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Vaccine Therapy Plus Biological Therapy in Treating Patients With Relapsed Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00016120
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Globo H-GM2-Lewis-y-MUC1-32-mer-TF(c)-Tn(c)-KLH conjugate vaccine
Drug: QS21
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: QS 21
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Pilot Multivalent Conjugate Vaccine Trial For Patients With Biochemically Relapsed Prostate Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2000
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00016120

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Susan Slovin, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Slovin S, Ragupathi G, Clarke T, et al.: Multivalency in a phase II prostate cancer (PC) vaccine trial: are more antigens better? [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-671, 2003.

Study ID Numbers: CDR0000068596, MSKCC-00064, NCI-G01-1940
Study First Received: May 6, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00016120  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent prostate cancer

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
QS 21
Genital Diseases, Male
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009