Decitabine in Treating Patients With Advanced Solid Tumors

NCT ID: NCT00030615

Last Updated: 2013-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-12-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

decitabine

Intervention Type: DRUG

Given IV

pharmacological study

Intervention Type: OTHER

Correlative studies

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

decitabine

Given IV

Intervention Type: DRUG

pharmacological study

Correlative studies

Intervention Type: OTHER

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

5-aza-dCyd; 5AZA; DAC; pharmacological studies

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Weber

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

University of Southern California

Los Angeles, California, United States

Countries

United States

Other Identifiers

OC-01-01

Identifier Type: -

Identifier Source: secondary_id

U01CA062505

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000069182

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02727

Identifier Type: -

Identifier Source: org_study_id