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

Alternate Title

Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	Over 18	NCI	DFCI-NCI-5708 NCI-5708, NCT00039091, 5708

Objectives

1. Determine the safety of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody in patients with ovarian epithelial cancer, melanoma, acute myeloid leukemia, myelodysplastic syndromes, or non-small cell lung cancer not previously treated with sargramostim (GM-CSF)-based autologous tumor vaccines.
2. Determine, preliminarily, the biologic activity and efficacy of this drug in these patients.

Entry Criteria

Disease Characteristics:

• Diagnosis of 1 of the following:
  • Ovarian epithelial cancer
    • Persistent or recurrent disease after primary surgery and chemotherapy
    • Received prior sargramostim (GM-CSF)-expressing autologous tumor cell vaccine
  • Melanoma
    • Stage IV disease
    • Received prior sargramostim (GM-CSF)-expressing autologous tumor cell vaccine
  • Acute myeloid leukemia (AML) meeting 1 of the following criteria:
    • Second relapse
    • First relapse with no option for bone marrow transplantation
    • Ineligible for immunosuppressive chemotherapy due to age or comorbid disease
  • Myelodysplastic syndromes (MDS)
  • Non-small cell lung cancer
    • Incurable by standard surgery, chemotherapy, and/or radiotherapy



• No standard curative treatment exists



• No immediate palliative therapy required



• Measurable disease



• No CNS metastases unless previously treated and stable for at least 3 months

Prior/Concurrent Therapy:

Biologic therapy:

• See Disease Characteristics
• At least 4 weeks since prior immunotherapy
• No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody

Chemotherapy:

• See Disease Characteristics
• At least 4 weeks since prior chemotherapy

Endocrine therapy:

• At least 4 weeks since prior hormonal therapy
• At least 4 weeks since prior systemic corticosteroids
• Concurrent inhaled or topical steroids allowed

Radiotherapy:

• At least 4 weeks since prior radiotherapy

Surgery:

• See Disease Characteristics
• At least 4 weeks since prior major surgical procedures

Other:

• At least 4 weeks since other prior therapy
• Recovered from prior therapy
• No other concurrent investigational drugs

Patient Characteristics:

Age:

• Over 18

Performance status:

• ECOG 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• WBC greater than 1,000/mm³*
• Platelet count greater than 75,000/mm³*

 [Note: * Except for patients with AML/MDS]

Hepatic:

• Bilirubin less than 2 times upper limit of normal (ULN)
• AST and ALT less than 2 times ULN

Renal:

• Creatinine less than 2 mg/dL

Immunologic

• No active infection
• No autoimmune disease requiring immunosuppressive treatment
• No active autoimmune disease threatening vital organ function
• No significant history of autoimmune disease that could be reactivated, including any of the following:
  • CNS (e.g., multiple sclerosis)
  • Eye (e.g., uveitis)
  • Intestine (e.g., irritable bowel disease)
  • Liver (e.g., hepatitis)
  • Kidney
  • Connective tissue disease (e.g., systemic lupus erythematosus, scleroderma, or polymyositis)
  • Heart (e.g., myocarditis)
• Possible autoimmune diseases that are managed with replacement therapy are allowed (e.g., diabetes mellitus or hypothyroid)

Other:

• No underlying medical condition that would preclude study participation
• No concurrent medical condition requiring systemic steroids
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception

Expected Enrollment

A total of 48 patients (12 per disease type; 36 previously treated with a sargramostim (GM-CSF)-expressing autologous tumor cell vaccine and 12 not previously treated with this vaccine) will be accrued for this study.

Outcomes

Biologic activity by radiology and pathology every 2 months

Outline

Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes on day 1. Courses repeat every 2 months in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly until disease progression.

Trial Contact Information

Trial Lead Organizations

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

F. Stephen Hodi, MD, Protocol chair		Ph: 617-632-5053; 866-790-4500

Registry Information
Official Title		Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 (Anti-CTLA-4) Humanized Monoclonal Antibody (MDX-CTLA-4 NSC # 732442 [previously # 720801]) in Patients Previously Vaccinated with GM CSF-Based Autologous Tumor Vaccines (CTEP Protocol Number P-5708) and Patients with Acute Myelogenous Leukemia/Myelodysplasia, and Non-Small Cell Lung Cancer Who Have Not Received Prior Vaccine
Trial Start Date		2002-03-22
Trial Completion Date		2003-07-15 (estimated)
Registered in ClinicalTrials.gov		NCT00039091
Date Submitted to PDQ		2002-03-29
Information Last Verified		2007-10-05
NCI Grant/Contract Number		CA06516

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