Immunotherapy After Chemotherapy for Patients With Hormone Refractory Metastatic Prostate Cancer - Full Text View

Sponsors and Collaborators:	University of Washington Sanofi-Aventis
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00283829

Purpose

The purpose of this study is to test if interleukin-2, a drug that stimulates the immune system, can be used after chemotherapy to slow the progression of your disease. We also want to test what the best dose of interleukin-2 is that can be used safely at home.

Interleukin-2, abbreviated as IL2, is a naturally produced growth hormone for the immune cells in our body. It stimulates the growth of the immune cells and enhances their ability to fight infections and cancers. In people with cancer, the immune cells are typically suppressed and became even more so after irradiation and chemotherapy treatment. By giving you more IL2 we hope to enhance the immune system so that it can fight the cancer better, control cancer growth and shrink the cancer.

Condition	Intervention	Phase
Prostate Cancer	Drug: docetaxel Drug: IL2	Phase I Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Docetaxel Interleukin-2

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Immunotherapy With Low Dose Interleukin-2 After Cytoreductive Chemotherapy for Patients With Hormone Refractory Metastatic Prostate Cancer: A Phase I/II Study

Further study details as provided by University of Washington:

Primary Outcome Measures:

To determine the feasibility of sequencing low dose SQ IL-2 with chemotherapy in patients with hormone refractory prostate cancer (HRPC) in an outpatient setting. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine the impact of docetaxel on the natural immune defense system in patients before IL-2 administration. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	September 2002
Study Completion Date:	July 2006

Arms	Assigned Interventions
I Docetaxel followed by IL-2	Drug: docetaxel chemotherapy Drug: IL2 immunotherapy

Detailed Description:

There are two treatment phases in this study. But before you begin in the study, we will need to find out whether you are eligible for the study. You will undergo the following procedures.

Medical history review and physical exam
Blood tests for hematology, chemistries, PSA, and immune assays (approximately 4 tablespoons of blood)
EKG
CT scan of the abdomen and pelvis and a bone scan
Complete a pain questionnaire, quality of life questionnaire, pain medication diary, and symptom diary

The initial treatment phase of this study consists of chemotherapy drug given weekly. You will receive 3 weekly chemotherapy treatments followed by 1 week with no treatment. Three weeks of treatment followed by one week of no treatment is considered 1 cycle, and you will receive a total of 4 cycles of chemotherapy over a 16-week period. Taxotere is given intravenously in the clinic on the 1st day of each weekly treatment.

Treatment with taxotere is a currently accepted treatment for this stage prostate cancer. Your doctor may recommend you receive taxotere even if you do not participate in this study. During this phase of treatment, you will have blood draws on treatment weeks prior to having the chemotherapy. You will have a PSA drawn every month (weeks 5, 9, and 13). We will ask you to complete a pain questionnaire, quality of life questionnaire, pain medication diary, and symptom diary at weeks 5, 9, and 13. Some of the questions may be personal, such as "I am satisfied with my sex life" and "I worry about dying". You do not have to answer these questions if you do not want to. You will also have a physical exam at the beginning of your 3rd cycle of treatment (week 9).

The second phase of the treatment program is the experimental part: immunotherapy with IL2. You will be assigned to receive one of 4 doses of IL2. This is because we are testing what is the highest dose of IL2 that a subject can receive without having unacceptable side affects from the IL2. You will give yourself shots of IL2 under the skin twice a day for 5 days per week for 3 weeks. During the 3rd week of treatment there are 2 days when you have to give a higher dose of IL2 for boosting the immune cells (see below diagram). The 4th week will be a rest week where you do not receive treatment. One 4-week period of IL2 treatment is called a cycle. You will continue to receive cycles of IL2 treatment as long as your cancer shows no further growth. We will teach you how to administer the IL2 at home.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients are age >18 years with histological diagnosis of prostate cancer
Hormone refractory disease with at least 2 serial rises in PSA with a castrate level of testosterone (< 50ng/dL). Primary hormonal therapy will be continued.
Patients must have metastatic disease as evidenced by soft tissue or bony metastasis
Patients have an ECOG performance status of 0, 1, 2
Patients must have preserved organ function
Bilirubin < ULN and serum creatinine 1.5 x ULN, transaminases (SGOT and/or SGPT) may be up to 2.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are ULN.
Patients must be off chronic steroid treatment for at least 2 weeks, and pre-/post-chemotherapy steroid medication for at least 1 week
Patients may not receive Taxanes previously.
Patients must be able to complete pain and quality of life scales.
Ancillary treatments, such as bisphosphonate, pain medication is allowed, but natural herbal, homeopathic supplements such as MGN-3 is not allowed.
Absolute neutrophil count > 1,500/mm3, hemoglobin > 8.0 g/dl, platelet count > 100,000/mm3.
Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for a 12 month period thereafter.

Exclusion Criteria:

Patients on chronic steroid medication
Spine radiation therapy for cord compression within 2 weeks of study entry
Concurrent use of other investigational therapy
Prior immunotherapy with IL2 or alpha-interferon within 30 days
Peripheral neuropathy > Grade 1
Other active malignancy, except non-melanotic skin cancer
Significant active medical illness or psychosocial condition that in the opinion of the investigator would preclude protocol treatment.
Hypersensitivity to drugs formulated with polysorbate-80
Patients with contraindications to Coumadin or aspirin.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00283829

Locations

United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109

Sponsors and Collaborators

University of Washington

Sanofi-Aventis

Investigators

Principal Investigator:

Celestia Higano, MD

University of Washington

More Information

Research Studies : Specific Diseases or Conditions This link exits the ClinicalTrials.gov site

Responsible Party:	University of Washington ( Celestia Higano, MD )
Study ID Numbers:	02-3017-A-04, IIT-16117, USI-IL2-01-012
Study First Received:	January 26, 2006
Last Updated:	November 28, 2007
ClinicalTrials.gov Identifier:	NCT00283829
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Washington:

Immunotherapy

Study placed in the following topic categories:

Docetaxel
Prostatic Diseases
Genital Neoplasms, Male
Interleukin-2

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009