Ovarian CancerPhase 2NCT00501644
Chemoimmunotherapy Study for Patients With Epithelial Ovarian Cancer
A Phase 2 study testing Carboplatin, GM-CSF (Sargramostim) and Interferon Gamma in people with Ovarian Cancer and Fallopian Tube Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: 1. Determine response rate, time to progression, and toxicity of a schedule of carboplatin by IV (intravenous) infusion, GM-CSF and rIFN-g by SC (subcutaneous injection) in patients with potentially platinum-sensitive recurrent Müllerian carcinomas. 2. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- What is being tested?
- Carboplatin, GM-CSF (Sargramostim) and Interferon Gamma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Jan 2009
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with Müllerian carcinomas (primary epithelial ovarian, primary peritoneal, or fallopian tube) who have had a response to platinum-based chemotherapy and have a chemotherapy treatment-free interval of at least 6 months. These patients are designated potentially platinum-sensitive.
- Measurable disease by radiological or clinical examination parameters.
- No prior immunotherapy.
- No concurrent steroids or radiation therapy.
- Adequate hematological parameters (ANC >/= 1500 cells/UL, platelets >/= 100,000 cells/UL
- Adequate renal function (serum creatinine </= 1.5 mg/dl)
Show all 11Show fewer
- Adequate hepatic function (serum bilirubin </= 1.5 mg/dl)
- SGOT or SGPT </= 2.5 normal
- Zubrod status </= 2
- Signed informed consent
- Patients with no more than 2 prior therapy regimens (1st line platinum and platinum reinduction will count as one)
Who cannot join
- Pregnant or lactating women
- Patients with brain metastases
- Serum albumin <3 gm/dl
- Weight loss >10% over 4 months
- Radiation therapy to whole abdomen
- History of clinical or EKG findings suggestive of active (within the last 6 months) heart disease
Show all 11Show fewer
- Patients with active autoimmune or inflammatory bowel disease
- Patients with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment.
- Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.
- Patients with prior hypersensitivity to platinum agents
- Patients with history of other malignancy, with the exception of non-melanomatous skin cancer; unless in complete remission and off therapy for a minimum of 5 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase II Study of Chemoimmunotherapy for Patients With Potentially Platinum Sensitive Müllerian (Epithelial Ovarian, Peritoneal, or Fallopian Tube) Carcinomas
Primary Objectives:
- Determine response rate, time to progression, and toxicity of a schedule of carboplatin by IV (intravenous) infusion, GM-CSF and rIFN-g by SC (subcutaneous injection) in patients with potentially platinum-sensitive recurrent Müllerian carcinomas.
- Determine whether this treatment schedule is associated with:
- increased levels of monocytes (>2-fold and absolute numbers 1000 cells/ml,) and of LN-DR+ DC (CD11c+ and CD123+ subsets)
- induction of priming and activation of MO/MA (monocytes/ macrophages), and maturation of DC (dendritic cells).
- Determine the toxicity profile of consolidation treatment with IP (intraperitoneal) injections of rIFN-g added to carboplatin (IV) and GM-CSF (SC) for 4 doses/course.
- Determine the effects of carboplatin plus GM-CSF and rIFN-g on quality of life in patients with platinum-sensitive Müllerian carcinomas.
- To begin an exploration of cell surface proteins on purified activated peripheral blood and ascites monocyte/macrophages both before and after treatment with GM-CSFand rIFN-g.
Read the detailed description
Carboplatin is a chemotherapy drug that is used for the treatment of ovarian cancer. GM-CSF is a protein that is used to increase the production of white blood cells. rIFN-g is a protein that stimulates cells of the immune system.
Participants will need to have pre-study blood work (about 4 teaspoons) as part of their evaluation for study entry. In addition, a chest x-ray and CT scan of the abdomen and pelvis will need to be done before any treatments.
Participants in this study will receive a frequently used dose of carboplatin by vein over 1 hour every 28 days. In addition, GM-CSF will be given for 7 days and rIFN-g will be given for 2 days before and after chemotherapy. Both drugs will be given as injections under the skin. They will be repeated with each chemotherapy course that participants receive.
GM-CSF and rIFN-g are being used to try to stimulate the immune system in the belief that this adds to the effectiveness of the chemotherapy on the tumor. During each course of chemotherapy treatment, blood samples will be taken in order to evaluate the blood count response to GM-CSF. Participants will need to remain in the Houston area beginning with the first injection of GM-CSF and for up to 9 days following the carboplatin infusion for the first course.
QOL forms will be completed at 5 separate time points during the first course of chemotherapy. Later courses will only have 2 time points for completion of the QOL forms. The completion of these forms will help researchers to evaluate the effects of the carboplatin and the 2 proteins on participants and their quality of life.
Participants will receive 3 courses of treatment (each course will include 1 treatment with carboplatin followed by 2 separate treatment cycles with GM-CSF and rIFN-g) and then be evaluated for tumor response. If the tumor is responding, 3 additional courses will be given. If after 6 courses of treatment, the tumor has completely responded and there is no evidence of the disease, then up to 4 additional courses can be given for completion of therapy. If the tumor is still responding after 6 courses but has not completely gone away, then additional courses can be given as long as the tumor is responding before completion therapy can be considered.
Completion therapy will include carboplatin given every 28 days by vein along with injections of GM-CSF under the skin before and after the chemotherapy. Injections of rIFN-g will be given directly into the abdomen through an abdominal catheter if possible. If this is not possible, then the rIFN-g will be given as injections under the skin. Participants may choose not to receive the rIFN-g through a catheter during the completion phase and can continue to receive it under the skin with the chemotherapy. A maximum of 4 additional courses can be given during this phase of the study.
Participants whose disease gets worse will be taken off the study. Participants who have intolerable side effect from the study drugs will also be taken off the study treatment. Participants will have follow up CT scans after every 3 courses of treatment. Following completion of all treatments, participants will need to return to M. D. Anderson every 3 months for follow-up exams. This will include a physical exam, blood work, and a CT scan.
This is an investigational study. A total of 65 patients will take part in this study.
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Being tested
- Carboplatin, GM-CSF (Sargramostim), Interferon Gamma
- Keywords
- Müllerian Carcinomas, Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Epithelial Ovarian, Peritoneal, Fallopian Tube, Chemoimmunotherapy, Platinum Sensitive Müllerian, Carboplatin, Paraplatin, GM-CSF, Sargramostim, Interferon Gamma, Quality of Life, QOL
- 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.
CarboplatinDrug
Also called Paraplatin
AUC of 5 by 1 hour IV infusion every 28 days.
GM-CSF (Sargramostim)Drug
Also called Sargramostim
Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy.
Interferon GammaDrug
Also called rIFN-g
0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle).
| Study group | Role | What they receive |
|---|---|---|
| Chemoimmunotherapy | Experimental | GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days Receives: Drug: Carboplatin; Drug: GM-CSF (Sargramostim); Drug: Interferon Gamma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Response
Per World Health Organization (WHO) Tumor Response: Complete Response (CR), Partial Response (PR) or Progressive Disease (PD). CR defined as disappearance of all target lesions, PR as > = 30% decrease in sum of longest dimensions of target lesions with reference baseline sum longest dimensions and if CA 125 levels declined by >50%, provided target lesion size did not increase by >20% on imaging, and PD as >20% increase in sum of longest dimensions of target lesions taking as references smallest sum of longest dimensions recorded since treatment started, or appearance of 1 or > new lesions.
Measured: Follow up CT scans after every 3 courses of treatment and following completion of all treatments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study startJan 2003
- Primary completionJan 2009
- Study completionJan 2009
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 (2)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma, Bristol-Myers Squibb, InterMune
- Responsible party
- Sponsor
- Investigators
- Ralph Freedman, MD, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501644
- Sponsor's protocol ID
- ID02-231
- Status last verified
- Aug 2012
- First submitted
- 12 Jul 2007
- Last updated
- 7 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Apte SM, Vadhan-Raj S, Cohen L, Bassett RL, Gordon IO, Levenback CF, Ramirez PT, Gallardo ST, Patenia RS, Garcia ME, Iyer RB, Freedman RS. Cytokines, GM-CSF and IFNgamma administered by priming and post-chemotherapy cycling in recurrent ovarian cancer patients receiving carboplatin. J Transl Med. 2006 Apr 7;4:16. doi: 10.1186/1479-5876-4-16.
PubMed 16603073Schmeler KM, Vadhan-Raj S, Ramirez PT, Apte SM, Cohen L, Bassett RL, Iyer RB, Wolf JK, Levenback CL, Gershenson DM, Freedman RS. A phase II study of GM-CSF and rIFN-gamma1b plus carboplatin for the treatment of recurrent, platinum-sensitive ovarian, fallopian tube and primary peritoneal cancer. Gynecol Oncol. 2009 May;113(2):210-5. doi: 10.1016/j.ygyno.2009.02.007. Epub 2009 Mar 4.
PubMed 19264351
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Chemoimmunotherapy for Patients With Potentially Platinum Sensitive Müllerian (Epithelial Ovarian, Peritoneal, or Fallopian Tube) Carcinomas
- ClinicalTrials.gov ID
- NCT00501644
- Acronym / sponsor ID
- ID02-231
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Keywords
- Müllerian Carcinomas, Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Epithelial Ovarian, Peritoneal, Fallopian Tube, Chemoimmunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma, Bristol-Myers Squibb, InterMune
- Study start
- Jan 2003
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 16 Jul 2007 (estimated)
- Results
- Posted 10 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives:
- Determine response rate, time to progression, and toxicity of a schedule of carboplatin by IV (intravenous) infusion, GM-CSF and rIFN-g by SC (subcutaneous injection) in patients with potentially platinum-sensitive recurrent Müllerian carcinomas.
- Determine whether this treatment schedule is associated with:
- increased levels of monocytes (>2-fold and absolute numbers 1000 cells/ml,) and of LN-DR+ DC (CD11c+ and CD123+ subsets)
- induction of priming and activation of MO/MA (monocytes/ macrophages), and maturation of DC (dendritic cells).
- Determine the toxicity profile of consolidation treatment with IP (intraperitoneal) injections of rIFN-g added to carboplatin (IV) and GM-CSF (SC) for 4 doses/course.
- Determine the effects of carboplatin plus GM-CSF and rIFN-g on quality of life in patients with platinum-sensitive Müllerian carcinomas.
- To begin an exploration of cell surface proteins on purified activated peripheral blood and ascites monocyte/macrophages both before and after treatment with GM-CSFand rIFN-g.
Detailed description
Carboplatin is a chemotherapy drug that is used for the treatment of ovarian cancer. GM-CSF is a protein that is used to increase the production of white blood cells. rIFN-g is a protein that stimulates cells of the immune system.
Participants will need to have pre-study blood work (about 4 teaspoons) as part of their evaluation for study entry. In addition, a chest x-ray and CT scan of the abdomen and pelvis will need to be done before any treatments.
Participants in this study will receive a frequently used dose of carboplatin by vein over 1 hour every 28 days. In addition, GM-CSF will be given for 7 days and rIFN-g will be given for 2 days before and after chemotherapy. Both drugs will be given as injections under the skin. They will be repeated with each chemotherapy course that participants receive.
GM-CSF and rIFN-g are being used to try to stimulate the immune system in the belief that this adds to the effectiveness of the chemotherapy on the tumor. During each course of chemotherapy treatment, blood samples will be taken in order to evaluate the blood count response to GM-CSF. Participants will need to remain in the Houston area beginning with the first injection of GM-CSF and for up to 9 days following the carboplatin infusion for the first course.
QOL forms will be completed at 5 separate time points during the first course of chemotherapy. Later courses will only have 2 time points for completion of the QOL forms. The completion of these forms will help researchers to evaluate the effects of the carboplatin and the 2 proteins on participants and their quality of life.
Participants will receive 3 courses of treatment (each course will include 1 treatment with carboplatin followed by 2 separate treatment cycles with GM-CSF and rIFN-g) and then be evaluated for tumor response. If the tumor is responding, 3 additional courses will be given. If after 6 courses of treatment, the tumor has completely responded and there is no evidence of the disease, then up to 4 additional courses can be given for completion of therapy. If the tumor is still responding after 6 courses but has not completely gone away, then additional courses can be given as long as the tumor is responding before completion therapy can be considered.
Completion therapy will include carboplatin given every 28 days by vein along with injections of GM-CSF under the skin before and after the chemotherapy. Injections of rIFN-g will be given directly into the abdomen through an abdominal catheter if possible. If this is not possible, then the rIFN-g will be given as injections under the skin. Participants may choose not to receive the rIFN-g through a catheter during the completion phase and can continue to receive it under the skin with the chemotherapy. A maximum of 4 additional courses can be given during this phase of the study.
Participants whose disease gets worse will be taken off the study. Participants who have intolerable side effect from the study drugs will also be taken off the study treatment. Participants will have follow up CT scans after every 3 courses of treatment. Following completion of all treatments, participants will need to return to M. D. Anderson every 3 months for follow-up exams. This will include a physical exam, blood work, and a CT scan.
This is an investigational study. A total of 65 patients will take part in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemoimmunotherapy | Experimental | Drug: Carboplatin, Drug: GM-CSF (Sargramostim), Drug: Interferon GammaGM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with Müllerian carcinomas (primary epithelial ovarian, primary peritoneal, or fallopian tube) who have had a response to platinum-based chemotherapy and have a chemotherapy treatment-free interval of at least 6 months. These patients are designated potentially platinum-sensitive.
- Measurable disease by radiological or clinical examination parameters.
- No prior immunotherapy.
- No concurrent steroids or radiation therapy.
- Adequate hematological parameters (ANC >/= 1500 cells/UL, platelets >/= 100,000 cells/UL
Key exclusion criteria (11 listed)
- Pregnant or lactating women
- Patients with brain metastases
- Serum albumin <3 gm/dl
- Weight loss >10% over 4 months
- Radiation therapy to whole abdomen
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 |
|---|---|---|
| CarboplatinAlso: ParaplatinAUC of 5 by 1 hour IV infusion every 28 days. | Drug | Chemoimmunotherapy |
| GM-CSF (Sargramostim)Also: SargramostimStarting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy. | Drug | Chemoimmunotherapy |
| Interferon GammaAlso: rIFN-g0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle). | Drug | Chemoimmunotherapy |
Primary outcome
Number of Patients With Response
Time frame: Follow up CT scans after every 3 courses of treatment and following completion of all treatments.
Per World Health Organization (WHO) Tumor Response: Complete Response (CR), Partial Response (PR) or Progressive Disease (PD). CR defined as disappearance of all target lesions, PR as > = 30% decrease in sum of longest dimensions of target lesions with reference baseline sum longest dimensions and if CA 125 levels declined by >50%, provided target lesion size did not increase by >20% on imaging, and PD as >20% increase in sum of longest dimensions of target lesions taking as references smallest sum of longest dimensions recorded since treatment started, or appearance of 1 or > new lesions.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16603073Apte SM, Vadhan-Raj S, Cohen L, Bassett RL, Gordon IO, Levenback CF, Ramirez PT, Gallardo ST, Patenia RS, Garcia ME, Iyer RB, Freedman RS. Cytokines, GM-CSF and IFNgamma administered by priming and post-chemotherapy cycling in recurrent ovarian cancer patients receiving carboplatin. J Transl Med. 2006 Apr 7;4:16. doi: 10.1186/1479-5876-4-16.
- Results publication: PubMed 19264351Schmeler KM, Vadhan-Raj S, Ramirez PT, Apte SM, Cohen L, Bassett RL, Iyer RB, Wolf JK, Levenback CL, Gershenson DM, Freedman RS. A phase II study of GM-CSF and rIFN-gamma1b plus carboplatin for the treatment of recurrent, platinum-sensitive ovarian, fallopian tube and primary peritoneal cancer. Gynecol Oncol. 2009 May;113(2):210-5. doi: 10.1016/j.ygyno.2009.02.007. Epub 2009 Mar 4.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Ralph Freedman, MD, PhD principal investigator
M.D. Anderson 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 Carboplatin, GM-CSF (Sargramostim) and Interferon Gamma in people with Ovarian Cancer and Fallopian Tube Cancer, run by M.D. Anderson 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 11 inclusion and 11 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 7 Aug 2012. 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?
Yes. Results are posted in the registry (first posted 10 Jan 2011). 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?
Number of Patients With Response (time frame: Follow up CT scans after every 3 courses of treatment and following completion of all treatments.). 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 NCT00501644, which also lists 2 linked publications.
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 7 Aug 2012.