Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00019721

Purpose

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may be an effective treatment for metastatic melanoma.

PURPOSE: Phase II trial to compare the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have metastatic melanoma that has not responded to previous therapy.

Condition	Intervention	Phase
Melanoma (Skin)	Biological: MART-1 antigen Biological: aldesleukin Biological: gp100 antigen Biological: incomplete Freund's adjuvant	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Immunization of Patients With Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Aldesleukin Freund's adjuvant

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

April 1999

Detailed Description:

OBJECTIVES:

Compare the efficacy of gp100:209-217(210M) peptide and MART-1:26-35(27L) peptide administered with or without high-dose interleukin-2 (IL-2) in patients with metastatic melanoma who are HLA-A0201 positive.
Determine the efficacy of these peptides in patients who cannot receive IL-2.
Compare the efficacy of IL-2 with or without these peptides in patients who need immediate treatment with IL-2.
Determine the efficacy of MART-1:26-35(27L) peptide in patients who have received prior gp100 antigen.
Compare the immunologic response experienced by patients who have received peptide, with or without IL-2, as measured by changes in T-cell precursors from before to after treatment.
Compare the toxic effects of these regimens in these patients.

OUTLINE: This is a partially randomized study.

Patients are assigned to 1 of 4 treatment groups based on disease status and prior therapy.

Group A (eligible to receive interleukin-2 (IL-2) but not in immediate need; no prior immunization with gp100 or MART-1 antigen): Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gp100 and MART-1 peptides emulsified in Montanide ISA-51 (ISA-51) subcutaneously (SC) on day 1. (Arm I closed as of 10/30/02).
- Arm II: Patients receive both peptides as in arm I on day 1 and high-dose IL-2 IV over 15 minutes every 8 hours on days 2-5 (for up to 12 doses). (Arm II closed as of 10/30/02).
Group B (ineligible to receive IL-2 due to other debilitating disease): Patients receive treatment as in group A, arm I.
Group C (need immediate IL-2 therapy due to extensive and rapid progression of disease): Patients receive treatment as in group A, arm II. (Group C closed as of 10/30/02).
Group D (prior immunization with gp100 antigen): Patients receive modified MART-1:26-35(27L) peptide emulsified in ISA-51 SC on day 1.

Treatment in all groups repeats every 3 weeks for 4 courses. Patients who achieve a minor, mixed, or partial response may receive up to 12 additional courses. Patients who achieve complete response receive 2 additional courses.

Patients are followed at 4-6 weeks.

PROJECTED ACCRUAL: A total of 103 patients (15-25 for group A, arm I; 19-33 for group A, arm II; and 15 each for groups B, C, and D) will be accrued for this study within 1 year.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed metastatic melanoma that has failed standard therapy
Measurable disease
HLA-A0201 positive

PATIENT CHARACTERISTICS:

Age:

16 and over

Performance status:

ECOG 0-2

Life expectancy:

More than 3 months

Hematopoietic:

WBC at least 3,000/mm^3
Platelet count at least 90,000/mm^3

Hepatic:

Bilirubin no greater than 2.0 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome)
AST/ALT less than 3 times normal
Hepatitis B surface antigen negative
No coagulation disorder

Renal:

Creatinine no greater than 2.0 mg/dL

Cardiovascular:

No major cardiovascular disease
If cardiovascular disease or other debilitating symptoms present, may receive peptide emulsified with Montanide ISA-51 only

Pulmonary:

No major respiratory disease

Other:

Not pregnant
Fertile patients must use effective contraception
HIV negative
No active systemic infection
No autoimmune disease or immunodeficiency disease
No primary or secondary immunodeficiency

PRIOR CONCURRENT THERAPY:

Biologic therapy:

At least 3 weeks since prior biologic therapy
No prior MART-1 antigen immunization

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00019721

Locations

United States, Maryland
Surgery Branch
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Steven A. Rosenberg, MD, PhD

NCI - Surgery Branch

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000067051, NCI-99-C-0092, NCI-T99-0033
Study First Received:	July 11, 2001
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00019721 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-HIV Agents
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Adjuvants, Immunologic
Antiviral Agents
Pharmacologic Actions

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Aldesleukin
Anti-Retroviral Agents
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Nevi and Melanomas
Freund's Adjuvant

ClinicalTrials.gov processed this record on November 09, 2009