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Immunotherapy With Low Dose Interleukin-2 After Cytoreductive Chemotherapy for Patients With Hormone Refractory Metastatic Prostate Cancer: A Phase I/II Study

Phase 1/Phase 2
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

Immunotherapy With Low Dose Interleukin-2 After Cytoreductive Chemotherapy for Patients With Hormone Refractory Metastatic Prostate Cancer: A Phase I/II Study

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

- Medical history review and physical exam

- Blood tests for hematology, chemistries, PSA, and immune assays (approximately 4
tablespoons of blood)


- 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

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 >

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Celestia Higano, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Washington


United States: Institutional Review Board

Study ID:




Start Date:

September 2002

Completion Date:

July 2006

Related Keywords:

  • Prostate Cancer
  • Immunotherapy
  • Prostatic Neoplasms



Seattle Cancer Care Alliance Seattle, Washington  98109