RATIONALE: Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Montanide ISA-51 may stimulate the immune system to kill tumor cells. Combining sargramostim with Montanide ISA-51 may cause a stronger immune response and kill more tumor cells.

PURPOSE: This randomized clinical trial is studying sargramostim to see how well it works compared to sargramostim and Montanide ISA-51 or Montanide ISA-51 alone in treating patients with stage I or stage II melanoma.

Condition	Treatment or Intervention
Recurrent Melanoma stage I melanoma stage II melanoma	Drug: Montanide ISA-51  Drug: sargramostim  Procedure: biological response modifier therapy  Procedure: colony-stimulating factor therapy  Procedure: cytokine therapy  Procedure: diagnostic test  Procedure: non-specific immune-modulator therapy  Procedure: sentinel node biopsy

Further Study Details: 

OBJECTIVES:

• Compare the effects, specifically on cells at and around the tumor site and in the lymph node that drains the tumor, of sargramostim (GM-CSF) alone vs Montanide ISA-51 alone vs GM-CSF and Montanide ISA-51 vs placebo in patients with stage I or II melanoma.

OUTLINE: This is a randomized, placebo-controlled, open-label study. Patients are randomized to 1 of 4 treatment arms.

• Arm I: Patients receive sargramostim (GM-CSF) at the excision site.
• Arm II: Patients receive Montanide ISA-51 at the excision site.
• Arm III: Patients receive GM-CSF and Montanide ISA-51 at the excision site.
• Arm IV: Patients receive placebo at the excision site. In all arms, after injection is complete, patients undergo surgery to remove the sentinel lymph node.

PROJECTED ACCRUAL: A maximum of 56 patients will be accrued for this study.

Ages Eligible for Study:  18 Years   -   85 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of melanoma
• Stage I or II disease
• No evidence of metastases
• No pleural effusions

PATIENT CHARACTERISTICS: Age

• 18 to 85

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Hematopoietic function normal

Hepatic

• Hepatic function normal

Renal

• Creatinine ≤ 1.5 times upper limit of normal

Cardiovascular

• No New York Heart Association class III or IV heart disease

Pulmonary

• No active pulmonary disease
• No history of pulmonary edema

Other

• No other cancer within the past 5 years except squamous cell or basal cell skin cancer without known metastases or carcinoma of the breast or cervix
• Not pregnant

PRIOR CONCURRENT THERAPY: Biologic therapy

• More than 12 weeks since prior interferon therapy
• More than 4 weeks since prior allergy shots
• More than 4 weeks since prior growth factors

Chemotherapy

• More than 12 weeks since prior chemotherapy

Endocrine therapy

• More than 4 weeks since prior steroids

Radiotherapy

• More than 12 weeks since prior radiotherapy

Surgery

• Not specified

Virginia
      Cancer Center at the University of Virginia, Charlottesville,  Virginia,  22908,  United States; Recruiting

Study chairs or principal investigators

Craig L. Slingluff, MD,  Study Chair,  University of Virginia, Health Sciences Center Cancer Center   

Study ID Numbers:  CDR0000378172; UVACC-MEL-38; UVACC-14499; UVACC-HIC-8380; NCT00089232
Record last reviewed:  September 2004
Last Updated:  February 24, 2005
Record first received:  August 4, 2004
ClinicalTrials.gov Identifier:  NCT00089232
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08