Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00019214|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 20, 2013
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
RATIONALE: Vaccines made from white blood cells treated with antigens may make the body build an immune response to kill melanoma cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may kill more melanoma cells.
PURPOSE: This phase I/II trial is studying the side effects and how well giving vaccine therapy and interleukin-2 works compared to vaccine therapy alone in treating patients with metastatic melanoma that has not responded to previous therapy.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: MART-1 antigen Biological: aldesleukin Biological: gp100 antigen||Phase 1 Phase 2|
- Evaluate the toxicity, immunologic reactivity, and possible therapeutic efficacy of immunization with dendritic cells presenting the MART-1 and gp100 melanoma antigens with or without interleukin-2 in patients with metastatic melanoma.
OUTLINE: This is a dose-escalation study of dendritic cells pulsed with MART-1 and gp100 antigens.
Patients receive vaccinations with dendritic cells pulsed with MART-1 and gp100 antigens, either intralymphatically every 4 weeks for 2 doses, or IV every 3 weeks for 4 doses. Some patients also receive interleukin-2 subcutaneously or IV, over 3-5 days, beginning 24 hours after immunization.
Cohorts of 2-9 patients receive escalating doses of pulsed dendritic cells IV until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Subsequent cohorts receive cells with or without interleukin-2. One cohort may expand to 15 patients to determine the accuracy of immunologic response to the vaccine.
One cohort of 11 patients receives cells intralymphatically without interleukin-2 every 3-4 weeks for 2 courses. Patients with stable disease or who achieve minor, mixed, or partial response may be retreated.
Patients with stable or responding disease undergo a second course of vaccination. Patients who completed treatment with vaccine alone and have stable disease, progressive disease, disease progression after a response, or a partial response with no further improvement may receive 2 additional courses.
PROJECTED ACCRUAL: A total of 10-42 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I/II Study in Patients With Metastatic Melanoma of Immunization With Dendritic Cells Presenting Epitopes Derived From The Melanoma Associated Antigens MART-1 and gp 100|
|Study Start Date :||April 1997|
|Actual Study Completion Date :||July 2006|
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Histologically confirmed metastatic melanoma that has failed standard effective therapy
- Measurable or evaluable disease
- HLA-A2 positive
- 18 and over
- ECOG 0-2
- More than 3 months
- WBC greater than 3,000/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 8.0 g/dL
- Bilirubin no greater than 2.0 mg/dL
- AST/ALT less than 4 times upper limit of normal
- Negative hepatitis B surface antigen
- No coagulation disorder
- Creatinine no greater than 1.6 mg/dL OR
- Creatinine clearance greater than 75 mL/min
- No major cardiovascular disease
- No major respiratory disease
- No major immunological disease
- No penicillin allergy
- HIV negative
- No active systemic infection
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- Not specified
- Not specified
- At least 4 weeks since prior steroid therapy and recovered
- Not specified
- Not specified
- More than 4 weeks since any other prior therapy and recovered
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): NCT00019214
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||James C. Yang, MD||NCI - Surgery Branch|
|Other Study ID Numbers:||
|First Posted:||January 27, 2003 Key Record Dates|
|Last Update Posted:||June 20, 2013|
|Last Verified:||January 2005|
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas