Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Vaccine Therapy in Treating Patients With Stage IIIC or Stage IV Malignant Melanoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI MCC-13639 MCC-102781, NCT00101166

Objectives

Primary

1. Determine the specific anti-tumor immune response in patients with stage IIIC or IV malignant melanoma treated with vaccine therapy comprising autologous tumor cells and a sargramostim (GM-CSF)-producing and CD40L-expressing cell line (GM.CD40L).
2. Determine the toxicity of this regimen in these patients.

Secondary

1. Determine the tumor response rate, time to progression, disease-free survival, and overall survival of patients treated with this regimen.
2. Determine the specific anti-tumor immune response and anti-tumor immune response rate in HLA -A2-positive patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed malignant melanoma
  • Stage IIIC or IV disease



• Measurable disease



• No symptomatic brain metastasis

Prior/Concurrent Therapy:

Biologic therapy

• More than 4 weeks since prior immunotherapy
• No other concurrent immunotherapy

Chemotherapy

• More than 4 weeks since prior chemotherapy
• No concurrent chemotherapy

Endocrine therapy

• More than 4 weeks since prior steroids
• No concurrent steroids

Radiotherapy

• More than 2 weeks since prior radiotherapy
• No concurrent radiotherapy

Surgery

• Not specified

Other

• No concurrent immunosuppressive therapy

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC > 3,000/mm³
• Absolute neutrophil count > 1,500/mm³
• Platelet count > 100,000/mm³
• Hematocrit > 25%
• Hemoglobin > 8 g/dL

Hepatic

• Bilirubin < 2.0 mg/dL

Renal

• Creatinine < 2.0 mg/dL

  OR

• Creatinine clearance > 60 mL/min

Immunologic

• No serious ongoing infection
• No known HIV infection
• No other pre-existing immunodeficiency condition

Other

• No other active primary cancer
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception for 1 month before, during, and for 3 months after study participation

Expected Enrollment

A total of 20-50 patients will be accrued for this study within 20 months.

Outcomes

Anti-tumor immune response as assessed by ELISPOT assays, tetramer assays for T cell activity in peripheral blood mononuclear cells, and delayed type hypersensitivity skin test at 3 and 6 months
Safety and toxicity immediate and long-term

Tumor response rate and time to tumor progression by RECIST criteria at 3, 6, 9, and 12 months
Disease-free and overall survival at 3, 6, 9, and 12 months

Outline

Patients undergo surgical resection of malignant lymph nodes or systemic metastases (isolated metastases or symptomatic lesions) for collection of autologous tumor cells for vaccine production. Vaccine is formulated by combining equal volumes of irradiated autologous tumor cells and irradiated cells from a cell line producing sargramostim (GM-CSF) and expressing CD40L (GM.CD40L).

Patients receive vaccine comprising autologous tumor cells and GM.CD40L intradermally on day 1. Treatment repeats every 28 days for 3 courses. Patients with stable or responding disease at 3 months receive 3 additional courses of booster vaccine. Patients with no evidence of disease progression at 12 months receive 3 more courses of booster vaccine. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Sophie Dessureault, MD, PhD, Principal investigator		Ph: 813-745-3636; 888-663-3488 Email: sophie.dessureault@moffitt.org

Registry Information
Official Title		A Phase II Trial Using a Universal GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) in the Formulation of Autologous Tumor Cell-Based Vaccines for Patients with Malignant Melanoma
Trial Start Date		2004-10-26
Trial Completion Date		2008-10-01 (estimated)
Registered in ClinicalTrials.gov		NCT00101166
Date Submitted to PDQ		2004-11-05
Information Last Verified		2008-08-11
NCI Grant/Contract Number		CA76292