En Vivo Matured Dendritic Cell Therapy in Patients With Melanoma
18 Years
N/A
Both
Melanoma (Skin)
Trial Information
En Vivo Matured Dendritic Cell Therapy in Patients With Melanoma
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Christopher P.G. Tretter, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Norris Cotton Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000370802
NCT ID:
NCT00085488
Start Date:
February 2004
Completion Date:
Related Keywords:
- Melanoma (Skin)
- recurrent melanoma
- stage III melanoma
- stage IV melanoma
- Melanoma
Name | Location |
|---|---|
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
