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Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

Phase II Study of Allovectin-7 as an Immunotherapeutic Agent in Patients With Stages III and IV Melanoma

NCT00003646•Vical

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.

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

Age

18 - No limit years

Sex

All

Healthy Volunteers

Inclusion 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
+13 more criteria

Locations (3)

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Physician Reliance Network, Inc.

Dallas, Texas, United States

Key Dates

Start Date

August 1, 1998

Primary Completion Date

March 1, 2002

Completion Date

May 1, 2002

Last Updated

July 7, 2011

Enrollment

ACTUAL participants

Conditions

Stage IV MelanomaStage III MelanomaRecurrent Melanoma

Interventions

allovectin-7

DRUG

Dinaciclib in Treating Patients With Stage IV Melanoma

NCT00937937

Acral Lentiginous MelanomaCutaneous Nodular Melanoma+5 more

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ACTIVE_NOT_RECRUITINGPHASE1

Riluzole and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors or Melanoma

NCT01303341

Advanced Malignant Solid NeoplasmRecurrent Melanoma+6 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 7, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Dinaciclib in Treating Patients With Stage IV Melanoma

Riluzole and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors or Melanoma

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Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

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