Vaccine Therapy With or Without Imiquimod in Treating Patients Who Have Undergone Surgery for Stage II, Stage III, or Stage IV Melanoma

NCT00118313 | Completed Phase 1 DMC

• 3 other identifiers: 11490UVACC-MEL-45UVACC-34204
• Study Type: interventional
• Target: N/A
• 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. Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Giving vaccine therapy together with imiquimod after surgery may help the body kill any remaining tumor cells. PURPOSE: This randomized phase I trial is studying the side effects and best way to give vaccine therapy with or without imiquimod in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.

Conditions

Melanoma (Skin)

Keywords

stage II melanoma; stage III melanoma; stage IV melanoma

Outcome Measures

Primary Outcomes (1)

• Safety if less than 33% of patients experience a dose-limiting at day 22

Secondary Outcomes (1)

• Immune response by Elispot assay at day 22

Interventions

incomplete Freund's adjuvant BIOLOGICAL

multi-epitope melanoma peptide vaccine BIOLOGICAL

sargramostim BIOLOGICAL

tetanus toxoid helper peptide BIOLOGICAL

dimethyl sulfoxide DRUG

imiquimod DRUG

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 12 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed melanoma * Stage II-IV disease * Has undergone surgical resection within the past 12 months * No clinical or radiological evidence of disease after surgical resection * Must have ≥ 1 undissected axillary and/or inguinal lymph node basin * HLA-A1, -A2, or -A3 positive * Ineligible for OR refused interferon PATIENT CHARACTERISTICS: Age * 12 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count \> 1,000/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin \> 9 g/dL Hepatic * AST and ALT ≤ 2.5 times upper limit of normal (ULN) * Bilirubin ≤ 2.5 times ULN * Lactic dehydrogenase ≤ 1.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN * Hepatitis C negative Renal * Creatinine ≤ 1.5 times ULN Cardiovascular * No New York Heart Association class III or IV heart disease Immunologic * HIV negative * No known or suspected allergy to any component of the study vaccines * No autoimmune disorder with visceral involvement * No prior active autoimmune disorder requiring cytotoxic or immunosuppressive therapy * The following immunologic conditions are allowed: * Laboratory evidence of autoimmune disease (e.g., positive anti-nuclear antibody titer) without symptoms * Clinical evidence of vitiligo * Other forms of depigmenting illness * Mild arthritis requiring non-steroidal anti-inflammatory drugs Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Weight ≥ 110 lbs * No uncontrolled diabetes * Hemoglobin A1C \< 7% (for patients with diabetes) * No medical contraindication or potential problem that would preclude study compliance * No known active addiction to alcohol or drugs * No recent (within the past year) or ongoing illicit IV drug use PRIOR CONCURRENT THERAPY: Biologic therapy * Prior vaccinations that resulted in recurrent disease during or after vaccine administration allowed provided the last vaccination was administered more than 12 weeks ago * Prior multi-epitope melanoma peptide vaccine that resulted in a negative immune response allowed * More than 4 weeks since prior and no concurrent interferon (e.g., Intron-A®), interleukins (e.g., Proleukin®), or growth factors (e.g., Procrit®, Aranesp®, or Neulasta®) * More than 4 weeks since prior and no concurrent allergy desensitization injections * No influenza vaccine for at least 2 weeks before or after study vaccine administration Chemotherapy * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas \[e.g., carmustine or lomustine\]) * No concurrent chemotherapy, including nitrosoureas Endocrine therapy * More than 4 weeks since prior and no concurrent oral or parenteral corticosteroids (e.g., prednisone) * No prior or concurrent inhaled steroids (e.g., Advair®, Flovent®, Azmacort®) * Concurrent topical corticosteroids allowed Radiotherapy * More than 4 weeks since prior and no concurrent radiotherapy * Prior stereotactic radiosurgery allowed provided it was completed within the past 12 months Surgery * See Disease Characteristics * More than 4 weeks since prior surgical resection of metastatic lesion(s) * No concurrent surgery requiring general anesthesia Other * More than 4 weeks since prior and no other concurrent investigational agents * More than 30 days since prior and no concurrent participation in another clinical study * No other concurrent immunosuppressive therapy

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

Sponsors & Collaborators

• Craig L Slingluff, Jr: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

incomplete Freund's adjuvant; sargramostim; Dimethyl Sulfoxide; Imiquimod; Chemotherapy, Adjuvant

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)

Sulfoxides; Sulfur Compounds; Organic Chemicals; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Craig L. Slingluff, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Surgery

Study Record Dates

• First Submitted: July 8, 2005
• First Posted: July 11, 2005
• Study Start: November 4, 2004
• Primary Completion: July 28, 2006
• Study Completion: July 28, 2006
• Last Updated: March 27, 2020

Record last verified: 2020-03

Locations

US (1)