Vaccine Therapy and GM-CSF With or Without Low-Dose Aldesleukin in Treating Patients With Stage II, Stage III, or Stage IV Melanoma

NCT00470015 | Completed Phase 1 DMC

• 5 other identifiers: CDR0000542631P30CA015083MC057506-002650NCI-2009-1306
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Aldesleukin may stimulate the white blood cells to kill tumor cells. Giving vaccine and different doses of GM-CSF mixed in incomplete Freund's adjuvant, with or without aldesleukin, may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and how well giving vaccine therapy together with GM-CSF, with or without low-dose aldesleukin, works in treating patients with stage II, stage III, or stage IV melanoma.

Conditions

Melanoma (Skin)

Keywords

stage II melanoma; stage III melanoma; stage IV melanoma; recurrent melanoma

Outcome Measures

Primary Outcomes (2)

• Percent changes in peptide vaccine-specific immune responses (tetramer frequencies) from pretreatment levels

  12 weeks

• Number and severity of hematologic and nonhematologic toxicities observed at each dose level

  12 weeks

Secondary Outcomes (4)

• Delayed-type hypersensitivity positivity

  12 weeks

• Maximum percent change in CD4, CD8, CD14, CD19, and C20 levels from preimmunization levels

  12 weeks

• Time to treatment failure

  12 weeks

• Time to progression

  24 months

Study Arms (1)

MART1 Analog, gp100 and Survivin

EXPERIMENTAL

Biological: MART-1 antigen; Biological: IL-2; Biological: gp100 antigen; Biological: GM-CSF; Biological: MART-1a peptide

Interventions

MART-1 antigen BIOLOGICAL

1000 mcg; Day 1 of a 21 day cycle x 4

MART1 Analog, gp100 and Survivin

IL-2 BIOLOGICAL

0.5x10\^6/m\^2

Also known as: Interleukin-2, Proleukin®, aldesleukin

MART1 Analog, gp100 and Survivin

gp100 antigen BIOLOGICAL

1000 mcg; Day 1 of a 21 day cycle x 4

MART1 Analog, gp100 and Survivin

GM-CSF BIOLOGICAL

300mcg

Also known as: Leukine-Liquid, sargramostatin

MART1 Analog, gp100 and Survivin

MART-1a peptide BIOLOGICAL

1000 mcg; Day 1 of a 21 day cycle x 4

MART1 Analog, gp100 and Survivin

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed melanoma * Stage II-IV disease * Completely resected disease * No known standard therapy that is potentially curative or proven capable of extending life expectancy exists * HLA-A2 positive PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 12 weeks * ANC ≥ 1,500/mm³ * Hemoglobin \> 10 g/dL * Platelet count ≥ 50,000/mm³ * AST ≤ 3 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 3 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled or current infection * No known allergy to vaccine or immunoadjuvant components * No known immune deficiency PRIOR CONCURRENT THERAPY: * No chemotherapy within the past 4 weeks and recovered * No biologic therapy within the past 4 weeks * No radiation therapy within the past 4 weeks

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

MART-1 Antigen; Interleukin-2; aldesleukin; Granulocyte-Macrophage Colony-Stimulating Factor; Colony-Stimulating Factors

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Melanoma-Specific Antigens; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens, Neoplasm; Antigens; Biological Factors; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Lymphokines; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors

Study Officials

• Svetomir Markovic, MD, PhD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 7, 2007
• Study Start: March 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: January 2, 2013
• Last Updated: February 19, 2019

Record last verified: 2019-02

Locations

US (1)