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Trial record 15 of 430 for:    ifosfamide

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

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ClinicalTrials.gov Identifier: NCT00231842
Recruitment Status : Completed
First Posted : October 4, 2005
Results First Posted : January 23, 2019
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Mark H. Einstein, Montefiore Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Uterine Cancer Drug: Ifosfamide Device: Radiation Therapy Drug: Cisplatin Phase 2

Detailed Description:

Uterine sarcomas account for only 2-4% of uterine malignancies, yet they are responsible for 26% of uterine cancer deaths. Mixed mesodermal tumors (MMT), previously known as carcinosarcoma, are the most common of the uterine sarcomas in the United States. Prognosis for these patients is generally grim due to the propensity for early metastatic disease. Patterns of spread are by both hematogenous and lymphatic dissemination. It has been noted that 66% of patients with disease clinically confined to the uterus have nodal metastasis at the time of diagnosis. The majority of patients will die with both wide spread intra-abdominal and pelvic disease within two years of diagnosis.

Adjuvant pelvic radiation therapy has been advantageous in controlling local recurrence. One study reports 26% local recurrence in patients treated with surgery alone versus 14% recurrence in patients treated with surgery and adjuvant pelvic radiation. Although adjuvant radiation shows a benefit in improving local control, it has not been found to impact survival. This finding is likely attributed to the high incidence of distant metastasis (85%) known to occur with disease recurrence.

Multiple chemotherapeutic agents have been evaluated in the management of advanced, persistent or recurrent uterine MMT. Response to single agent therapy has been less than 35% with the most active agents identified being ifosfamide (response rate = 34.8%) and cisplatin (response rate 17.9%. The use of chemotherapy in the adjuvant setting has been explored as a means of attempting to impact the incidence of distant metastasis.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Phase II Trial of Adjuvant Radiation Therapy "Sandwiched" Between Ifosfamide in Patients With Mixed Mesodermal Tumors
Actual Study Start Date : February 2003
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011


Arm Intervention/treatment
Experimental: Ifosfamide with or without cisplatin
Participants with surgically staged carcinosarcoma (CS) with no gross residual disease were initially administered ifosfamide (1.2 g/m2/day for 5 days) with cisplatin (20 mg/m2/day for 5 days) every 3 weeks for 3 cycles followed by pelvic external beam RT and brachytherapy followed by 3 additional cycles of ifosfamide (1.0 g/m2/day) with cisplatin with cisplatin (20 mg/m2/day for 5 days) evrey 3 weeks. cisplatin added toxicity without additional efficacy, so mid-study, cisplatin was eliminated.
Drug: Ifosfamide
Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IV bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L / day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333 mg/IV bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L /day x 5 days. Repeat q21 days x 3 cycles.

Device: Radiation Therapy
Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IV bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L / day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333 mg /IV bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L /day x 5 days. Repeat q21 days x 3 cycles.
Other Name: Pelvic RT, Radiation

Drug: Cisplatin
dosage is 20 mg/m2/day for 5 days, ever 3 weeks.




Primary Outcome Measures :
  1. Cycles With Hematologic Toxicities [ Time Frame: 2 years ]
    Out of 162 planned cycles, a total of 138 cycles (85%) were administered. Number of cycles during which participants with grades 3 and 4 experienced hematologic toxicities are reported. Most of the toxicities were self-limiting.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00231842


Locations
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Mark H Einstein, M.D., M.S. Montefiore Medical Center and Albert Einstein College of Medicine

Publications of Results:
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Responsible Party: Mark H. Einstein, Director, Clinical Research for Women's Health, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00231842     History of Changes
Other Study ID Numbers: 03-02-040
First Posted: October 4, 2005    Key Record Dates
Results First Posted: January 23, 2019
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Mark H. Einstein, Montefiore Medical Center:
Mixed Mesodermal Tumor
MMT
Uterine Cancer
Radiation Therapy
Chemotherapy

Additional relevant MeSH terms:
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Ifosfamide
Isophosphamide mustard
Uterine Neoplasms
Mixed Tumor, Mesodermal
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Cisplatin
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action