Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00010127
• Other study ID #: 0759
• Secondary ID: DUMC-000759-00-4
• Status: Terminated
• Phase: Phase 1
• First received: February 2, 2001
• Last updated: March 19, 2013
• Start date: November 2000
• Est. completion date: March 2003

Study information

• Verified date: December 2008
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill prostate tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• therapeutic autologous dendritic cells

Locations

Country	Name	City	State
United States	Duke Comprehensive Cancer Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,