Decitabine in Treating Patients With Advanced Solid Tumors

Phase 1

Completed

• Conditions: 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
• Interventions: Drug: decitabine; Other: pharmacological study; Other: laboratory biomarker analysis

• Registration Number: NCT00030615
• Lead Sponsor: National Cancer Institute (NCI)

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 Timeline

• Study Start: 2001-12
• Study First Submitted: 2002-02-14
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2008-09
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-06
• Last Update Posted: 2013-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (decitabine)	laboratory biomarker analysis	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.
Treatment (decitabine)	pharmacological 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 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.
Treatment (decitabine)	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.

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose determined by dose-limiting toxicities graded according to CTC 2.0 toxicity criteria	6 weeks

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States