Prostate CancerPhase 1NCT00036933
Vaccine Therapy Plus QS21 in Treating Patients With Prostate Cancer
A Phase 1 study testing MUC-2-Globo H-KLH conjugate vaccine and QS21 in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MUC-2-Globo H-KLH conjugate vaccine and QS21
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2002to Mar 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Vaccination Of Prostate Cancer Patients With A Bivalent Vaccine Containing MUC-2 Glycopeptide And Globo H Conjugates Plus The Immunological Adjuvant QS21
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.
Read the detailed description
OBJECTIVES:
- Determine the safety of glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant QS21 in patients with prostate cancer.
- Determine the antibody response in patients treated with this vaccination therapy.
- Assess post-immunization changes in PSA levels and other objective parameters of disease (radionuclide bone scan) in patients treated with this vaccination therapy.
OUTLINE: 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.
- Conditions
- Prostate Cancer
- Being tested
- MUC-2-Globo H-KLH conjugate vaccine, QS21
- Keywords
- stage III prostate cancer, recurrent prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MUC-2-Globo H-KLH conjugate vaccineBiological
QS21Biological
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: MUC-2-Globo H-KLH conjugate vaccine; Biological: QS21 |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety
Measured: 2 years
Secondary outcomes (1)
response
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMar 2002
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Susan Slovin, MD, PhD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036933
- Sponsor's protocol ID
- 01-140
- Other IDs
- P30CA008748, MSKCC-01140, NCI-G02-2064
- Status last verified
- Mar 2013
- First submitted
- 13 May 2002
- Last updated
- 25 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccination Of Prostate Cancer Patients With A Bivalent Vaccine Containing MUC-2 Glycopeptide And Globo H Conjugates Plus The Immunological Adjuvant QS21
- ClinicalTrials.gov ID
- NCT00036933
- Acronym / sponsor ID
- 01-140
- Conditions
- Prostate Cancer
- Keywords
- stage III prostate cancer, recurrent prostate cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2002
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- Determine the safety of glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant QS21 in patients with prostate cancer.
- Determine the antibody response in patients treated with this vaccination therapy.
- Assess post-immunization changes in PSA levels and other objective parameters of disease (radionuclide bone scan) in patients treated with this vaccination therapy.
OUTLINE: 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vaccine | Experimental | Biological: MUC-2-Globo H-KLH conjugate vaccine, Biological: QS21Patients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MUC-2-Globo H-KLH conjugate vaccine | Biological | vaccine |
| QS21 | Biological | vaccine |
Primary outcome
safety
Time frame: 2 years
1 secondary outcome
response
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Slovin, MD, PhD study chair
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MUC-2-Globo H-KLH conjugate vaccine and QS21 in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2013.