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

• Status: Completed
• Trial end date: 2006-07-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Craig L Slingluff, Jr
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dimethyl Sulfoxide; Freund's Adjuvant; Imiquimod; Sargramostim; Vaccines

Criteria

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