Decitabine in Treating Patients With Advanced Solid Tumors

• ClinicalTrials.gov Identifier: NCT00030615
• Recruitment Status: Completed
• First Posted: January 27, 2003
• Last Update Posted: February 7, 2013
• Sponsor: National Cancer Institute (NCI)
• Information provided by (Responsible Party): National Cancer Institute (NCI)

Tracking Information

• First Submitted Date: February 14, 2002
• First Posted Date: January 27, 2003
• Last Update Posted Date: February 7, 2013
• Study Start Date: December 2001
• Actual Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 6, 2013): Maximum tolerated dose determined by dose-limiting toxicities graded according to CTC 2.0 toxicity criteria [ Time Frame: 6 weeks ]
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Decitabine in Treating Patients With Advanced Solid Tumors
• 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
• Brief Summary: This phase I trial is studying the side effects and best dose of decitabine in treating patients with advanced solid tumors that have not responded to previous treatment. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

Detailed Description

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose of decitabine in patients with advanced solid tumors.

II. Determine the toxic effects of this drug in these patients. III. Determine the dose of this drug with biologic activity in these patients. IV. Determine the pharmacokinetics of this drug in these patients. V. Determine clinical response to this drug in these patients.

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.

• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Male Breast Cancer
• Recurrent Bladder Cancer
• Recurrent Breast Cancer
• Recurrent Melanoma
• Stage III Melanoma
• Stage IV Bladder Cancer
• Stage IV Breast Cancer
• Stage IV Melanoma
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

• Drug: decitabine
  Given IV
  Other Names:

  • 5-aza-dCyd
  • 5AZA
  • DAC
• Other: pharmacological study
  Correlative studies
  Other Name: pharmacological studies
• Other: laboratory biomarker analysis
  Correlative studies

Study Arms

Experimental: Treatment (decitabine)

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 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.

Interventions:

• Drug: decitabine
• Other: pharmacological study
• Other: laboratory biomarker analysis

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 20, 2007): 24
• Original Enrollment: Not Provided
• Study Completion Date: Not Provided
• Actual Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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
• Male or female
• Performance status - ECOG 0-1
• Hemoglobin at least 9.0 g/dL
• Platelet count at least 100,000/mm^3
• WBC at least 3,500/mm^3
• Absolute granulocyte count at least 1,500/mm^3
• No coagulation disorders
• 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
• Creatinine no greater than 1.5 times ULN
• No major cardiovascular system illness
• No major respiratory system illness
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• No major systemic infection
• At least 1 month since prior radiotherapy
• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00030615
• Other Study ID Numbers: NCI-2012-02727; OC-01-01; U01CA062505 ( U.S. NIH Grant/Contract ); CDR0000069182 ( Registry Identifier: PDQ (Physician Data Query) )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: National Cancer Institute (NCI)
• Study Sponsor: National Cancer Institute (NCI)
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jeffrey Weber; University of Southern California

• PRS Account: National Cancer Institute (NCI)
• Verification Date: February 2013