Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
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| ClinicalTrials.gov Identifier: NCT00019448 |
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Recruitment Status :
Completed
First Posted : March 5, 2007
Last Update Posted : June 20, 2013
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RATIONALE: Vaccines made from DNA may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Combining vaccine therapy and interleukin-2 may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy with or without interleukin-2 in treating patients with metastatic melanoma that has not responded to previous treatment.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stage IV Melanoma Recurrent Melanoma | Drug: gp100 antigen Drug: interleukin-2 | Phase 2 |
OBJECTIVES: I. Determine the clinical response of patients receiving DNA gp100 antigen alone or in combination with interleukin-2 for recurrent metastatic melanoma.
II. Identify the immunologic response in these patients prior to and after these treatments.
III. Determine the toxicity of these treatments in these patients.
PROTOCOL OUTLINE: Patients are accrued for the first three cohorts and the study proceeds to the final two cohorts if responses are observed.
Cohort I: Patients receive gp100 antigen intramuscularly (IM) into each of 2 proximal extremities once every 4 weeks for up to 4 doses. (Closed as of December, 1999) Cohort II: Patients receive gp100 antigen intradermally (ID) at 5 sites on each of 2 proximal extremities once every 4 weeks for up to 4 doses. (Closed as of December, 1999) Cohort III: Patients receive gp100 antigen IM into each of 2 proximal extremities once every 4 weeks for up to 4 doses. If patients do not exhibit immunologic response or dose-limiting toxicity, they may receive a higher dose of gp100 antigen on subsequent courses.
Cohort IV: If cohorts I, II, or III do not produce an immune response and do not experience dose-limiting toxicity, patients receive a higher dose of gp100 antigen IM into each of 2 proximal extremities every 4 weeks for up to 4 doses.
Cohort V: Patients receive gp100 antigen IM or ID at the dose found to produce immunization once every 4 weeks for up to 4 doses. Patients also receive interleukin-2 IV over 15 minutes every 8 hours for 5 days (15 doses), beginning within 24 hours after gp100 antigen.
Patients with minor, mixed, or partial response or stable disease may receive additional courses of treatment following 3-4 weeks of rest. Patients receive a maximum of 12 courses.
Patients are followed at 4-6 weeks.
PROJECTED ACCRUAL:
A maximum of 65 patients will be accrued for this study within 1 year.
| Study Type : | Interventional (Clinical Trial) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Study of DNA Encoding the gp100 Antigen Alone or in Combination With Interleukin-2 in Patients With Recurrent Metastatic Melanoma |
| Study Start Date : | September 1998 |
| Actual Study Completion Date : | March 2007 |
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Diagnosis of metastatic melanoma that has failed standard therapy Measurable disease --Prior/Concurrent Therapy-- Biologic therapy: At least 3 weeks since prior biologic therapy Chemotherapy: At least 3 weeks since prior chemotherapy Endocrine therapy: At least 3 weeks since prior endocrine therapy No concurrent steroid therapy Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Prior surgery allowed --Patient Characteristics-- Age: 16 and over Performance status: ECOG 0 or 1 Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 90,000/mm3 No coagulation disorder Hepatic: Bilirubin no greater than 1.6 mg/dL ALT/AST less than 2 times normal Hepatitis B surface antigen negative Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No major cardiovascular disease Pulmonary: No major respiratory disease Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No active systemic infections No autoimmune disease No primary or secondary immunodeficiency HIV negative
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): NCT00019448
| United States, Maryland | |
| Surgery Branch | |
| Bethesda, Maryland, United States, 20892 | |
| Study Chair: | Steven A. Rosenberg | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00019448 |
| Obsolete Identifiers: | NCT00001692 |
| Other Study ID Numbers: |
CDR0000066215 NCI-98-C-0086 |
| First Posted: | March 5, 2007 Key Record Dates |
| Last Update Posted: | June 20, 2013 |
| Last Verified: | September 2001 |
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adult solid tumor body system/site cancer cancer melanoma recurrent melanoma |
skin tumor solid tumor stage IV melanoma stage, melanoma |
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Melanoma Recurrence Disease Attributes Pathologic Processes Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Nerve Tissue Nevi and Melanomas Interleukin-2 Antineoplastic Agents Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |