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Vaccination Of Prostate Cancer Patients With A Bivalent Vaccine Containing MUC-2 Glycopeptide And Globo H Conjugates Plus The Immunological Adjuvant QS21


Phase 1
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

Vaccination Of Prostate Cancer Patients With A Bivalent Vaccine Containing MUC-2 Glycopeptide And Globo H Conjugates Plus The Immunological Adjuvant QS21


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

safety

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Susan Slovin, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

01-140

NCT ID:

NCT00036933

Start Date:

March 2002

Completion Date:

March 2009

Related Keywords:

  • Prostate Cancer
  • stage III prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021