Decitabine in Treating Patients With Advanced Solid Tumors

NCT00030615 | Completed Phase 1

• 4 other identifiers: NCI-2012-02727OC-01-01U01CA062505CDR0000069182
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose determined by dose-limiting toxicities graded according to CTC 2.0 toxicity criteria

  6 weeks

Study Arms (1)

Treatment (decitabine)

EXPERIMENTAL

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.

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

Interventions

decitabine DRUG

Given IV

Also known as: 5-aza-dCyd, 5AZA, DAC

Treatment (decitabine)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (decitabine)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (decitabine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90033-0804, United States

Location

MeSH Terms

Conditions

Breast Neoplasms, Male; Urinary Bladder Neoplasms; Breast Neoplasms; Melanoma

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Jeffrey Weber

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2002
• First Posted: January 27, 2003
• Study Start: December 1, 2001
• Primary Completion: September 1, 2008
• Last Updated: February 7, 2013

Record last verified: 2013-02

Locations

US (1)