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En Vivo Matured Dendritic Cell Therapy in Patients With Melanoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

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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 CenterLebanon, New Hampshire  03756-0002