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Vaccine Therapy Plus Biological Therapy in Treating Patients With Prostate Cancer - Article


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Vaccine Supply, Delays and Shortages


Clinical Trial: Vaccine Therapy Plus Biological Therapy in Treating Patients With Prostate Cancer

This study is no longer recruiting patients.

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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 I trial to study the effectiveness in combining vaccine therapy and biological therapy in treating patients who have relapsed prostate cancer.

Condition Treatment or Intervention Phase
recurrent prostate cancer
 Drug: GPI-0100
 Drug: MUC-2-Globo H-KLH conjugate vaccine
 Procedure: biological response modifier therapy
 Procedure: non-specific immune-modulator therapy
 Procedure: non-tumor cell derivative vaccine
 Procedure: vaccine therapy
Phase I

MedlinePlus related topics:  Prostate Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of Glycosylated MUC-2-Globo H-KLH Conjugate Vaccine With Adjuvant GPI-0100 in Patients With Biochemically Relapsed Prostate Cancer

Further Study Details: 

OBJECTIVES:

  • Determine the optimal (in terms of antibody response) and safe dose range of glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant GPI-0100 in patients with biochemically relapsed prostate cancer.
  • Assess post-immunization changes in prostate-specific antigen levels and other objective parameters of disease in these patients.

OUTLINE: This is a dose-escalation study of GPI-0100.

Patients receive glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant GPI-0100 subcutaneously weekly on weeks 0-2, 6, 14, and 26 in the absence of unacceptable toxicity or disease progression.

Cohorts of 5 patients receive escalating doses of GPI-0100 until the optimal dose, based on antibody response, is reached.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer
  • Biochemically progressive disease after primary surgery or radiotherapy with or without neoadjuvant androgen ablation
  • Greater than 50% increase in PSA level above baseline value of 1.0 ng/mL post-prostatectomy or 2.0 ng/mL post-radiotherapy, based on 3 successive determinations taken at 2-week intervals
  • Patients with prior intermittent hormonal therapy and non-castrate levels of testosterone are eligible
  • Evaluable disease
  • No radiographic evidence of metastasis
  • 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
  • Concurrent registration to protocol MSKCC-90-040 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 or IV)

Pulmonary:

Other:

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

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 4 weeks since prior chemotherapy

Endocrine therapy:

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:


Location Information


New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

Susan Slovin, MD, PhD,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068598; MSKCC-99062; NCI-G01-1941
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  May 6, 2001
ClinicalTrials.gov Identifier:  NCT00016146
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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August 22, 2008



Page Updated: June 12, 2007
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