Multivalent Conjugate Vaccine Trial for Patients With Biochem. Relapsed Prostate Cancer

NCT00579423 | Completed Phase 2 DMC

• 1 other identifier: 00-064
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot trial designed to assess safety and immunogenicity of a multivalent conjugate vaccine for use in patients with biochemically relapsed prostate cancer.

Conditions

Prostate; Cancer

Keywords

prostate; cancer; vaccine

Outcome Measures

Primary Outcomes (1)

• Overall antitumor assessment performed during weeks 19 and 31. If no progression of disease continue on protocol. After week 31, will be monitored every 3 months with history, physical, performance status and bloodwork. Imaging studies every 6 mo.

  11/2000-12/2008

Study Arms (1)

vaccine

EXPERIMENTAL

Patients will be treated with specified doses of each carbohydrate or peptide constituent as has been determined. QS21 will be administrated at the standard dose of 100ug.

Biological: QS21

Interventions

QS21 BIOLOGICAL

* Treatment schedule and dose: Thirty patients will be treated with specified doses of each carbohydrate or peptide constituent as has been determined. QS21 will be administered at the standard dose of 100 ug. * Sites: The vaccine conjugate will be administered subcutaneously on a rotating basis to random sites on the upper arms and upper legs. * Dose modifications: If a patient experiences a Grade III or greater local or Grade II or greater systemic toxicity at any time a decrease by 50% in all components of future vaccinations will be administered for that patient. Any evidence of autoimmunity, however, will result in a cessation of immunization in that patient.

vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with prostate cancer that is histologically confirmed.
• Patients must show biochemical progression after primary therapy, including surgery or radiation (with or without neo-adjuvant androgen ablation). This detection of PSA following treatment must occur within two years.
• Patients who have had intermittent hormonal treatment, following primary therapy, who have non-castrate levels of testosterone (\>50 ng/ml) are eligible. Hormonal status will be recorded on the basis of serum testosterone levels.
• Karnofsky performance status \>60%.
• Patients must have adequate organ function as defined by:
• WBC \> or = to 3500/mm3, platelet count \> or = to 100,000 mm3.
• Bilirubin \<2.0 mg/100 ml or SGOT \<3.0 X's the upper limit of normal.
• Creatinine \< or = to 2.0 mg/100 ml or creatinine clearance \> or = to 40 cc/min.
• Patients must have recovered from the toxicity of any prior therapy, and not received chemotherapy or radiation therapy for at least 4 weeks prior to entry into the trial.
• No history of an active secondary malignancy within the prior five years except for nonmelanoma skin cancer. Patients with history of melanoma in situ will be permitted since these lesions behave in a manner similar to compound nevi.
• Patients must be at least 18 years of age.
• Patients must sign informed consent.

You may not qualify if:

• Clinically significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease.
• Radiographic evidence of metastatic disease.
• An infection requiring antibiotic treatment.
• Narcotic dependent pain.
• Anticipated survival of less than 6 months.
• Positive stool guaiac excluding hemorrhoids or history of documented radiation induced proctitis.
• Allergy to seafood.
• Prior vaccine therapy at outside institution except for phase I monovalent trial performed at MSKCC.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Capcure: collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Neoplasms

Interventions

saponin QA-21V1

Study Officials

• Susan Slovin, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 24, 2007
• Study Start: November 1, 2000
• Primary Completion: May 1, 2003
• Study Completion: March 1, 2009
• Last Updated: October 5, 2023

Record last verified: 2023-10

Locations

US (1)