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

Sponsor

Vical (Industry)

Overall Status

Completed

CT.gov ID

NCT00395070

Collaborator

(none)

390

Enrollment

Locations

Arms

Duration (Months)

4.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Melanoma	Biological: Allovectin-7® Drug: Dacarbazine (DTIC) Drug: Temozolomide (TMZ)	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

390 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Arm Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week.	Biological: Allovectin-7® Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week.
Active Comparator: Control Arm 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.	Drug: Dacarbazine (DTIC) 1000 mg/m2 intravenous infusion over 60 minutes, repeated every 28 days, OR Drug: Temozolomide (TMZ) 150 to 200 mg/m2 orally once daily for five consecutive days, repeated every 28 days.

Arm

Intervention/Treatment

Experimental: Treatment Arm

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

Biological: Allovectin-7®

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

Active Comparator: Control Arm

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.

Drug: Dacarbazine (DTIC)

1000 mg/m2 intravenous infusion over 60 minutes, repeated every 28 days, OR

Drug: Temozolomide (TMZ)

150 to 200 mg/m2 orally once daily for five consecutive days, repeated every 28 days.

Outcome Measures

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. [After all 375 subjects are enrolled]

Secondary Outcome Measures

To investigate the safety/tolerability of Allovectin-7® in comparison to DTIC/TMZ. [After all 375 subjects are enrolled]
To investigate the effect of Allovectin-7® in comparison to DTIC-TMZ on overall survival. [After all 375 subjects are enrolled]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Location #40	Tucson	Arizona	United States	85724
2	Location #9	Little Rock	Arkansas	United States	72205
3	Location #1	Bakersfield	California	United States	93309
4	Location #24	San Diego	California	United States	92093
5	Location #36	San Diego	California	United States	92161
6	Location #47	San Francisco	California	United States	94117
7	Location #16	Denver	Colorado	United States	80045
8	Location #11	Lakeland	Florida	United States	33805
9	Location #7	Chicago	Illinois	United States	60068
10	Location #33	Chicago	Illinois	United States	60612
11	Location #20	Louisville	Kentucky	United States	40202
12	Location #35	Baltimore	Maryland	United States	21202
13	Location #4	Kansas City	Missouri	United States	64111
14	Location #19	St. Louis	Missouri	United States	63110
15	Location #38	Hackensack	New Jersey	United States	07601
16	Location #8	Montclair	New Jersey	United States	07042
17	Location #87	Albuquerque	New Mexico	United States	87131
18	Location #41	Cincinnati	Ohio	United States	45219
19	Location #23	Cleveland	Ohio	United States	44106
20	Location #34	Portland	Oregon	United States	97239
21	Location #12	Bethlehem	Pennsylvania	United States	18015
22	Location #97	Providence	Rhode Island	United States	02903
23	Location #28	Dallas	Texas	United States	75246
24	Location #117	Houston	Texas	United States	77030
25	Location #27	Salt Lake City	Utah	United States	84103
26	Location #26	Salt Lake City	Utah	United States	84112
27	Location #32	Seattle	Washington	United States	98104
28	Location #55	Brussels		Belgium	1200
29	Location #63	Liege		Belgium	B 4000
30	Location #102	Itaquera	Sao Paulo	Brazil	08270-070
31	Location #99	Belo Horizonte		Brazil	30-380-490
32	Location #101	Curitiba		Brazil	81520-060
33	Location #104	Ijui		Brazil	98700-000
34	Location #100	Lajeado		Brazil	95900-000
35	Location #103	Porto Alegre		Brazil	90610-000
36	Location #105	Rio de Janeiro		Brazil	20230-0130
37	Location #106	Sao Paulo		Brazil
38	Location #37	Calgary	Alberta	Canada	T2N 4N2
39	Location #88	Winnipeg	Manitoba	Canada	R3E 0V9
40	Location # 75	Ottawa	Ontario	Canada	K1H 8L6
41	Location #110	Bordeaux		France	33075
42	Location #112	Lyon		France	69495
43	Location #113	Marseille		France	13009
44	Location #114	Montpellier		France	34295
45	Location #109	Nantes		France	44093
46	Location #74	Paris Cedex 10		France
47	Location #66	Paris Cedex 18		France
48	Location #115	Toulouse		France	31059
49	Location #116	Villejuif		France	94800
50	Location #90	Augsburg		Germany
51	Location #51	Berlin		Germany	10117
52	Location #91	Dresden		Germany
53	Location #46	Hannover		Germany	30449
54	Location #89	Jena		Germany
55	Location #50	Kiel		Germany	24105
56	Location #48	Lubeck		Germany	23538
57	Location #111	Ludwigshafen		Germany	67063
58	Location #44	Munster		Germany	48149
59	Location #52	Tubingen		Germany	72076
60	Location #45	Wurzburg		Germany	97080
61	Location #86	Jerusalem		Israel	91120
62	Location #84	Petach Tikva		Israel	49100
63	Location #85	Tel Hashomer		Israel	52621
64	Location #82	Genoa		Italy
65	Location #78	Milan		Italy	20141
66	Location #79	Napoli		Italy
67	Location #80	Padova		Italy	35128
68	Location #81	Siena		Italy
69	Location #59	Groningen		Netherlands	9713 GZ
70	Location #60	Leiden		Netherlands	2333
71	Location #72	Lubin		Poland	59-301
72	Location #65	Poznan		Poland	61-866
73	Location #93	Barnaul		Russian Federation	656049
74	Location #61	Moscow		Russian Federation	115478
75	Location #58	Moscow		Russian Federation	143900
76	Location #62	Nizniy Novogrod		Russian Federation	603000
77	Location #94	Samara		Russian Federation	443066
78	Location #57	St. Petersburg		Russian Federation	197758
79	Location #95	Stavropol		Russian Federation
80	Location #67	Barcelona		Spain	08036
81	Location #54	Valencia		Spain	46014
82	Location #68	Zaragoza		Spain	50009
83	Location #118	Bern		Switzerland	CH-3010
84	Location #43	Zurich		Switzerland	8091
85	Location #122	Ankara		Turkey	06590
86	Location #124	Antalya		Turkey	07070
87	Location #121	Izmir		Turkey	35100
88	Location #123	Kocaeli		Turkey	41400