Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma
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ClinicalTrials.gov Identifier: NCT00003646 |
Recruitment Status :
Completed
First Posted : May 3, 2004
Last Update Posted : July 7, 2011
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Stage IV Melanoma Stage III Melanoma Recurrent Melanoma | Drug: allovectin-7 | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 78 participants |
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 |
Study Start Date : | August 1998 |
Actual Primary Completion Date : | March 2002 |
Actual Study Completion Date : | May 2002 |


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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003646
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 |
Study Chair: | Jennifer Fernandez | Vical |
Responsible Party: | Dmitri D. Kharkevitch, MD, PhD, Vical Incorporated |
ClinicalTrials.gov Identifier: | NCT00003646 |
Obsolete Identifiers: | NCT00416806 |
Other Study ID Numbers: |
CDR0000066735 VCL-1005-205 ( Other Identifier: Vical ) |
First Posted: | May 3, 2004 Key Record Dates |
Last Update Posted: | July 7, 2011 |
Last Verified: | July 2011 |
adult solid tumor body system/site cancer cancer melanoma recurrent melanoma |
skin tumor solid tumor stage III melanoma stage IV melanoma stage, melanoma |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |