NCT00283829

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for phase_1 prostate-cancer

Timeline
Completed

Started Sep 2002

Typical duration for phase_1 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

November 29, 2007

Status Verified

November 1, 2007

First QC Date

January 26, 2006

Last Update Submit

November 28, 2007

Conditions

Prostate Cancer

Keywords

Immunotherapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years

Secondary Outcomes (1)

  • To determine the impact of docetaxel on the natural immune defense system in patients before IL-2 administration.

    2 years

Study Arms (1)

I

OTHER

Docetaxel followed by IL-2

Drug: docetaxelDrug: IL2

Interventions

docetaxelDRUG

chemotherapy

Also known as: taxotere
I
IL2DRUG

immunotherapy

Also known as: Interleukin
I

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

DocetaxelInterleukin-2Interleukins

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological Factors

Study Officials

  • Celestia Higano, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 26, 2006

First Posted

January 30, 2006

Study Start

September 1, 2002

Study Completion

July 1, 2006

Last Updated

November 29, 2007

Record last verified: 2007-11

Locations

US(1)