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

Melanoma (Skin) Clinical Trial

Official title:

En Vivo Matured Dendritic Cell Therapy in Patients With Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00085488
• Other study ID #: CDR0000370802
• Secondary ID: DMS-9935DMS-1486
• Status: Completed
• Phase: Phase 1
• First received: June 10, 2004
• Last updated: January 30, 2015
• Start date: February 2004
• Est. completion date: February 2006

Study information

• Verified date: October 2005
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed melanoma

• Stage III (lymph node or in-transit metastases) or IV (systemic metastases) disease

• Patients with relapsed disease OR who failed prior immunotherapy or chemotherapy are eligible (but trial not restricted to relapsed or refractory disease)

• 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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• autologous tumor cell vaccine

• therapeutic autologous dendritic cells

Locations

Country	Name	City	State
United States	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ex Vivo Matured Dendritic Cell Therapy in Patients with Melanoma		2005-2006