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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA043703 | U.S. NIH Grant/Contract | View source | |
| CASE-CCF-IRB-5179 | Other Identifier | Internal IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy, such as methotrexate, vinorelbine, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. Cisplatin may also make tumor cells more sensitive to radiation therapy. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy with or without surgery and chemoradiotherapy works in treating patients with malignant pleural mesothelioma.
OBJECTIVES:
Primary
Secondary
OUTLINE:
Quality of life is assessed at baseline, after each course of induction chemotherapy, before surgery, and then every 3 months thereafter.
After completion of study therapy, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction Combination Chemotherapy | Experimental | Induction chemotherapy: Patients get MVP chemo. Treatment repeats every 28 days for 2 courses. Patients w/ unresectable disease may get up to 2 add'l courses of induction chemo. Patients requiring palliative radiotherapy or have PD are removed from study. Patients w/ resectable disease or sarcomatoid histology & T1-3, N1-2 disease w/ a CR or PR to induction chemo go to surgery. Surgery: Patients w/ extensive disease get palliative debulking pleurectomy and decortication & are taken off study. Other patients undergo a thoracotomy w/ extrapleural pneumonectomy & proceed to chemoradiotherapy. Chemoradiotherapy: At 6-10 weeks post-op, patients get 3-dimensional conformal or intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks. Patients receive cisplatin IV over 30-60 minutes days 1 & 22. Patients w/ responding disease proceed to adjuvant chemotherapy. Adjuvant chemotherapy: Patients get 2 more courses of MVP chemotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug |
| ||
| Methotrexate |
| Measure | Description | Time Frame |
|---|---|---|
| Best Response | Best response to chemotherapy after induction | After 2-4 cycles of induction chemotherapy (28 day cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability and toxicity | Toxicity related to induction chemotherapy | After 2-4 cycles of induction chemotherapy (28 day cycle) |
| Relapse free and overall survival | Time to relapse and overall survival |
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DISEASE CHARACTERISTICS:
Histologically confirmed malignant pleural mesothelioma
Amenable to aggressive surgical resection, if deemed resectable
Patients with potentially resectable disease must have undergone mediastinoscopy to establish surgical stage
Resectable disease is defined as any of the following:
Intraperitoneal extension, contralateral thoracic extension, or distant metastases are eligible, but considered unresectable
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| David J. Adelstein, MD | Case Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
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|
| Vinorelbine ditartrate | Drug |
|
| Adjuvant therapy | Procedure |
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| Conventional surgery | Procedure |
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| Neoadjuvant Therapy | Procedure |
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| 3-dimensional conformal radiation therapy | Radiation |
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| Intensity-modulated radiation therapy | Radiation |
|
| From date of randomization until the date of first documented progression or date of death from any cause, whichever came first |
| Assess Patient Quality of Life | Patient Quality of Life during induction chemotherapy | Prior to initiation of each cycle of therapy, and every 3 months after completion of therapy until death, withdrawal or loss to follow up (Average 10 years) |
| ID | Term |
|---|---|
| D000086002 | Mesothelioma, Malignant |
| D054363 | Solitary Fibrous Tumor, Pleural |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D054364 | Solitary Fibrous Tumors |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D008727 | Methotrexate |
| D000077235 | Vinorelbine |
| D017024 | Chemotherapy, Adjuvant |
| D020360 | Neoadjuvant Therapy |
| D020266 | Radiotherapy, Conformal |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
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