code
61-866
Country
Poland
Facility Name
Location #93
City
Barnaul
ZIP/Postal Code
656049
Country
Russian Federation
Facility Name
Location #61
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Location #58
City
Moscow
ZIP/Postal Code
143900
Country
Russian Federation
Facility Name
Location #62
City
Nizniy Novogrod
ZIP/Postal Code
603000
Country
Russian Federation
Facility Name
Location #94
City
Samara
ZIP/Postal Code
443066
Country
Russian Federation
Facility Name
Location #57
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Location #95
City
Stavropol
Country
Russian Federation
Facility Name
Location #67
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Location #54
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Location #68
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Location #118
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Location #43
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Location #122
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Facility Name
Location #124
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Facility Name
Location #121
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Location #123
City
Kocaeli
ZIP/Postal Code
41400
Country
Turkey

12. IPD Sharing Statement

Links:
URL
http://www.vical.com
Description
Related Info

Learn more about this trial

A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma

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