Ovarian CancerPhase 1NCT00637390
A Phase I Study of Alemtuzumab in Patients With Relapsed Ovarian/Primary Peritoneal Cancer.
A Phase 1 study testing Alemtuzumab in people with Ovarian Cancer and Fallopian Tube Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
Ovarian cancer cannot grow without recruiting new blood vessels. Studies in humans have identified a novel cell population, termed vascular leukocytes (VLCs). While VLCs are not cancer cells, they support the growth of ovarian cancer cells by stimulating the growth of new blood vessels which provide the cancer with… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- What is being tested?
- Alemtuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Oct 2010
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a diagnosis of histologically confirmed ovarian, fallopian or primary peritoneal cancer that has progressed or recurred in the abdomen or pelvis after salvage chemotherapy as documented by either:
- Radiologic studies or
- Rising CA125 levels on two independent measurements. If the patient's CA125 has fallen into a normal range, CA125 relapse will be defined as double the nadir CA125. However, if the patients CA125 nadir had fallen to less than 10, then the measurements documenting recurrence or progression must be greater than 20.
- There is no limit on prior courses of chemotherapy.
- Patients must have unidimensional measurable disease or elevated CA125
- Age greater than 18 years.
Show all 14Show fewer
- ECOG performance status less tha 2 (Karnofsky 60%).
- Life expectancy of greater than 12 weeks.
- Patients must have adequate organ and marrow function
- Ability to understand and the willingness to sign a written informed consent document. All patients must be informed of the investigational nature of this study and must sign an informed consent in accordance with institutional and federal guidelines.
- Timing guideline for pre-study labs and measurements:
- All pre-study labs required for determination of eligibility are to be completed within 28 days of treatment Day 1.
- X-rays and/or scans used for tumor measurement to determine disease status are to be completed within 28 days of treatment Day 1.
- Women of all races and ethnic groups are eligible for this trial.
Who cannot join
- Patients with known immunosuppressive diseases are excluded from this trial due to the known immunosuppressive nature of Alemtuzumab therapy.
- Patients may not be receiving any other agents (investigational or otherwise) with therapeutic intent.
- Patients with prior malignancy, except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for 2 years.
- Patients with a history of allergic reactions to Alemtuzumab or other humanized immunotherapeutics.
- Patients with unresolved bacterial, fungal, or viral infections requiring active treatment. Patients may be registered two weeks after the conclusion of antibiotic or anti-viral therapy.
- Patients with history of active CMV disease as Alemtuzumab therapy has been associated with CMV reactivation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
About this study
Ovarian cancer cannot grow without recruiting new blood vessels. Studies in humans have identified a novel cell population, termed vascular leukocytes (VLCs). While VLCs are not cancer cells, they support the growth of ovarian cancer cells by stimulating the growth of new blood vessels which provide the cancer with nutrients. VLCs make a protein termed CD52. An antibody therapeutic, Alemtuzumab (also know as Campath), that kills cells that make the CD52 protein has been successfully used to treat certain lymphomas (a type of blood cell cancer) that make CD52 protein. The purpose of this study is to determine if Alemtuzumab given subcutaneously (under the skin)can be safely given to patients with ovarian, fallopian, or primary peritoneal cancers to kill VLCs and determine if Alemtuzumab, by eliminating VLCs, can restrict tumor growth or increase response rates to chemotherapy given after the discontinuation of chemotherapy.
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Being tested
- Alemtuzumab
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlemtuzumabDrug
will be given Alemtuzumab therapy three times in your first week on the study and then once a week for six additional weeks
| Study group | Role | What they receive |
|---|---|---|
| one | Experimental | Not described Receives: Drug: Alemtuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety & maximally tolerated dose
Measured: Maybe 2 years
Secondary outcomes (4)
Effectiveness of Alemtuzumab to eliminate VLCs.
Measured: Maybe 2 years
Assess molecular markers associated with reduction in VLCs.
Measured: Maybe 2 years
Anti-tumor activity measured by decline or stabilization of CA125(a protein that is a tumor marker)or radiological(ie. CT, MRI, X-Ray)improvement or improvement in progression free survival.
Measured: Maybe 2 years
Alemtuzumab effect on patients' response rates to chemotherapy given after the discontinuation of chemotherapy.
Measured: Maybe 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: Genzyme will no longer supply the study drug for this trial as it does not believe the study will not fully enroll within an appropriate time frame.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637390
- Sponsor's protocol ID
- UMCC 2007.120
- Status last verified
- Dec 2016
- First submitted
- 10 Mar 2008
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Alemtuzumab in Patients With Relapsed Ovarian/Primary Peritoneal Cancer.
- ClinicalTrials.gov ID
- NCT00637390
- Acronym / sponsor ID
- UMCC 2007.120
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Genzyme will no longer supply the study drug for this trial as it does not believe the study will not fully enroll within an appropriate time frame.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 18 Mar 2008 (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.
Ovarian cancer cannot grow without recruiting new blood vessels. Studies in humans have identified a novel cell population, termed vascular leukocytes (VLCs). While VLCs are not cancer cells, they support the growth of ovarian cancer cells by stimulating the growth of new blood vessels which provide the cancer with nutrients. VLCs make a protein termed CD52. An antibody therapeutic, Alemtuzumab (also know as Campath), that kills cells that make the CD52 protein has been successfully used to treat certain lymphomas (a type of blood cell cancer) that make CD52 protein. The purpose of this study is to determine if Alemtuzumab given subcutaneously (under the skin)can be safely given to patients with ovarian, fallopian, or primary peritoneal cancers to kill VLCs and determine if Alemtuzumab, by eliminating VLCs, can restrict tumor growth or increase response rates to chemotherapy given after the discontinuation of chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one | Experimental | Drug: Alemtuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must have a diagnosis of histologically confirmed ovarian, fallopian or primary peritoneal cancer that has progressed or recurred in the abdomen or pelvis after salvage chemotherapy as documented by either:
- There is no limit on prior courses of chemotherapy.
- Patients must have unidimensional measurable disease or elevated CA125
- Age greater than 18 years.
- ECOG performance status less tha 2 (Karnofsky 60%).
Key exclusion criteria (6 listed)
- Patients with known immunosuppressive diseases are excluded from this trial due to the known immunosuppressive nature of Alemtuzumab therapy.
- Patients may not be receiving any other agents (investigational or otherwise) with therapeutic intent.
- Patients with prior malignancy, except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for 2 years.
- Patients with a history of allergic reactions to Alemtuzumab or other humanized immunotherapeutics.
- Patients with unresolved bacterial, fungal, or viral infections requiring active treatment. Patients may be registered two weeks after the conclusion of antibiotic or anti-viral therapy.
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 |
|---|---|---|
| Alemtuzumabwill be given Alemtuzumab therapy three times in your first week on the study and then once a week for six additional weeks | Drug | one |
Primary outcome
safety & maximally tolerated dose
Time frame: Maybe 2 years
4 secondary outcomes
Effectiveness of Alemtuzumab to eliminate VLCs.
Time frame: Maybe 2 years
Assess molecular markers associated with reduction in VLCs.
Time frame: Maybe 2 years
Anti-tumor activity measured by decline or stabilization of CA125(a protein that is a tumor marker)or radiological(ie. CT, MRI, X-Ray)improvement or improvement in progression free survival.
Time frame: Maybe 2 years
Alemtuzumab effect on patients' response rates to chemotherapy given after the discontinuation of chemotherapy.
Time frame: Maybe 2 years
Results and safety
The study was stopped early (reason given: Genzyme will no longer supply the study drug for this trial as it does not believe the study will not fully enroll within an appropriate time frame.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2016.
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Alemtuzumab in people with Ovarian Cancer and Fallopian Tube Cancer, run by University of Michigan Rogel 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?
The sponsor lists 14 inclusion and 6 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: stopped early, as of the sponsor's last update on 2 Dec 2016. 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 was stopped early (reason given: Genzyme will no longer supply the study drug for this trial as it does not believe the study will not fully enroll within an appropriate time frame.). Results are not available in the source record.
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 & maximally tolerated dose (time frame: Maybe 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 2 Dec 2016.