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

Sponsored by:	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)	Drug: MART-1 antigen Drug: aldesleukin Drug: gp100 antigen Drug: incomplete Freund's adjuvant	Phase II

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Aldesleukin Interleukin-2 Freund's adjuvant Montanide ISA 51

U.S. FDA Resources

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

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

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

Study ID Numbers:

CDR0000067051, NCI-99-C-0092, NCI-T99-0033

First Received:

July 11, 2001

Last Updated:

December 13, 2008

ClinicalTrials.gov Identifier:

NCT00019721

Health Authority:

United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IV melanoma
recurrent melanoma

Study placed in the following topic categories:

Neuroectodermal Tumors
Aldesleukin
Interleukin-2
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Freund's Adjuvant
Nevus
Recurrence
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

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

Adjuvants, Immunologic
Antiviral Agents
Pharmacologic Actions
Neoplasms
Anti-Retroviral Agents
Therapeutic Uses
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 09, 2009