Vaccine Therapy Plus Biological Therapy in Treating Patients With Prostate Cancer

NCT00016146 | Completed Phase 1

• 4 other identifiers: 99-062P30CA008748MSKCC-99062NCI-G01-1941
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

• safety

  2 years

Secondary Outcomes (1)

• immune function

  2 years

Study Arms (1)

vaccine

EXPERIMENTAL

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

Interventions

GPI-0100 BIOLOGICAL

vaccine

MUC-2-Globo H-KLH conjugate vaccine BIOLOGICAL

vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

GPI0100

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Susan Slovin, MD, PhD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2001
• First Posted: January 27, 2003
• Study Start: July 1, 2000
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 19, 2013

Record last verified: 2013-03

Locations

US (1)