Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma

NCT00003646 | Completed Phase 2 DMC

• 2 other identifiers: CDR0000066735VCL-1005-205
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Stage IV Melanoma; Stage III Melanoma; Recurrent Melanoma

Keywords

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

Interventions

allovectin-7 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vical: lead

Study Sites (3)

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Physician Reliance Network, Inc.

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Melanoma; Neoplasms; Skin Neoplasms

Interventions

Allovectin-7

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jennifer Fernandez

  Vical

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 3, 2004
• Study Start: August 1, 1998
• Primary Completion: March 1, 2002
• Study Completion: May 1, 2002
• Last Updated: July 7, 2011

Record last verified: 2011-07

Locations

US (3)