Vaccine Therapy Plus QS21 in Treating Patients With Prostate Cancer

NCT00036933 | Completed Phase 1

• 4 other identifiers: 01-140P30CA008748MSKCC-01140NCI-G02-2064
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Biological therapies such as QS21 use different ways to stimulate the immune system and stop cancer cells from growing. Combining vaccine therapy with QS21 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with QS21 in treating patients who have prostate cancer.

Conditions

Prostate Cancer

Keywords

stage III prostate cancer; recurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

• safety

  2 years

Secondary Outcomes (1)

• response

  2 years

Study Arms (1)

vaccine

EXPERIMENTAL

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.

Biological: MUC-2-Globo H-KLH conjugate vaccine; Biological: QS21

Interventions

MUC-2-Globo H-KLH conjugate vaccine BIOLOGICAL

vaccine

QS21 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 * 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

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

saponin QA-21V1

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 13, 2002
• First Posted: January 27, 2003
• Study Start: March 1, 2002
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 25, 2013

Record last verified: 2013-03

Locations

US (1)