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

• Status: Completed
• Trial end date: 2010-02-01
• 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. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cyclophosphamide may also stimulate the immune system in different ways and stop tumor cells from growing. Giving vaccine therapy together with cyclophosphamide after surgery may cause a stronger immune response to kill any remaining tumor cells. It may also prevent or delay the recurrence of melanoma.

PURPOSE: This randomized phase I/II trial is studying the side effects of vaccine therapy when given with or without cyclophosphamide and to see how well they work in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Craig L Slingluff, Jr; University of Virginia
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Freund's Adjuvant; Vaccines

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed melanoma

• Cutaneous, mucosal, or primary melanoma

• Stage IIB-IV disease

• Has undergone surgical resection or stereotactic radiosurgery for malignant melanoma ≥ 1 week but ≤ 6 months ago

• No clinical or radiological evidence of disease after surgical resection or stereotactic radiosurgery by chest x-ray or CT scan*, abdominal and pelvic CT scan*, and head CT scan or MRI NOTE: *Positron emission tomography scan/CT fusion scan may replace scans of the chest, abdomen, and pelvis

• Must have ≥ 2 intact (undissected) axillary and/or inguinal lymph node basins

• HLA-A1, -A2, or -A3 positive AND HLA-DR1, -DR4, -DR11, -DR13, or -DR15 positive

• Ineligible for OR refused interferon

• No ocular melanoma

• Brain metastases allowed provided all of the following criteria are met:

• No more than 3 total brain metastases

• Each metastasis ≤ 2 cm in diameter at the time of study entry

• Each metastasis was completely removed by surgery or treated with stereotactic radiosurgery

• No evidence of brain metastasis progression since the most recent treatment

PATIENT CHARACTERISTICS:

Age

• 18 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 or 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%

• No medical contraindication or potential problem that would preclude study compliance

• No other malignancy except squamous cell or basal cell skin cancer without known metastasis, carcinoma in situ of the breast (ductal or lobular) or cervix, or other successfully treated cancer without distant metastasis with no evidence of recurrence or metastasis for > 5 years

• 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

• No prior vaccination with any of the synthetic peptides used in this study

• Prior vaccinations (containing agents other than the synthetic peptides used in this study) that resulted in recurrent disease during or after vaccine administration allowed provided the last vaccination was administered more than 12 weeks ago

• 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 vaccines for at least 2 weeks before or after study vaccine administration

Chemotherapy

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

• No concurrent chemotherapy, including nitrosoureas

Endocrine therapy

• More than 4 weeks since prior and no concurrent oral or parenteral corticosteroids

• No prior or concurrent inhaled steroids (e.g., Advair®, Flovent®, or Azmacort®)

• Prior or concurrent topical corticosteroids allowed

Radiotherapy

• See Disease Characteristics

• More than 4 weeks since other prior and no concurrent radiotherapy

Surgery

• See Disease Characteristics

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