Adjuvant Radiation Therapy With Ifosfamide in Patients With Mixed Mesodermal Tumors of the Uterus

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The optimal sequence and /or modality for adjuvant therapy in the management of Mixed Mesodermal Tumors (MMT) clearly remains to be established. The rationale for the protocol is to "sandwich" pelvic radiation with chemotherapy to decrease distant metastasis.

The proposed study will sandwich radiation between the two most active chemotherapeutic agents for MMT identified to date (ifosfamide/cisplatin). By doing so, we attempt to decrease both local and distant recurrence, which may translate into an improved progression free interval and possibly even extend survival.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Montefiore Medical Center
• Treatments: Ifosfamide; Isophosphamide mustard

Criteria

Inclusion Criteria:

• Histologically documented mixed mesodermal tumor (MMT) of uterus with no visible residual disease.

• Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node sampling.

• Surgical staging should be completed 6 weeks ± 7 days prior to enrollment.

• Age >= 18 years.

• Written voluntary informed consent.

Exclusion Criteria:

• Patient has impairment of hepatic, renal or hematologic function as defined by the following baseline laboratory values:

• Total serum bilirubin >1.5mg/dl

• History of chronic or active hepatitis

• Serum creatinine >2.0 mg/dl

• Platelets <100,000/mm3

• Absolute neutrophil count (ANC) <1500/mm3

• Hemoglobin <8.0 g/dl (the patient may be transfused prior to study entry)

• Patient has severe or uncontrolled medical disease (eg. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)

• Patient has been treated with myelosuppressive chemotherapy within three weeks prior to study entry.

• Patients with any prior chemotherapy or radiotherapy for pelvic malignancy.

• Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at time of study entry.

• Patient has a uterine sarcoma other then mixed mesodermal tumor (MMT).