Decitabine in Treating Patients With Advanced Solid Tumors

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00030615
• Other study ID #: NCI-2012-02727
• Secondary ID: OC-01-01U01CA062
• Status: Completed
• Phase: Phase 1
• First received: February 14, 2002
• Last updated: February 6, 2013
• Start date: December 2001

Study information

• Verified date: February 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Breast Neoplasms, Male
• Male Breast Cancer
• Melanoma
• 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
• Urinary Bladder Neoplasms

Intervention

Drug:
• decitabine
Given IV

Other:
• pharmacological study
Correlative studies
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose determined by dose-limiting toxicities graded according to CTC 2.0 toxicity criteria		6 weeks	Yes