Clinical trials are research studies into different treatment methods and medications used to treat disease. A clinical trial is typically conducted after extensive research has been performed regarding a medication or treatment protocol. The purpose of the trial is to find out whether a particular treatment or combinations of treatments have a desired effect. Clinical trials are a useful research tool, for they help doctors find a better way to treat, and hopefully cure, diseases such as cancer.

Before participating in a clinical trial, it is important that you learn all of the potential risks and benefits involved. You should consult with your doctor to determine if the trial is right for you. Not every patient can or should participate in a clinical trial. You should seek out as much information as possible before making a decision about participation in a clinical trial.

Clinical trials are usually separated into three phases: Phase I, Phase II and Phase III.

Phase I trials typically involve a small number of patients, and the goal of the trial is usually to determine how best to administer a new treatment or medication, and in what dose.

Phase II trials are held to evaluate the effectiveness of a particular treatment. An important part of phase II trials is the determination of whether the treatment is safe, and what side affects, if any, might be encountered. A larger number of people are usually involved in phase II trials.

Phase III trials continue the work of phase II trials, but place more of a focus on comparing the treatment with existing treatments already in use. A large number of participants are typically involved, and are separated into two or more groups, with each group being given a different treatment. In this way, doctors are able to determine if a new treatment shows any promising advantages over existing treatments.

MAG has compiled a list of some of the protocols available that may be of interest to those persons suffering from mesothelioma. This list is by no means exclusive, so we encourage patients to check with their doctors to see what other trials or protocols are being conducted.

5500 - Phase I/II Trial of a Live, Genetically Modified Salmonella Typhimurium (VNP20009) Administered by Intrapleural Infusion for the Treatment of Unresectable Malignant Intrapleural Mesothelioma

Therapy: Please contact Daniel Sterman for details regarding therapy.

Eligibility*: Please contact Daniel Sterman to discuss eligibility requirements for this trial.

Daniel Sterman, M.D.

(215) 614-0984

UPDATE !! UPCC 5597 - Trial of E1/E4-Deleted Ad.RSVtk Virus With Ganciclovir in Patients With Unresectable Malignant Mesothelioma

Ad. RSVtk + Ganciclovir

• Patients must have malignant mesothelioma of pleural origin.
• May not have undergone successful pleurodesis.
• Prior chemotherapy or radiationis allowed if completed at least 60 days from entry into study.

Adri Recio, RN Daniel Sterman, M.D.

(215) 662-6392 (215) 614-0984

UPCC 15997 - Trial of Photodynamic Therapy with Foscan in Patients with Malignant Pleural Mesothelioma

**only available at the University of Pennsylvania XRT

Photofrin: surgery + PDT

• Histologic diagnosis of malignant pleural mesothelioma that can be resected to a maximal thickness of less than 5 mm.
• Must have disease limited to the hemithorax.
• All cell types of mesothelioma are permitted.

Debbie Smith, RN Stephen Hahn, MD

(215) 662-6694 (215) 662-7269

UPCC 5598 - Gene Therapy of Malignant Mesothelioma Using E1/E4-Deleted Adenoviruses Containing the Herpes Simplex Thymidine Kinase: A Phase I Trial with Dose-Escalation of Intravenous Ganciclovir

E1/E4-Deleted Adenoviruses Containing the Herpes Simplex Thymidine Kinase

• Must have histologically proven malignant mesothelioma of pleural origin

Adri Recio, RN Daniel Sterman, MD

(215) 662-6392 (215) 614-0984

UPDATE!! ECOG E1797) - Trial of Gemcitabine-HCL in Advanced Sarcomas

**Suspended to patient accrual 5/5/99

Gemcitabine-HCL

• Must have hisologically confirmed soft tissue sarcoma.
• For metastatic disease no prior chemotherapy is allowed although one prior biologic regimen is allowed.
• Measurable residual, recurrent or metastatic disease by physical exam

Adri Recio, RN Jane Alavi, MD

(215) 662-6392 (215) 662-6319

UPCC 2598 - Multicenter Randomized Comparative Trial of Onconase + Doxorubicin vs. Doxorubicin in Patients with Malignant Mesothelioma

Therapy:

Onconase or Doxorubicin

Eligibility*:

• Must be at least 21 years old with histologic diagnosis of malignant mesothelioma. Measurable/evaluable disease.

• Must be chemotherapy-naive or have received only 1 prior systemic regimen without Doxorubicin.

Millie Capparro, RN Kenneth Algazy, MD

(215) 662-8768 (215) 662-8947

New!! NCI-01-C-0011/NEOPHARM-MS-CI-01/NEOPHARM-SSIPE-001 – Phase I Study of SS1 (dsFv)-PE38 Immunotoxin in Patients With Advanced Malignancies That Express Mesothelin

SS1(dsFv)-PE38 immunotoxin

• Histologically confirmed malignancy

• Histologically confirmed malignancy
• At least 4 weeks since any prior therapy and recovered
• Must be at least 18 years old
• Must have life expectancy of at least 12 weeks

Robert Kreitman Mark C. Willingham

301-496-6947 336-716-4464

New!! NCCTG-N0021 – Phase II Study of Gemcitabine and Epirubicin in Patients With Malignant Pleural Mesothelioma

gemcitabine IV

• Must be at least 18 years old

• Histologically or cytologically confirmed malignant pleural mesothelioma
• No more than 1 prior chemotherapy regimen for malignant pleural mesothelioma
• More than 3 weeks since prior chemotherapy
• No prior gemcitabine or epirubicin

• Life expectancy of at least 12 weeks

Michael J. O'Connell

507-284-2511

New!! CRC-BOC-L52 - Phase III Randomized Study of Radiotherapy in the Prevention of Metastatic Skin Nodules Following Invasive Diagnostic Procedures in Patients With Malignant Mesothelioma

Radiotherapy

• Histologically proven malignant pleural mesothelioma by chest drain insertion, pleural aspiration, pleural biopsy, and/or thoracoscopy within the past 3 weeks

• No prior local radiotherapy for malignant mesothelioma

• No other invasive procedures to the same chest site during and for 1 year after study

Noelle O'Rourke

0-414-211-1738

NCI-99-C-0129/NCI-T99-0012 - Phase I Study of Decitabine Mediated Induction of Tumor Antigen and Tumor Suppressor Gene Expression in Patients With Unresectable Lung or Esophageal Cancer, or Malignant Pleural Mesothelioma

• Must be at least 18 years old

• At least 6 months

• Histologically or cytologically proven unresectable primary small cell lung cancer (SCLC) or non-small cell lung cancer (NSCLC), unresectable esophageal cancer, malignant pleural mesothelioma, or pleural effusions secondary to extrathoracic malignancies

• Disease must be able to be readily biopsied by endoscopy or percutaneous fine needle aspiration

• At least 30 days since prior biologic therapy

• At least 30 days since other prior chemotherapy

• At least 30 days since prior radiotherapy (14 days for localized radiotherapy to nontarget lesions) and recovered

David S. Schrump

301-496-2127

ALFACELL-P30-302, NCI-V97-1273 - Phase III Randomized Study of P-30 Protein (Onconase) With or Without Doxorubicin in Patients with Malignant Mesothelioma

Contact Stanislaw Marian Mikulski for details regarding therpay.

• Histologically proven malignant mesothelioma

• No more than one prior systemic chemotherapy regimen

• At least 6 weeks since prior chemotherapy

• Prior radiation therapy is allowed (except for myocardium radiation) provided disease is progressive or recurrent

• Must be at least 21 years old

Stanislaw Marian Mikulski

973-748-8082

NCI-00-C-0088 - Phase I Study of Inhaled Doxorubicin in Patients With Advanced Solid Tumors Affecting the Lungs

• doxorubicin every 3 weeks for up to 3 doses

• Histologically proven advanced cancer not curable by standard chemotherapy, radiotherapy, or surgery

• At least 4 weeks since prior biologic therapy and recovered
• No prior trastuzumab (Herceptin)

• No concurrent respiratory drugs via inhaler or nebulizer
• No other concurrent experimental drug

• Must be at least 18 years old
• Must have life expectancy of at least 3 months

David S. Schrump

301-496-2127

SWOG-S9810 - Phase II Study of Gemcitabine Plus Cisplatin in Patients with Unresectable Malignant Mesothelioma of the Pleura

• cisplatin IV over 1-2 hours followed immediately by doxorubicin IV over 15-30 minutes on days 1-3 and oral tamoxifen twice daily on days 4-17. Treatment continues every 3 weeks in the absence of the total cumulative doxorubicin dose reaching at least 500 mg/m2, disease progression, or unacceptable toxicity. Patients who achieve partial remission (PR) undergo local surgery or radiotherapy, if feasible, to convert PR to complete remission.

• Histologically proven soft tissue sarcoma, glioma, mesothelioma, hepatoma, thyroid cancer, or adrenal cancer with clinical, radiological, or histologic evidence of incurability

• No more than 1 prior chemotherapy regimen
• No prior anthracycline or cisplatin
• At least 3 weeks since other prior chemotherapy and recovered
• No prior radiotherapy to more than 25% of bone marrow
• At least 3 weeks since other prior radiotherapy and recovered
• Must be 65 years old or younger
• No congestive heart failure
• No severe, uncontrolled hypertension

Stan Z. Gertler

613-737-7700 ext 6880

LSUMC-3591/NCI-V00-1604 - Phase I Study of Intrapleurally Administered PA-1-STK Modified Ovarian Carcinoma Vaccine and Ganciclovir in Patients With Stage I, II, or III Malignant Mesothelioma

• Patients receive PA-1-STK modified ovarian carcinoma vaccine intrapleurally on day 1 followed by ganciclovir IV over 1 hour for 7 days beginning on day 1. Patients in the first 2 cohorts receive 1 course of treatment only. In all subsequent cohorts, treatment repeats every 3 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity.

Eligibility*:

• Histologically confirmed stage I, II, or III malignant mesothelioma

• At least 6 weeks since prior chemotherapy
• No concurrent steroid treatment
• At least 6 weeks since prior radiotherapy
• No significant history of heart disease
• No frequent angina
• No myocardial infarction within the past 6 months
• No congestive heart failure requiring daily treatment

Paul O. Schwarzenberger

504-568-6294

NYU-9850/NCI-G99-1575/MDA-FDR001234/MDA-ID-95209 - Phase II Clinical Study of a Liposomal-Cisplatin Analogue (L-NDDP) Administered Intrapleurally in Patients with Malignant Pleural Mesothelioma

• Pathologically confirmed malignant pleural mesothelioma
• At least 3 weeks since prior biologic therapy
• No concurrent immunotherapy
• No prior chemotherapy
• No concurrent chemotherapy
• At least 3 weeks since prior hormonal therapy
• No concurrent hormonal therapy
• No prior chest radiotherapy
• At least 3 weeks since other prior radiotherapy
• No concurrent radiotherapy
• At least 2 weeks since major surgery other than biopsy
• At least 3 weeks since use of any other investigational medication
• No concurrent use of any other investigational medications
• Must be at least 18 years old

Abraham Chachoua

212-263-6485

BRI-MA-2 - Phase II Study of Antineoplastons A10 and AS2-1 in Patients with Stage IV Mesothelioma

• Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 by intravenous injection six times per day until the maximum dose is reached.

• Histologically confirmed stage IV mesothelioma that is unlikely to respond to existing therapy and for which no curative therapy exists
• At least 4 weeks since prior immunotherapy and recovered
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
• At least 8 weeks since prior radiation therapy (or less if multiple tumors) and recovered
• No uncontrolled hypertension
• No history of congestive heart failure
• Must be at least 18 years old

Stanislaw R. Burzynski,

713-335-5697

CLB-39807 - Phase II Study of Capecitabine in Patients With Malignant Mesothelioma

• Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

• Histologically proven malignant mesothelioma not amenable to potentially curative radiotherapy or surgery
• No other concurrent chemotherapy
• No prior systemic cytotoxic chemotherapy for malignant mesothelioma
• No concurrent hormonal therapy except the following:
• Steroids administered for adrenal failure
• Hormonal therapy administered for nonmalignant conditions (e.g., insulin for diabetes) Intermittent use of dexamethasone as an antiemetic
• At least 4 weeks since prior radiotherapy
• At least 2 weeks since prior major surgery
• Must be at least 18 years old

Gregory Otterson

614-293-6786

CAN-OTT-9401/NCI-V94-0566 - Phase II Study of Cisplatin/Doxorubicin/Tamoxifen for Incurable Soft Tissue and Endocrine Malignancies

• Patients receive cisplatin IV over 1-2 hours followed immediately by doxorubicin IV over 15-30 minutes on days 1-3 and oral tamoxifen twice daily on days 4-17. Treatment continues every 3 weeks in the absence of the total cumulative doxorubicin dose reaching at least 500 mg/m2, disease progression, or unacceptable toxicity. Patients who achieve partial remission (PR) undergo local surgery or radiotherapy, if feasible, to convert PR to complete remission.

• Histologically proven soft tissue sarcoma, glioma, mesothelioma, hepatoma, thyroid cancer, or adrenal cancer with clinical, radiological, or histologic evidence of incurability
• No more than 1 prior chemotherapy regimen
• At least 3 weeks since other prior chemotherapy and recovered
• No prior radiotherapy to more than 25% of bone marrow
• At least 3 weeks since other prior radiotherapy and recovered
• No congestive heart failure
• No severe, uncontrolled hypertension

Stan Z. Gertler,

613-737-7700 ext 6880

UCCRC-NCI-44/NCI-44 - Phase II Study of SU5416 in Patients With Unresectable Malignant Mesothelioma

• Within 2 weeks of staging procedures, patients receive raltitrexed IV over 15 minutes on day 1. Treatment repeats every 3 weeks for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity.

• Histologically proven inoperable malignant mesothelioma
• At least 1 target lesion with measurable disease in at least 1 dimension (20 cm or more with conventional techniques OR 10 cm or more with spiral CT scans)
• At least 4 weeks since prior radiotherapy
• Prior pleurodesis allowed except with cytotoxic drugs (e.g., bleomycin) Concurrent pleurodesis with noncytotoxic drugs allowed
• Must be at least 18 years old

Giuseppe Giaccone

31-20-444-43-00

EORTC-08983 - Phase III Randomized Study of Cisplatin With or Without Raltitrexed in Patients With Malignant Pleural Mesothelioma

• Patients are stratified according to performance status (0 vs 1-2) and WBC count (less than 8,300/mm3 vs 8,300/mm3 or more). Patients are randomized to one of two treatment arms.

• Histologically confirmed malignant pleural mesothelioma
• No other prior or concurrent chemotherapy before first disease progression
• At least 1 month since prior investigational drugs

Jan Van Meerbeeck

31 10 4391437

ALFACELL-P30-302/NCI-V97-1273 - Phase III Randomized Study of P-30 Protein (Onconase) With or Without Doxorubicin in Patients with Malignant Mesothelioma

• This is a randomized, open label, controlled, multicenter study. Patients are randomized to one of two treatment arms.

• Histologically proven malignant mesothelioma
• At least 6 weeks since prior chemotherapy
• Prior radiation therapy is allowed (except for myocardium radiation) provided disease is progressive or recurrent
• Must be at least 21 years old

Stanislaw Marian Mikulski

973-748-8082

*Please note that the clinical trials listed on this page have additional specific requirements. Call contacts listed for each trial for more detailed information.