SarcomaPhase 2NCT00005628
Vaccine Therapy in Treating Patients With Recurrent Soft Tissue Sarcoma
A Phase 2 study testing vitespen in people with Sarcoma, 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. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have recurrent soft tissue sarcoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- vitespen
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Nov 1999to Aug 2001
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically confirmed recurrent soft tissue sarcoma Incompletely or completely resected metastatic or locally recurrent disease (surgery must be performed with intent of complete resection) No active brain metastases
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 70-100% Life expectancy: At least 16 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,000/mm3 Platelet count at least 80,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease Other: No active infections requiring antibiotics within 2 weeks of study No other serious medical illness requiring hospitalization No history of primary or secondary immunodeficiency or autoimmune disease No contraindications to MRI (e.g., aneurysm clips or cardiac pacemakers) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior immunotherapy and recovered Chemotherapy: At least 6 weeks since prior chemotherapy and recovered Endocrine therapy: No concurrent systemic corticosteroids Radiotherapy: At least 6 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics No prior splenectomy Other: At least 6 weeks since other prior experimental anticancer therapy and recovered No concurrent non-steroidal anti-inflammatory drugs or other immunosuppressive drugs No other concurrent participation in a clinical trial
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: A Phase II Trial of Active Specific Immunotherapy in Patients With Recurrent Soft Tissue Sarcoma Using Autologous Tumor-derived Heat Shock Protein-Peptide Complex (HSPPC-96)
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have recurrent soft tissue sarcoma.
Read the detailed description
OBJECTIVES: I. Determine the efficacy of autologous tumor cell-derived heat shock protein peptide vaccine in terms of the rate of complete and partial response and time to progression in patients with recurrent soft tissue sarcoma. II. Determine the safety and tolerability of this treatment regimen in this patient population. III. Determine the anti-tumor response to this treatment regimen in these patients.
OUTLINE: At approximately 5 weeks after surgery, patients receive autologous tumor cell-derived heat shock protein peptide vaccine intradermally weekly for 4 weeks. Patients receive subsequent vaccinations once every 2 weeks for at least 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with improving or stable disease or without recurrence continue on therapy for up to 1 year.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
- Conditions
- Sarcoma
- Being tested
- vitespen
- Keywords
- recurrent adult soft tissue sarcoma, stage IV adult soft tissue sarcoma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitespenBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2004 (estimated)
- Study startNov 1999
- Primary completionAug 2001
- Study completionAug 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies 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 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Robert Maki, MD, PhD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005628
- Sponsor's protocol ID
- 99-077
- Other IDs
- CDR0000067781, NCI-H00-0052
- Status last verified
- Jun 2013
- First submitted
- 2 May 2000
- Last updated
- 19 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Active Specific Immunotherapy in Patients With Recurrent Soft Tissue Sarcoma Using Autologous Tumor-derived Heat Shock Protein-Peptide Complex (HSPPC-96)
- ClinicalTrials.gov ID
- NCT00005628
- Acronym / sponsor ID
- 99-077
- Conditions
- Sarcoma
- Keywords
- recurrent adult soft tissue sarcoma, stage IV adult soft tissue sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 1999
- Primary completion
- Aug 2001 (actual)
- Study completion
- Aug 2001 (actual)
- First posted
- 2 Apr 2004 (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.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have recurrent soft tissue sarcoma.
Detailed description
OBJECTIVES: I. Determine the efficacy of autologous tumor cell-derived heat shock protein peptide vaccine in terms of the rate of complete and partial response and time to progression in patients with recurrent soft tissue sarcoma. II. Determine the safety and tolerability of this treatment regimen in this patient population. III. Determine the anti-tumor response to this treatment regimen in these patients.
OUTLINE: At approximately 5 weeks after surgery, patients receive autologous tumor cell-derived heat shock protein peptide vaccine intradermally weekly for 4 weeks. Patients receive subsequent vaccinations once every 2 weeks for at least 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with improving or stable disease or without recurrence continue on therapy for up to 1 year.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- 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 |
|---|---|---|
| vitespen | Biological | – |
Primary outcome
Not reported in the source record.
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 19 Jun 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.
Robert Maki, 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 2 study testing vitespen in people with Sarcoma, 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 19 Jun 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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 19 Jun 2013.