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A Pilot Multivalent Conjugate Vaccine Trial For Patients With Biochemically Relapsed Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Pilot Multivalent Conjugate Vaccine Trial For Patients With Biochemically 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Susan Slovin, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068596

NCT ID:

NCT00016120

Start Date:

June 2000

Completion Date:

Related Keywords:

  • Prostate Cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021