Vaccine Therapy Plus QS21 in Treating Patients With Progressive Prostate Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy given with QS21 in treating patients who have progressive prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: QS21 Biological: TF(c)-KLH conjugate vaccine Biological: Thomsen-Friedenreich antigen Biological: keyhole limpet hemocyanin |
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 Thompson-Friedenreich [TF(c)]-KLH Conjugate Plus the Immunological Adjuvant QS21: A Trial Comparing TF(c)-KLH Doses |
- response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 21 |
| Study Start Date: | June 1998 |
| 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. Patients receive TF(c)-KLH conjugate with adjuvant QS21 subcutaneously weekly for 3 weeks, then once during weeks 7 and 19. Cohorts of 5 patients each receive escalating doses of TF(c)-KLH vaccine until the optimal dose, based on antibody response, is reached. Patients are followed monthly for 6 months, then every 3 months for 1 year.
|
Biological: QS21 Biological: TF(c)-KLH conjugate vaccine Biological: Thomsen-Friedenreich antigen Biological: keyhole limpet hemocyanin |
Detailed Description:
OBJECTIVES: I. Determine the optimal dose of Thompson-Friedenreich [TF(c)]-keyhole limpet hemocyanin (KLH) conjugate plus adjuvant QS21 that induces an antibody response in patients with prostate cancer. II. Determine the safety of the TF(c)-KLH conjugate prepared using an MBS heterobifunctional linker plus QS21. III. Assess postimmunization changes in prostate specific antigen levels and other objective parameters of disease in these patients.
OUTLINE: This is a dose escalation study. Patients receive TF(c)-KLH conjugate with adjuvant QS21 subcutaneously weekly for 3 weeks, then once during weeks 7 and 19. Cohorts of 5 patients each receive escalating doses of TF(c)-KLH vaccine until the optimal dose, based on antibody response, is reached. Patients are followed monthly for 6 months, then every 3 months for 1 year.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven progressive prostate cancer after primary therapy Radiographic changes OR PSA at least 1.0 ng/mL and rising after prostatectomy OR PSA at least 2.0 ng/mL and rising after radiotherapy OR PSA rising 50% during intermittent hormonal therapy No metastatic disease by radiography No active CNS or epidural tumor Registered on MSKCC-9040
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 6 months Hematopoietic: WBC at least 3500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL OR SGOT less than 3.0 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 40 mL/min Cardiovascular: No New York Heart Association class III/IV cardiac disease Pulmonary: No severe debilitating pulmonary disease Other: No other active malignancy within 5 years except nonmelanomatous skin cancer No infection requiring antibiotics No narcotic dependent pain No positive stool guaiac excluding hemorrhoids No radiation induced proctitis No allergy to seafood
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy and recovered No concurrent 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 serum concentration of suramin must be less than 50 micrograms/mL (replacement hydrocortisone allowed) Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No concurrent therapy to only measurable lesion Surgery: See Disease Characteristics No concurrent surgery
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00003819
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| 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: | NCT00003819 History of Changes |
| Other Study ID Numbers: | 98-048, P30CA008748, MSKCC-98048, NCI-G99-1510 |
| Study First Received: | November 1, 1999 |
| Last Updated: | March 18, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Memorial Sloan Kettering Cancer Center.:
|
stage I prostate cancer stage IIB prostate cancer stage IIA prostate cancer stage III prostate cancer recurrent prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Diseases, Male Genital Neoplasms, Male Neoplasms Neoplasms by Site Prostatic Diseases |
Urogenital Neoplasms Keyhole-limpet hemocyanin Adjuvants, Immunologic Immunologic Factors Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on February 27, 2015