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| Sponsored by: |
National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00019448 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Stage IV Melanoma Recurrent Melanoma |
Drug: gp100 antigen Drug: interleukin-2 |
Phase II |
| Study Type: | Interventional |
| Study Design: | 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 |
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
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
Contacts and Locations More Information
| Study ID Numbers: | CDR0000066215, NCI-98-C-0086 |
| Study First Received: | March 1, 2007 |
| Last Updated: | March 1, 2007 |
| ClinicalTrials.gov Identifier: | NCT00019448 History of Changes |
| Health Authority: | United States: Federal Government |
|
adult solid tumor body system/site cancer cancer melanoma recurrent melanoma |
skin tumor solid tumor stage IV melanoma stage, melanoma |
|
Skin Neoplasms Recurrence Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Interleukin-2 Analgesics, Non-Narcotic |
Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Nevus Analgesics Peripheral Nervous System Agents |
|
Disease Attributes Neoplasms by Histologic Type Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Pharmacologic Actions Recurrence Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms |
Pathologic Processes Sensory System Agents Analgesics, Non-Narcotic Interleukin-2 Therapeutic Uses Neoplasms, Germ Cell and Embryonal Nevi and Melanomas Peripheral Nervous System Agents Analgesics Central Nervous System Agents |
