Chemoimmunotherapy Study for Patients With Epithelial Ovarian Cancer
A Phase II Study of Chemoimmunotherapy for Patients With Potentially Platinum Sensitive Müllerian (Epithelial Ovarian, Peritoneal, or Fallopian Tube) Carcinomas
1 other identifier
interventional
59
1 country
1
Brief 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.Determine whether this treatment schedule is associated with:
- 3.increased levels of monocytes (\>2-fold and absolute numbers 1000 cells/ml,) and of LN-DR+ DC (CD11c+ and CD123+ subsets)
- 4.induction of priming and activation of MO/MA (monocytes/ macrophages), and maturation of DC (dendritic cells).
- 5.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.
- 6.Determine the effects of carboplatin plus GM-CSF and rIFN-g on quality of life in patients with platinum-sensitive Müllerian carcinomas.
- 7.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 ovarian-cancer
Started Jan 2003
Longer than P75 for phase_2 ovarian-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 12, 2007
CompletedFirst Posted
Study publicly available on registry
July 16, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedResults Posted
Study results publicly available
January 10, 2011
CompletedAugust 7, 2012
August 1, 2012
6 years
July 12, 2007
December 23, 2010
August 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Follow up CT scans after every 3 courses of treatment and following completion of all treatments.
Study Arms (1)
Chemoimmunotherapy
EXPERIMENTALGM-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
Interventions
AUC of 5 by 1 hour IV infusion every 28 days.
Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy.
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).
Eligibility Criteria
You may qualify if:
- 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)
- 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)
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharmacollaborator
- Bristol-Myers Squibbcollaborator
- InterMunecollaborator
Study Sites (1)
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (2)
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.
PMID: 16603073BACKGROUNDSchmeler 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.
PMID: 19264351RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michael E. Garcia, RN, BSN
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Ralph Freedman, MD, PhD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2007
First Posted
July 16, 2007
Study Start
January 1, 2003
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
August 7, 2012
Results First Posted
January 10, 2011
Record last verified: 2012-08