Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Intrapleural BG00001 in Treating Patients With Malignant Pleural Mesothelioma or Malignant Pleural Effusions

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	18 and over	NCI	UPCC-01502 NCT00066404

Objectives

1. Determine the safety and toxicity of intrapleural BG00001 in patients with malignant pleural mesothelioma or malignant pleural effusions.
2. Determine the maximum tolerated dose of this drug in these patients.
3. Determine the success of gene transfer/interferon beta gene expression in patients treated with this drug.
4. Determine systemic and intrapleural cytokine responses and cellular and humoral immune response in patients treated with this drug.
5. Determine, preliminarily, tumor response in patients treated with this drug.

Entry Criteria

Disease Characteristics:

• One of the following histologically or cytologically confirmed diagnoses:
  • Malignant pleural mesothelioma
  • Metastatic malignancy to the pleural space
    • Originating from 1 of the following sites:
      • Lung
      • Breast
      • Gastrointestinal organs
      • Genitourinary organs
      • Malignant melanoma
    • Failed prior standard therapy comprising chemotherapy, radiotherapy, and/or hormonal therapy
• Measurable or evaluable disease
• Pleural space involved with tumor accessible for pleural catheter insertion
• No malignant pleural effusions secondary to lymphoma or sarcoma
• No rapidly re-accumulating, symptomatic pleural effusions after thoracentesis or pleural catheter insertion that require immediate mechanical or chemical pleurodesis
• No known brain metastases
  • Previously treated brain metastases with no evidence of active growth are allowed
• Hormone receptor status:
  • Not specified

Prior/Concurrent Therapy:

Biologic therapy

• More than 4 weeks since prior biologic therapy
• No prior bone marrow transplantation, including stem cells
• No immunological drugs during and for at least 2 months after study therapy

Chemotherapy

• See Disease Characteristics
• No chemotherapy during and for at least 2 months after study therapy

Endocrine therapy

• See Disease Characteristics
• Concurrent hormonal therapy allowed if maintained at dose received prior to study entry
• No concurrent steroids

Radiotherapy

• See Disease Characteristics
• More than 4 weeks since prior radiotherapy
• No radiotherapy during and for at least 2 months after study therapy

Surgery

• At least 2 weeks since prior surgery

Other

• More than 4 weeks since prior cytotoxic agents
• No concurrent immunosuppressives or medication that can directly or indirectly suppress the immune system
• No other concurrent experimental therapies for pleural cancer

Patient Characteristics:

Age

• 18 and over

Sex

• Male or female

Menopausal status

• Not specified

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count at least 2,000/mm³
• Platelet count at least 100,000/mm³
• Hematocrit at least 30% (transfusion allowed)

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• ALT and AST no greater than 1.5 times ULN
• Alkaline phosphatase no greater than 1.5 times ULN
• PT and PTT no greater than 1.5 times normal
• No end-stage liver disease
• No chronic active hepatitis B (hepatitis B surface antigen negative)

Renal

• Creatinine no greater than 2.0 mg/dL
• No end-stage renal disease

Cardiovascular

• No unstable angina

Pulmonary

• FEV₁ greater than 50% of predicted (post-pleural drainage)
• No severe oxygen-dependent chronic obstructive pulmonary disease

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• No documented immunodeficiency
• No other malignancy within the past 5 years except nonmelanoma skin cancer or successfully treated localized malignancy of the bladder or prostate gland with no evidence of active disease
• No other life-threatening illness
• No known hypersensitivity to any component of study treatment

Expected Enrollment

A total of 3-18 patients will be accrued for this study.

Outline

This is a dose-escalation study.

Patients receive BG00001 via an intrapleural catheter on day 1.

Cohorts of 3-6 patients receive escalating doses of BG00001 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.

Patients are followed weekly for 1 month, biweekly for 1 month, monthly for 4 months, and then every 6 months for 15 years.

Trial Contact Information

Trial Lead Organizations

Abramson Cancer Center of the University of Pennsylvania

Daniel Sterman, MD, Protocol chair		Ph: 215-614-0984

Registry Information
Official Title		A Phase I Clinical Trial of Intrapleural Adenoviral-Mediated Interferon-beta (IFN-ß) Gene Transfer for Pleural Malignancies
Trial Start Date		2003-04-25
Registered in ClinicalTrials.gov		NCT00066404
Date Submitted to PDQ		2003-06-17
Information Last Verified		2005-12-06
NCI Grant/Contract Number		P01-CA66726-07, P30-CA16520

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