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Vaccine Therapy Plus QS21 in Treating Patients With Prostate Cancer
This study is ongoing, but not recruiting participants.
Study NCT00036933   Information provided by National Cancer Institute (NCI)
First Received: May 13, 2002   Last Updated: February 6, 2009   History of Changes

May 13, 2002
February 6, 2009
March 2002
 
 
 
Complete list of historical versions of study NCT00036933 on ClinicalTrials.gov Archive Site
 
 
 
Vaccine Therapy Plus QS21 in Treating Patients With Prostate Cancer
Vaccination Of Prostate Cancer Patients With A Bivalent Vaccine Containing MUC-2 Glycopeptide And Globo H Conjugates Plust The Immunological Adjuvant QS21

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Biological therapies such as QS21 use different ways to stimulate the immune system and stop cancer cells from growing. Combining vaccine therapy with QS21 may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with QS21 in treating patients who have prostate cancer.

OBJECTIVES:

  • Determine the safety of glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant QS21 in patients with prostate cancer.
  • Determine the antibody response in patients treated with this vaccination therapy.
  • Assess post-immunization changes in PSA levels and other objective parameters of disease (radionuclide bone scan) in patients treated with this vaccination therapy.

OUTLINE: Patients receive glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant QS21 subcutaneously once weekly on weeks 0-2, 6, 14, and 26 in the absence of unacceptable toxicity. Patients whose antibody titers against Globo-H or MUC-2 antigens fall below 1/40 and who have no disease progression may receive a seventh vaccination after week 50.

Patients are followed every 3 months for 1 year or until biochemical relapse or radiographic disease progression.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 2 months.

Phase II
Interventional
Treatment
Prostate Cancer
  • Biological: MUC-2-Globo H-KLH conjugate vaccine
  • Biological: QS21
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer
  • Disease progression after primary surgery (radical prostatectomy) or radiotherapy with or without prior neoadjuvant androgen ablation

    • Minimum of 3 rising PSA values, taken at least 2 weeks apart, with more than a 50% rise in PSA level above the baseline value (1.0 ng/mL post -prostatectomy or 2.0 ng/mL post-radiotherapy)
    • Received prior intermittent hormonal therapy after prior primary therapy
    • Non-castrate levels of testosterone (more than 50 ng/mL)
  • Evaluable disease (by serial changes in PSA)
  • No radiographic evidence of metastatic disease
  • No active CNS or epidural tumor
  • No soft tissue and/or bone disease
  • No androgen-independence with no evidence of radiographic disease
  • May not be symptomatic or anticipated to develop symptoms within 6 months of study entry

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 6 months

Hematopoietic:

  • WBC at least 3,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin less than 2.0 mg/dL
  • 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 clinically significant cardiac disease (New York Heart Association class III or IV)

Pulmonary:

  • No severe debilitating pulmonary disease

Other:

  • No allergy to seafood (shellfish)
  • No other active malignancy within the past 5 years except nonmelanoma skin cancer
  • No infection requiring antibiotics
  • No narcotic-dependent pain
  • No positive stool guaiac unless associated with hemorrhoids or prior documented radiation-induced proctitis

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 4 weeks since prior chemotherapy

Endocrine therapy:

  • See Disease Characteristics
  • See Chemotherapy
  • At least 2 weeks since change in hormonal therapy (e.g., prednisone or dexamethasone) except to maintain castrate levels of testosterone

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • No concurrent irradiation of only measurable lesion

Surgery:

  • See Disease Characteristics
  • No concurrent surgery of only measurable lesion

Other:

  • Recovered from prior therapy
  • At least 8 weeks since prior suramin and/or documented plasma concentration of suramin if less than 50 micrograms/mL (replacement hydrocortisone allowed)
  • No other concurrent oncolytic agents
  • No concurrent immunosuppressive therapy
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00036933
 
CDR0000069342, MSKCC-01140, NCI-G02-2064
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Susan Slovin, MD, PhD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
March 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP