Trimodal Lung-Sparing Treatment of Pleural Mesothelioma

NCT00859495 | Terminated Phase 2 Results DMC

• 1 other identifier: AAAB9658
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to determine the feasibility (as determined by lack of serious adverse events) and tolerability (as determined by patient's ability to complete the study) of a multimodal lung sparing regimen of surgery, interpleural and intravenous chemotherapy, and local P-32 irradiation for malignant pleural mesothelioma.

Conditions

Pleural Mesothelioma

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Who Were Able to Complete Trimodal Therapy (Combination of Surgery, Intrapleural and Systemic Chemotherapy and P-32 Radiotherapy).

  To determine the feasibility of multimodal lung sparing regimen. Intrapleural chemotherapy (12 weeks) will be administered within two weeks after surgery. Approximately 30 days post last dose of chemotherapy (+/- 14 days), the patient should be reassessed for resolution of any treatment-related toxicity which may have occurred during the course of study participation.

  20 weeks

Study Arms (1)

Multimodal lung sparing regimen

EXPERIMENTAL

Intrapleural chemotherapy plus systemic chemotherapy: Thoracoscopy to implant two intrapleural catheters followed by intrapleural chemotherapy with doxorubicin and cisplatin (weeks 1, 2, 4, 5, 7, and 8). Systemic chemotherapy treatments with cisplatin and pemetrexed during weeks 3, 6, and 9. Intrapleural radiotherapy with P-32 will be given 3 weeks after last dose of chemotherapy and 11 to 12 weeks after initial thoracoscopy.

Drug: Doxorubicin; Drug: Cisplatin; Drug: Pemetrexed; Radiation: Radiotherapy

Interventions

Doxorubicin DRUG

A medication used in cancer chemotherapy, derived by chemical semisynthesis from a bacterial species.

Also known as: Doxil

Multimodal lung sparing regimen

Cisplatin DRUG

Platinum-based antineoplastic

Also known as: Cisplatinum, Platinol

Multimodal lung sparing regimen

Pemetrexed DRUG

Folate Analog Metabolic Inhibitor

Also known as: Alimta

Multimodal lung sparing regimen

Radiotherapy RADIATION

Standard procedure given 3 weeks after last dose of chemotherapy

Also known as: Intrapleural radiotherapy with P-32

Multimodal lung sparing regimen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed malignant mesothelioma, \< 20% sarcomatoid type
• No radiographic or other imaging evidence of Stage IV (cardiac, mediastinal, peritoneal, other distant) disease.
• Ineligible for other high priority national or institutional study.
• Age \>18 years \[to physiologic 75 years\].
• Life expectancy \> 3 months.
• Performance status, PS 0-2 \[Karnofsky Performance Status, KPS=70-100 %\].
• Prior therapy allowed (one prior systemic regimen) meeting the following parameters.
• No prior chest radiation therapy within 6 weeks of treatment
• No prior chemotherapy regimens within four weeks of treatment
• Non pregnant, non-lactating. (serum HCG test will be performed in patients in whom there is a possibility of pregnancy.)
• Required initial laboratory data/clinical parameters (see also Sec. 8.0) White cell count: \>3000/ul. Platelet count: \>100,000/ul. Creatinine clearance: ≥ 45 ml/min Bilirubin: \< 2 x ULN SGOT or SGPT: \< 2 x ULN
• Informed Consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts.
• No other coexistent malignancy. However, curatively treated or fully controlled solid tumors (other than mesothelioma) may be eligible if in the judgement of the PI, the benefit of treatment outweighs the risk.
• No serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g., serious infection, congestive heart failure, angina pectoris, cardiac arrhythmia(s), or uncontrolled hypertension). HIV status or other severe illnesses will be assessed using medical records.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Doxorubicin; liposomal doxorubicin; Cisplatin; Pemetrexed; Radiotherapy; ING2 protein, human

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Therapeutics

Limitations and Caveats

Study was terminated early due to the retirement of the study physician responsible for the P-32 radiotherapy, and the need for further funding.

Results Point of Contact

• Title: Robert Taub, MD
• Organization: Columbia University

rntaubipod@gmail.com

Study Officials

• Robert N Taub, MD, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2009
• First Posted: March 11, 2009
• Study Start: February 1, 2008
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: August 25, 2020
• Results First Posted: August 25, 2020

Record last verified: 2020-08

Locations

US (1)