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

Alternate Title

Decitabine in Treating Patients With Advanced Solid Tumors

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed 18 and over NCI LAC-USC-0C0101 NCI-5353, NCT00030615

Objectives

1. Determine the maximum tolerated dose of decitabine in patients with advanced solid tumors.
2. Determine the toxic effects of this drug in these patients.
3. Determine the dose of this drug with biologic activity in these patients.
4. Determine the pharmacokinetics of this drug in these patients.
5. Determine clinical response to this drug in these patients.

Entry Criteria

Disease Characteristics:

• Diagnosis of advanced metastatic solid tumor for which all standard therapy has failed, including, but not limited to the following:
  • Stage III or IV melanoma
    • Mucosal melanoma allowed
    • No resectable stage III melanoma
  • Bladder cancer
  • Breast cancer



• No active symptomatic CNS disease



• No radiographically evident cerebral edema



• Hormone receptor status:
  • Not specified

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 1 month since prior radiotherapy

Surgery:

• Not specified

Other:

• At least 1 month since any prior anticancer therapy or adjuvant therapy
• No other experimental treatment within 30 days prior to, during, and for 30 days after study therapy

Patient Characteristics:

Age:

• 18 and over

Sex:

• Male or female

Menopausal status:

• Not specified

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Hemoglobin at least 9.0 g/dL
• Platelet count at least 100,000/mm³
• WBC at least 3,500/mm³
• Absolute granulocyte count at least 1,500/mm³
• No coagulation disorders

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT and SGPT less than 2.5 times ULN
• Hepatitis B surface antigen negative
• Hepatitis C antibody negative

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• No major cardiovascular system illness

Pulmonary:

• No major respiratory system illness

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• No major systemic infection

Expected Enrollment

Approximately 12-24 patients will be accrued for this study.

Outline

This is a dose-escalation, multicenter study.

Patients receive decitabine IV over 30 minutes on days 1-5 weekly for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of decitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 2 weeks.

Trial Contact Information

Trial Lead Organizations

USC/Norris Comprehensive Cancer Center and Hospital

Ana Aparicio, MD, Protocol chair		Ph: 323-865-0470; 800-865-0102

Registry Information
Official Title		A Phase I Study Of The Toxicities, Biologic And Clinical Effects Of Daily 5 Aza 2'Deoxycytidine (DAC), NSC 127716 (IND 50733) For Four Weeks In Patients With Advanced Malignancies
Trial Start Date		2002-02-27
Trial Completion Date		2008-09-16
Registered in ClinicalTrials.gov		NCT00030615
Date Submitted to PDQ		2001-12-04
Information Last Verified		2006-03-29
NCI Grant/Contract Number		CM17101, CA14089

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