Vaccine Therapy Plus Biological Therapy in Treating Patients With Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00016146
First received: May 6, 2001
Last updated: March 18, 2013
Last verified: March 2013
  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 Intervention Phase
Prostate Cancer
Biological: GPI-0100
Biological: MUC-2-Globo H-KLH conjugate vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vaccination Of Prostate Cancer Patients With A Bivalent Vaccine Containing MUC-2 Glycopeptide And Globo H Conjugates: A Dose-Escalating Trial Studying The Immunogenicity And Safety Of The Immunological Adjuvant GPI-0100

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • immune function [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: July 2000
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vaccine

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.

Biological: GPI-0100 Biological: MUC-2-Globo H-KLH conjugate vaccine

Detailed Description:

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.

  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 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:

  • No severe debilitating pulmonary disease

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:

  • See Disease Characteristics
  • At least 2 weeks since change in hormonal therapy (except to maintain castrate levels of testosterone), including prednisone or dexamethasone
  • At least 8 weeks since prior suramin and/or documented plasma concentration
  • of suramin is less than 50 micrograms/mL (replacement hydrocortisone allowed)

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
  • No concurrent immunosuppressive therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00016146

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

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00016146     History of Changes
Other Study ID Numbers: 99-062, P30CA008748, MSKCC-99062, NCI-G01-1941
Study First Received: May 6, 2001
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on October 19, 2014