Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma - Full Text View

Purpose

RATIONALE: Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating patients who have stage III or stage IV melanoma that has not responded to previous treatment.

Condition	Intervention	Phase
Stage IV Melanoma Stage III Melanoma Recurrent Melanoma	Drug: allovectin-7	Phase 2


Study Type:	Interventional
Study Design:	Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Phase II Study of Allovectin-7 as an Immunotherapeutic Agent in Patients With Stages III and IV Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Melanoma

Genetic and Rare Diseases Information Center resources: Carcinoid Tumor Neuroepithelioma

U.S. FDA Resources

Further study details as provided by Vical:


Enrollment:	78
Study Start Date:	August 1998
Study Completion Date:	May 2002
Primary Completion Date:	March 2002 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES: I. Demonstrate an objective clinical response (partial or complete) with a median duration of at least 4 months in 15% of patients with stage III or IV melanoma treated with Allovectin-7. Allovectin-7 is a direct gene transfer immunotherapeutic agent.

II. Determine the benefits, risks, and side effects of Allovectin-7 in this patient population.

PROTOCOL OUTLINE: This is a multicenter study. Patients receive an intratumoral injection of Allovectin-7 once weekly for 6 weeks. At week 9, a complete disease status assessment is performed. Patients with stable or responding disease may receive additional courses of 6 injections.

PROJECTED ACCRUAL:

A total of 70 patients will be accrued for this study.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Histologically confirmed melanoma; Stage III with locoregional disease, in transit metastasis, or nodal disease OR Stage IV metastatic disease in skin, subcutaneous tissue, lymph node(s), and/or lung
At least 1 metastasis for which surgery is not deemed to be a curative option
Relapsed from or has not responded to frontline chemotherapy or biotherapy
At least 1 measurable tumor at least 1 cm by 1 cm, but less than 5 cm by 5 cm
No history of brain metastases or visceral metastases other than lung metastases

--Prior/Concurrent Therapy--

Biologic therapy: See Disease Characteristics; At least 4 weeks since prior biologic therapy
Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy
Endocrine therapy: No concurrent immunosuppressive drugs
Radiotherapy: At least 4 weeks since prior radiotherapy
Surgery: At least 2 weeks since prior major surgery
Other: No other concurrent anticancer drug therapy, or any other experimental therapy

--Patient Characteristics--

Age: 18 and over
Performance status: Karnofsky 80-100%
Life expectancy: At least 6 months
Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL
Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT/SGPT less than 3 times upper limit of normal; PT/PTT normal LDH and albumin normal
Renal: Creatinine no greater than 2.0 mg/dL
Cardiovascular: No uncontrolled hypertension; No New York Heart Association class III or IV disease
Other: HIV negative; Negative pregnancy test; Fertile patients must use effective contraception; No active autoimmune disease; No active infection requiring parenteral antibiotics; No uncontrolled diabetes mellitus; No other prior malignancy in the past 5 years except skin cancer or stage 0-II cervical cancer; No significant psychiatric disorders

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003646

Locations


United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
United States, Texas
Physician Reliance Network, Inc.
Dallas, Texas, United States, 75246

Sponsors and Collaborators

Vical

Investigators


Study Chair:	Jennifer Fernandez	Vical

More Information


Responsible Party:	Dmitri D. Kharkevitch, MD, PhD, Vical Incorporated
ClinicalTrials.gov Identifier:	NCT00003646 History of Changes
Obsolete Identifiers:	NCT00416806
Other Study ID Numbers:	CDR0000066735 VCL-1005-205 ( Other Identifier: Vical )
Study First Received:	November 1, 1999
Last Updated:	July 5, 2011

Keywords provided by Vical:


adult solid tumor body system/site cancer cancer melanoma recurrent melanoma	skin tumor solid tumor stage III melanoma stage IV melanoma stage, 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

ClinicalTrials.gov processed this record on August 17, 2017