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

Sponsor:	Vical
Information provided by:	Vical
ClinicalTrials.gov Identifier:	NCT00395070

Purpose

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	Intervention	Phase
Metastatic Melanoma	Biological: Allovectin-7® Drug: Dacarbazine (DTIC) Drug: Temozolomide (TMZ)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Melanoma

Drug Information available for: Temozolomide Allovectin 7 Dacarbazine

U.S. FDA Resources

Further study details as provided by Vical:

Primary Outcome Measures:

Variant of Progression Free Survival: Durable Response Rate (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To investigate the safety/tolerability of Allovectin-7® in comparison to DTIC/TMZ. [ Time Frame: After all 375 subjects are enrolled ] [ Designated as safety issue: Yes ]
To investigate the effect of Allovectin-7® in comparison to DTIC-TMZ on overall survival. [ Time Frame: After all 375 subjects are enrolled ] [ Designated as safety issue: No ]

Estimated Enrollment:	375
Study Start Date:	October 2006
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment Arm	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	Drug: Dacarbazine (DTIC) 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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395070

Show 88 Study Locations

Sponsors and Collaborators

Vical

Investigators

Study Director:

Linda Strause, PHD

Vical

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Linda Strause, PHD, Executive Director, Clinical Oncology, Vical Incorporated
ClinicalTrials.gov Identifier:	NCT00395070 History of Changes
Other Study ID Numbers:	LX01-315
Study First Received:	October 31, 2006
Last Updated:	July 5, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vical:

Melanoma
DTIC
TMZ
Stage 3

Stage 4
Metastatic
Metastatic Melanoma (Stage 3, Stage 4 Melanoma)

Additional relevant MeSH terms:

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

Dacarbazine
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012