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A Safety and Feasibility Study of Active Immunotherapy in Patients With Metastatic Prostate Carcinoma Using Autologous Dendritic Cells Pulsed With Antigen Encoded in Amplified Autologous Tumor RNA


Phase 1
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

A Safety and Feasibility Study of Active Immunotherapy in Patients With Metastatic Prostate Carcinoma Using Autologous Dendritic Cells Pulsed With Antigen Encoded in Amplified Autologous Tumor RNA


OBJECTIVES:

- Determine the safety and feasibility of autologous dendritic cells transfected with
autologous total tumor RNA in patients with metastatic prostate cancer.

- Determine the presence, frequency, and activation status of tumor specific and prostate
specific antigen (PSA) specific cellular immune responses in patients treated with this
regimen.

- Determine delayed-type hypersensitivity reactions to PSA protein and other recall
antigens in patients before and after being treated with this regimen.

- Determine clinical responses based on clinical and biochemical (PSA) response criteria
in patients treated with this regimen.

- Determine a platform for immunological treatment using dendritic-cell based tumor
vaccines in these patients.

OUTLINE: This is a dose escalation study.

Tumor tissue and peripheral blood stem cells are collected from patients and cultured in
vitro with sargramostim (GM-CSF) and interleukin-4 for 7 days to produce dendritic cells
(DC). Patients receive autologous DC transfected with autologous prostate carcinoma RNA
intradermally once weekly on weeks 0-3 for a total of 4 doses.

Cohorts of 3-6 patients receive escalating doses of DC until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity.

Patients are followed at weeks 6, 8, 10, and 12; every 3 months for 9 months; and then
annually for 2 years.

PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study within 20 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic adenocarcinoma of the prostate

- Stage D1-3

- Regional lymph node, bone, visceral, or soft tissue metastases

- No transitional cell or small cell carcinoma

- Testosterone less than 50 mg/L if prior treatment with luteinizing hormone releasing
hormone (LHRH) analogues or estrogens

- Evidence of androgen refractory disease after surgical castration and discontinuation
of LHRH analogue therapy

- No previously irradiated or new CNS metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 70-100%

Life expectancy:

- More than 6 months

Hematopoietic:

- WBC at least 3,000/mm^3

- Hemoglobin at least 9 g/dL

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin less than 2.0 mg/dL

- PT at least 11.3 seconds but no greater than 13.3 seconds

- PTT at least 20.1 seconds but no greater than 32.9 seconds

- No hepatic disease

- No viral hepatitis

Renal:

- Creatinine less than 2.5 mg/dL

Cardiovascular:

- No New York Heart Association class III or IV heart disease

Pulmonary:

- No asthma

- No chronic obstructive pulmonary disease

- No severe lung disease

Other:

- No other medical illness or psychological impediment that would preclude study

- No other concurrent malignancy except nonmelanoma skin cancer or controlled
superficial bladder cancer

- No active acute or chronic infection including symptomatic urinary tract infection

- No autoimmune disease (e.g., inflammatory bowel disease, systemic lupus
erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, or multiple
sclerosis)

- HIV negative

- Adequate peripheral vein access

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Prior biologic therapy allowed

- No other concurrent immunotherapy

Chemotherapy:

- Prior chemotherapy allowed

- No concurrent chemotherapy

Endocrine therapy:

- See Disease Characteristics

- At least 4 weeks since prior non-steroidal hormonal therapy if increase in PSA while
receiving non-steroidal hormonal therapy

- At least 6 weeks since prior steroids

- Concurrent LHRH analogues for gonadal androgen suppression allowed

- No concurrent steroid therapy

- No concurrent corticosteroids

Radiotherapy:

- See Disease Characteristics

- Prior palliative radiotherapy for bone metastases allowed

- Prior prostatic radiotherapy allowed

- At least 4 weeks since prior radiotherapy

- At least 12 weeks since prior strontium chloride Sr 89

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

Other:

- Recovered from prior therapy

- No concurrent immunosuppressive agents (e.g., azathioprine or cyclosporine)

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Johannes Vieweg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute

Authority:

United States: Federal Government

Study ID:

0759

NCT ID:

NCT00010127

Start Date:

November 2000

Completion Date:

March 2003

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IV prostate cancer
  • Prostatic Neoplasms

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710