Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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: 1. increased levels of monocytes (\>2-fold and absolute numbers 1000 cells/ml,) and of LN-DR+ DC (CD11c+ and CD123+ subsets) 2. induction of priming and activation of MO/MA (monocytes/ macrophages), and maturation of DC (dendritic cells). 3. 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. 4. Determine the effects of carboplatin plus GM-CSF and rIFN-g on quality of life in patients with platinum-sensitive Müllerian carcinomas. 5. 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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| GM-CSF (Sargramostim) | Drug | — | UNRESOLVED |
| Interferon Gamma | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemoimmunotherapy
- description
- 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
- interventionNames
- Drug: Carboplatin
- Drug: GM-CSF (Sargramostim)
- Drug: Interferon Gamma
Primary outcomes (1)
- measure
- Number of Patients With Response
- timeFrame
- Follow up CT scans after every 3 courses of treatment and following completion of all treatments.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. Measurable disease by radiological or clinical examination parameters. 3. No prior immunotherapy. 4. No concurrent steroids or radiation therapy. 5. Adequate hematological parameters (ANC \>/= 1500 cells/UL, platelets \>/= 100,000 cells/UL 6. Adequate renal function (serum creatinine \</= 1.5 mg/dl) 7. Adequate hepatic function (serum bilirubin \</= 1.5 mg/dl) 8. SGOT or SGPT \</= 2.5 normal 9. Zubrod status \</= 2 10. Signed informed consent 11. Patients with no more than 2 prior therapy regimens (1st line platinum and platinum reinduction will count as one) Exclusion Criteria: 1. Pregnant or lactating women 2. Patients with brain metastases 3. Serum albumin \<3 gm/dl 4. Weight loss \>10% over 4 months 5. Radiation therapy to whole abdomen 6. History of clinical or EKG findings suggestive of active (within the last 6 months) heart disease 7. Patients with active autoimmune or inflammatory bowel disease 8. Patients with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment. 9. Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent. 10. Patients with prior hypersensitivity to platinum agents 11. 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.
References
Publications (2)
- BACKGROUNDApte 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 16603073
- RESULTSchmeler 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 19264351