NCT00004929

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy given with QS21 in treating patients who have progressive prostate cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at P25-P50 for phase_1 prostate-cancer

Timeline
Completed

Started Sep 1999

Longer than P75 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, 1999

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2000

Completed
4.3 years until next milestone

First Posted

Study publicly available on registry

June 18, 2004

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

January 31, 2013

Status Verified

January 1, 2013

Enrollment Period

8.8 years

First QC Date

March 7, 2000

Last Update Submit

January 30, 2013

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer

Study Arms (1)

Vaccine

EXPERIMENTAL

Patients receive vaccination with glycosylated MUC-2 antigen with keyhole limpet hemocyanin conjugate subcutaneously (SQ) plus immunological adjuvant QS21 SQ on weeks 1-3, 7, 15, and 27 for a total of 6 vaccinations. Patients are followed every 3 months for 1 year or until disease progression.

Biological: MUC-2-KLH vaccineBiological: QS21

Interventions

MUC-2-KLH vaccineBIOLOGICAL
Vaccine
QS21BIOLOGICAL
Vaccine

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed prostate cancer Disease progression with 3 or more rising PSA levels at least 2 weeks apart with greater than 50% rise above the baseline PSA, despite prostatectomy or radiotherapy Disease progression following primary therapy including surgery or radiotherapy with or without neoadjuvant androgen ablation allowed OR Intermittent hormonal therapy with noncastrate levels of testosterone (greater than 50 ng/mL) allowed No soft tissue and/or bone disease OR No androgen independence without evidence of radiographic disease No change in hormonal therapies (excluding therapies to maintain castrate testosterone levels) including prednisone or dexamethasone within 2 weeks of study No symptomatic or anticipatory (within 6 months) symptomatic disease No active CNS or epidural tumor No radiographic evidence of metastatic disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 6 months Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL OR SGOT less than 3 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 40 mL/min Cardiovascular: No New York Heart Association class III or IV heart disease Pulmonary: No severe debilitating pulmonary disease Other: No other active malignancy within the past 5 years except nonmelanoma skin cancer No infection requiring antibiotics No seafood allergies No positive stool guaiac except for hemorrhoids or history of radiotherapy induced proctitis No narcotic dependent pain PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy and recovered At least 8 weeks since prior suramin and/or plasma concentration below 50 microgram/mL Endocrine therapy: See Disease Characteristics Recovered from prior hormonal therapy Concurrent replacement hydrocortisone following prior suramin allowed Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics Recovered from prior surgery

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

MUC-2-KLH vaccinesaponin QA-21V1

Condition Hierarchy (Ancestors)

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

Study Officials

  • Susan Slovin, MD, PhD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2000

First Posted

June 18, 2004

Study Start

September 1, 1999

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

January 31, 2013

Record last verified: 2013-01

Locations

US(1)