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Vaccine Therapy Plus Biological Therapy in Treating Patients With Relapsed Prostate Cancer
This study is ongoing, but not recruiting participants.
Study NCT00016120   Information provided by National Cancer Institute (NCI)
First Received: May 6, 2001   Last Updated: February 6, 2009   History of Changes

May 6, 2001
February 6, 2009
June 2000
 
 
 
Complete list of historical versions of study NCT00016120 on ClinicalTrials.gov Archive Site
 
 
 
Vaccine Therapy Plus Biological Therapy in Treating Patients With Relapsed Prostate Cancer
A Pilot Multivalent Conjugate Vaccine Trial For Patients With Biochemically Relapsed Prostate Cancer

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

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

OBJECTIVES:

  • Determine the safety of a multivalent conjugate vaccine comprising Globo H, GM2, Lewis-y, MUC-1-32-mer, TF(c), and Tn(c) antigens conjugated to keyhole limpet hemocyanin (KLH) with adjuvant QS21 in patients with biochemically relapsed prostate cancer.
  • Measure the antibody response against the individual components of the vaccine and correlate the response to subsequent clinical course in patients treated with this vaccine.
  • Assess post-immunization changes in prostate-specific antigen levels and other objective parameters of the disease in these patients.

OUTLINE: Patients receive Globo H, MUC-1-32mer, GM2, Lewis-y, Tn(c), TF(c)-KLH conjugate vaccine with adjuvant QS21 subcutaneously weekly on weeks 1, 2, 3, 7, 19, 31, 43, and 55.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 6 months.

Phase II
Interventional
Treatment
Prostate Cancer
  • Biological: Globo H-GM2-Lewis-y-MUC1-32-mer-TF(c)-Tn(c)-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
  • Biochemically progressive disease after primary therapy, including surgery or radiotherapy, with or without neoadjuvant androgen ablation

    • Log of prostate-specific antigen (PSA) slope greater than 0.15 as determined by at least 3 measurements taken at 2-week intervals within 12 months
    • Minimal baseline PSA value prior to study:

      • Post-prostatectomy: 0.1 ng/mL
      • Post-radiotherapy: 1.0 ng/mL
      • Intermittent hormonal therapy: 1.0 ng/mL
  • Patients with prior intermittent hormonal therapy after primary therapy and non-castrate levels of testosterone (greater than 50 ng/mL) are eligible
  • No radiographic evidence of metastatic disease
  • Concurrent registration to MSKCC-90040 required

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 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 clinically significant cardiac disease (New York Heart Association class III-IV)

Pulmonary:

  • No severe debilitating pulmonary disease

Other:

  • No other prior malignancy within the past 5 years except nonmelanoma skin cancer or melanoma in situ
  • No allergy to seafood
  • No narcotic-dependent pain
  • No infection requiring antibiotics
  • No positive stool guaiac except hemorrhoids or history of documented radiation induced proctitis

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior vaccine therapy except on phase I monovalent trial at Memorial Sloan Kettering Cancer Center

Chemotherapy:

  • At least 4 weeks since prior chemotherapy

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

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

Surgery:

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

Other:

  • Recovered from prior therapy
  • No other concurrent oncolytic agents
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00016120
 
CDR0000068596, MSKCC-00064, NCI-G01-1940
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Susan Slovin, MD, PhD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
December 2003

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