Stage IA Fallopian Tube CancerPhase 2NCT00857545
OPT-821 With or Without Vaccine Therapy in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in Second or Third Complete Remission
A Phase 2 study testing Laboratory Biomarker Analysis, Polyvalent Antigen-KLH Conjugate Vaccine and Saponin-based Immunoadjuvant OBI-821 in people with Stage IA Fallopian Tube Cancer and Stage IA Ovarian Cancer, run by Gynecologic Oncology Group at 46 sites in United States.
Trial summary
This randomized phase II trial studies OPT-821 and vaccine therapy to see how well they work compared with OPT-821 alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer that has decreased or disappeared, but the cancer may still be in the body. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stage IA Fallopian Tube Cancer, Stage IA Ovarian Cancer, Stage IB Fallopian Tube Cancer
- What is being tested?
- Laboratory Biomarker Analysis, Polyvalent Antigen-KLH Conjugate Vaccine and Saponin-based Immunoadjuvant OBI-821
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 46 sitesUnited States
- Study dates
- Jul 2010to Sep 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically documented epithelial carcinoma arising in the ovary, fallopian tube, or peritoneum, of any stage or grade at diagnosis; all patients must have had cytoreductive surgery and chemotherapy with at least one platinum-based chemotherapy regimen as part of primary treatment
- Patients who recurred on or after initial therapy, and are now in a second or third complete clinical remission and who are within four months of their last treatment are eligible; complete clinical remission is defined as serum cancer antigen (CA)-125 within institutional normal limits, negative physical examination, and no definite evidence of disease by computed tomography (CT) of the abdomen and pelvis; lymph nodes and/or soft tissue abnormalities =< 1.0 cm are often present in the pelvis and will not be considered definite evidence of disease; eligibility is determined by anatomical imaging only (ie. magnetic resonance imaging [MRI] or CT); a positive positron emission tomography (PET) image (if performed) will not exclude a patient if other criteria are met and anatomical imaging is negative
- Absolute neutrophil count (ANC) greater than or equal to 1,000/mm^3, equivalent to Common Toxicity Criteria for Adverse Events (CTCAE version [v]4.0) grade 1
- Platelets greater than or equal to 100,000/mm^3
- Serum creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v4.0 grade 1
- Bilirubin less than or equal to 2.5 x ULN
Show all 11Show fewer
- Serum glutamic oxaloacetic transaminase (SGOT), serum glutamate pyruvate transaminse (SGPT) less than or equal to 2.5 x ULN
- Alkaline phosphatase less than or equal to 2.5 x ULN
- Patients must have a Gynecological Oncology Group (GOG) performance status of 0, 1, or 2
- Patients who have signed the informed consent document and signed the authorization permitting release of personal health information
- Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and must be practicing an effective form of birth control; nursing mothers are excluded
Who cannot join
- With the exception of non-melanoma skin cancer, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy are excluded
- Patients whose circumstances at the time of entry onto the protocol would not permit completion of study or required follow up
- Patients who have an allergy to shellfish
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
United States46 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, 44304
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102
Southwest Gynecologic Oncology Associates Inc
Albuquerque, New Mexico, 87106
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
AnMed Health Cancer Center
Anderson, South Carolina, 29621
Northside Hospital
Atlanta, Georgia, 30342
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
Northwestern University
Chicago, Illinois, 60611
University of Cincinnati
Cincinnati, Ohio, 45267
Case Western Reserve University
Cleveland, Ohio, 44106
Miami Valley Hospital
Dayton, Ohio, 45409
Union Hospital of Cecil County
Elkton, Maryland, 21921
Gynecologic Oncology of West Michigan PLLC
Grand Rapids, Michigan, 49546
Saint Francis Hospital
Greenville, South Carolina, 29601
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, 29605
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, 29615
Saint Vincent Oncology Center
Indianapolis, Indiana, 46260
Kettering Medical Center
Kettering, Ohio, 45429
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89169
Beebe Medical Center
Lewes, Delaware, 19958
Lake University Ireland Cancer Center
Mentor, Ohio, 44060
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Winthrop University Hospital
Mineola, New York, 11501
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, 36688
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
Stanford Cancer Institute
Palo Alto, California, 94304
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
The Women's Institute for Gynecologic Cancer and Special Pelvic Surgery
Phillipsburg, New Jersey, 08865
Women and Infants Hospital
Providence, Rhode Island, 02905
Center of Hope at Renown Medical Center
Reno, Nevada, 89502
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, 24016
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
UCSF Medical Center-Mount Zion
San Francisco, California, 94115
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, 29307
Washington University School of Medicine
St Louis, Missouri, 63110
University of Toledo
Toledo, Ohio, 43614
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
Southeast Clinical Oncology Research (SCOR) Consortium NCORP
Winston-Salem, North Carolina, 27104
About this study
Official title: A Phase II Randomized, Double-Blind Trial of a Polyvalent Vaccine-KLH Conjugate (NSC 748933 ) + OPT-821 Versus OPT-821 in Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Who Are in Second or Third Complete Remission
This randomized phase II trial studies OPT-821 and vaccine therapy to see how well they work compared with OPT-821 alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer that has decreased or disappeared, but the cancer may still be in the body. Biological therapies, such as OPT-821, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines may help the body build an effective immune response to kill tumor cells. It is not yet known whether OPT-821 is more effective with or without vaccine therapy in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine if a polyvalent vaccine (including GM2-keyhole limpet hemocyanin [KLH], Globo-H-KLH, Tn-mucin 1 [MUC1]-32mer-KLH, and Thompson Friedreich antigen [TF]-KLH plus OPT-821) decreases the hazard of progression or death compared to a vaccine containing OPT-821 alone in women with epithelial ovarian, fallopian tube, or peritoneal cancer in second or third complete clinical remission.
SECONDARY OBJECTIVES:
- To compare the treatment arms with respect to the incidence of toxicities. II. To determine if the polyvalent vaccine decreases the hazard of death compared to a vaccine containing OPT-821 alone in women with epithelial ovarian, fallopian tube, or peritoneal cancer in second or third complete clinical remission.
TERTIARY OBJECTIVES:
- To evaluate the immune response (by enzyme linked immunosorbent assay [ELISA]) in participants, in order to determine if the outcome correlates with antigen-specific immune titers.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive polyvalent antigen-KLH conjugate vaccine and immunological adjuvant OPT-821 subcutaneously (SC) once in weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71, and 83 in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive immunological adjuvant OPT-821 SC as in Arm I.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
- Conditions
- Stage IA Fallopian Tube Cancer, Stage IA Ovarian Cancer, Stage IB Fallopian Tube Cancer, Stage IB Ovarian Cancer, Stage IC Fallopian Tube Cancer, Stage IC Ovarian Cancer
- Being tested
- Laboratory Biomarker Analysis, Polyvalent Antigen-KLH Conjugate Vaccine, Saponin-based Immunoadjuvant OBI-821
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
Polyvalent Antigen-KLH Conjugate VaccineBiological
Given SC
Saponin-based Immunoadjuvant OBI-821Biological
Also called OBI-821, OPT-821
Given SC
| Study group | Role | What they receive |
|---|---|---|
| Arm I (vaccine therapy and adjuvant) | Experimental | Patients receive polyvalent antigen-KLH conjugate vaccine and immunological adjuvant OPT-821 subcutaneously (SC) once in weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71, and 83 in the absence of disease progression or unacceptable toxicity. Receives: Other: Laboratory Biomarker Analysis; Biological: Polyvalent Antigen-KLH Conjugate Vaccine; Biological: Saponin-based Immunoadjuvant OBI-821 |
| Arm II (adjuvant) | Experimental | Patients receive immunological adjuvant OPT-821 SC as in arm I. Receives: Other: Laboratory Biomarker Analysis; Biological: Saponin-based Immunoadjuvant OBI-821 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
Progression-free survival is the period of time from the date of randomization to the date of first clinical, biochemical, or radiological evidence of progression, death due to any cause or date of last contact, whichever occurs first. Progression is defined as increasing clinical, radiological or histological evidence of disease. Patients with progressing disease based on clinical or histologic basis (ie. biopsy) must also have CT scan of the abdomen and pelvis performed.
Measured: Every 3 month until 2 years from start of treatment, then every 6 months for 3 years; then annually if patient remains in remission.
Secondary outcomes (2)
Incidence of Adverse Effects (Grade 3 or Higher) During Treatment Period
Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.
Measured: During treatment period and up to 30 days after stopping the study treatment; up to 83 weeks.
Overall Survival
Overall survival is defined as the duration of time from study entry to time of death due to any cause or the date of last contact.
Measured: From study entry to death or last contact, up to 5 years of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startJul 2010
- Primary completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage IA Fallopian Tube CancerStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Paul Sabbatini, Principal investigator, NRG Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857545
- Sponsor's protocol ID
- GOG-0255
- Other IDs
- NCI-2009-01176, CDR0000636384, GOG-0255, GOG-0255, U10CA180868, U10CA027469
- Status last verified
- Dec 2016
- First submitted
- 5 Mar 2009
- Last updated
- 13 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
O'Cearbhaill RE, Deng W, Chen LM, Lucci JA 3rd, Behbakht K, Spirtos NM, Muller CY, Benigno BB, Powell MA, Berry E, Tewari KS, Hanjani P, Lankes HA, Aghajanian C, Sabbatini PJ. A phase II randomized, double-blind trial of a polyvalent Vaccine-KLH conjugate (NSC 748933 IND# 14384) + OPT-821 versus OPT-821 in patients with epithelial ovarian, fallopian tube, or peritoneal cancer who are in second or third complete remission: An NRG Oncology/GOG study. Gynecol Oncol. 2019 Dec;155(3):393-399. doi: 10.1016/j.ygyno.2019.09.015. Epub 2019 Oct 22.
PubMed 31653510
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double-Blind Trial of a Polyvalent Vaccine-KLH Conjugate (NSC 748933 ) + OPT-821 Versus OPT-821 in Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Who Are in Second or Third Complete Remission
- ClinicalTrials.gov ID
- NCT00857545
- Acronym / sponsor ID
- GOG-0255
- Conditions
- Stage IA Fallopian Tube Cancer, Stage IA Ovarian Cancer, Stage IB Fallopian Tube Cancer, Stage IB Ovarian Cancer, Stage IC Fallopian Tube Cancer, Stage IC Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2010
- Primary completion
- Sep 2015 (actual)
- First posted
- 6 Mar 2009 (estimated)
- Results
- Posted 6 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase II trial studies OPT-821 and vaccine therapy to see how well they work compared with OPT-821 alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer that has decreased or disappeared, but the cancer may still be in the body. Biological therapies, such as OPT-821, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines may help the body build an effective immune response to kill tumor cells. It is not yet known whether OPT-821 is more effective with or without vaccine therapy in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine if a polyvalent vaccine (including GM2-keyhole limpet hemocyanin [KLH], Globo-H-KLH, Tn-mucin 1 [MUC1]-32mer-KLH, and Thompson Friedreich antigen [TF]-KLH plus OPT-821) decreases the hazard of progression or death compared to a vaccine containing OPT-821 alone in women with epithelial ovarian, fallopian tube, or peritoneal cancer in second or third complete clinical remission.
SECONDARY OBJECTIVES:
- To compare the treatment arms with respect to the incidence of toxicities. II. To determine if the polyvalent vaccine decreases the hazard of death compared to a vaccine containing OPT-821 alone in women with epithelial ovarian, fallopian tube, or peritoneal cancer in second or third complete clinical remission.
TERTIARY OBJECTIVES:
- To evaluate the immune response (by enzyme linked immunosorbent assay [ELISA]) in participants, in order to determine if the outcome correlates with antigen-specific immune titers.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive polyvalent antigen-KLH conjugate vaccine and immunological adjuvant OPT-821 subcutaneously (SC) once in weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71, and 83 in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive immunological adjuvant OPT-821 SC as in Arm I.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (vaccine therapy and adjuvant) | Experimental | Other: Laboratory Biomarker Analysis, Biological: Polyvalent Antigen-KLH Conjugate Vaccine, Biological: Saponin-based Immunoadjuvant OBI-821Patients receive polyvalent antigen-KLH conjugate vaccine and immunological adjuvant OPT-821 subcutaneously (SC) once in weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71, and 83 in the absence of disease progression or unacceptable toxicity. |
| Arm II (adjuvant) | Experimental | Other: Laboratory Biomarker Analysis, Biological: Saponin-based Immunoadjuvant OBI-821Patients receive immunological adjuvant OPT-821 SC as in arm I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with histologically documented epithelial carcinoma arising in the ovary, fallopian tube, or peritoneum, of any stage or grade at diagnosis; all patients must have had cytoreductive surgery and chemotherapy with at least one platinum-based chemotherapy regimen as part of primary treatment
- Patients who recurred on or after initial therapy, and are now in a second or third complete clinical remission and who are within four months of their last treatment are eligible; complete clinical remission is defined as serum cancer antigen (CA)-125 within institutional normal limits, negative physical examination, and no definite evidence of disease by computed tomography (CT) of the abdomen and pelvis; lymph nodes and/or soft tissue abnormalities =< 1.0 cm are often present in the pelvis and will not be considered definite evidence of disease; eligibility is determined by anatomical imaging only (ie. magnetic resonance imaging [MRI] or CT); a positive positron emission tomography (PET) image (if performed) will not exclude a patient if other criteria are met and anatomical imaging is negative
- Absolute neutrophil count (ANC) greater than or equal to 1,000/mm^3, equivalent to Common Toxicity Criteria for Adverse Events (CTCAE version [v]4.0) grade 1
- Platelets greater than or equal to 100,000/mm^3
- Serum creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v4.0 grade 1
Key exclusion criteria (3 listed)
- With the exception of non-melanoma skin cancer, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy are excluded
- Patients whose circumstances at the time of entry onto the protocol would not permit completion of study or required follow up
- Patients who have an allergy to shellfish
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 |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (vaccine therapy and adjuvant), Arm II (adjuvant) |
| Polyvalent Antigen-KLH Conjugate VaccineGiven SC | Biological | Arm I (vaccine therapy and adjuvant) |
| Saponin-based Immunoadjuvant OBI-821Also: OBI-821, OPT-821Given SC | Biological | Arm I (vaccine therapy and adjuvant), Arm II (adjuvant) |
Primary outcome
Progression-free Survival (PFS)
Time frame: Every 3 month until 2 years from start of treatment, then every 6 months for 3 years; then annually if patient remains in remission.
Progression-free survival is the period of time from the date of randomization to the date of first clinical, biochemical, or radiological evidence of progression, death due to any cause or date of last contact, whichever occurs first. Progression is defined as increasing clinical, radiological or histological evidence of disease. Patients with progressing disease based on clinical or histologic basis (ie. biopsy) must also have CT scan of the abdomen and pelvis performed.
2 secondary outcomes
Incidence of Adverse Effects (Grade 3 or Higher) During Treatment Period
Time frame: During treatment period and up to 30 days after stopping the study treatment; up to 83 weeks.
Overall Survival
Time frame: From study entry to death or last contact, up to 5 years of follow-up.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31653510O'Cearbhaill RE, Deng W, Chen LM, Lucci JA 3rd, Behbakht K, Spirtos NM, Muller CY, Benigno BB, Powell MA, Berry E, Tewari KS, Hanjani P, Lankes HA, Aghajanian C, Sabbatini PJ. A phase II randomized, double-blind trial of a polyvalent Vaccine-KLH conjugate (NSC 748933 IND# 14384) + OPT-821 versus OPT-821 in patients with epithelial ovarian, fallopian tube, or peritoneal cancer who are in second or third complete remission: An NRG Oncology/GOG study. Gynecol Oncol. 2019 Dec;155(3):393-399. doi: 10.1016/j.ygyno.2019.09.015. Epub 2019 Oct 22.
Related trials for Stage IA Fallopian Tube Cancer
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Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer
Borderline Ovarian Mucinous Tumor, Ovarian Mucinous Cystadenocarcinoma
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.
Paul Sabbatini principal investigator
NRG Oncology
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laboratory Biomarker Analysis, Polyvalent Antigen-KLH Conjugate Vaccine and Saponin-based Immunoadjuvant OBI-821 in people with Stage IA Fallopian Tube Cancer and Stage IA Ovarian Cancer, run by Gynecologic Oncology Group at 46 sites 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?
The sponsor lists 11 inclusion and 3 exclusion criteria. 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 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites 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?
Yes. Results are posted in the registry (first posted 6 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression-free Survival (PFS) (time frame: Every 3 month until 2 years from start of treatment, then every 6 months for 3 years; then annually if patient remains in remission.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00857545, which also lists 1 linked publication.
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 13 Sep 2017.