Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma

NCT ID: NCT00085488

Last Updated: 2015-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2006-02-28

Brief Summary

RATIONALE: Vaccines made from a patient's dendritic cells and tumor cells may make the body build an immune response to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage III or stage IV melanoma.

Detailed Description

OBJECTIVES:

Primary

• Determine the dose-limiting toxicity and the maximum tolerated dose of autologous dendritic cells pulsed with autologous tumor cell lysate in patients with stage III or IV melanoma.
• Determine the safety and tolerability of this therapy in these patients.

Secondary

• Determine the immune response, in terms of the type and degree of T-cell proliferation and delayed-type hypersensitivity responses, in patients treated with this therapy.

OUTLINE: This is a dose-escalation, pilot study.

Patients undergo leukapheresis for the collection of peripheral blood mononuclear cells (PBMC) on days -9, 19, and 47. Autologous dendritic cells (DC) are prepared from autologous PBMC exposed to sargramostim (GM-CSF), interleukin-4, and tumor necrosis factor alpha and pulsed with autologous tumor cell lysate. Patients receive autologous tumor cell lysate-pulsed DC IV over 5-10 minutes on days 0, 28, and 56.

Cohorts of 3-6 patients receive escalating doses of autologous tumor cell lysate-pulsed DC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 33% of all patients experience dose-limiting toxicity.

Patients are followed at day 84 and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 3-20 patients will be accrued for this study within 3-20 months.

Conditions

Melanoma (Skin)

Study Design

• Primary Study Purpose: TREATMENT

Interventions

autologous tumor cell vaccine

Intervention Type: BIOLOGICAL

therapeutic autologous dendritic cells

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Tumor tissue available and properly stored for lysate preparation

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute neutrophil count ≥ 1,000/mm^3
• Platelet count ≥ 75,000/mm^3

Hepatic

• AST ≤ 2 times upper limit of normal (ULN) (3 times ULN for liver metastases)
• Bilirubin ≤ 2 times ULN
• Hepatitis B surface antigen negative
• Hepatitis C negative

Renal

• Creatinine ≤ 2.0 times ULN

Immunologic

• No active infection
• No history of autoimmune disease, including any of the following:

• Inflammatory bowel disease
• Systemic lupus erythematosus
• Scleroderma
• Rheumatoid arthritis
• Multiple sclerosis
• No allergy to aminoglycosides or streptomycin
• HIV negative

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No significant comorbid illness
• No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics
• At least 10 days since prior immunotherapy

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• At least 6 weeks since prior steroid therapy
• No concurrent corticosteroids

Radiotherapy

• At least 10 days since prior radiotherapy
• No concurrent radiotherapy

Surgery

• At least 10 days since prior surgery
• Prior diagnostic or palliative surgery allowed provided the patient has fully recovered

Other

• No concurrent immunosuppressive or potentially immunosuppressive therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher P. Tretter, MD

Role: STUDY_CHAIR

Norris Cotton Cancer Center

Locations

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Countries

United States

Other Identifiers

DMS-9935

Identifier Type: -

Identifier Source: secondary_id

DMS-14862

Identifier Type: -

Identifier Source: secondary_id

CDR0000370802

Identifier Type: -

Identifier Source: org_study_id