Decitabine With or Without Interferon Alfa-2b in Treating Patients With Unresectable or Metastatic Solid Tumors

NCT00701298 | Terminated Phase 1

• 6 other identifiers: NCI-2009-00295CDR0000597624NVCI-0725NVCI 07-258224R21CA122270
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial is studying the side effects of decitabine when given together with or without interferon alfa-2b, and the best dose of interferon alfa-2b, in treating patients with unresectable or metastatic solid tumors. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as interferon alfa-2b, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether decitabine is more effective when given with or without interferon alfa-2b in treating solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (3)

• Toxicities as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

  The type, frequency, and severity of each toxicity will be reported.

  Up to 28 days

• Dose-limiting toxicity (DLT) of pegylated interferon alfa-2b when given with decitabine as assessed by NCI CTCAE version 3.0

  DLT is defined as grade III drug-related non hematologic and/or grade IV drug-related hematologic toxicity.

  First 28-day course

• Maximum-tolerated dose (MTD) of pegylated interferon alfa-2b when given with decitabine as assessed by NCI CTCAE version 3.0

  The MTD will be the dose level where not more than 1 case of a specific grade III-IV drug-related toxicity is observed, and either 2+toxicities have been observed at the next highest dose level, or the maximum dose-level of PEG-Intron has been reached.

  First 28-day course

Secondary Outcomes (3)

• Global (genomic) DNA methylation changes by high-performance liquid chromatography (HPLC)

  Baseline to up to day 1 of course 2

• Changes in expression of methylation-regulated genes in human biological tissues

  Baseline to up to day 1 of course 2

• Complete and partial response rates

  Up to 1 year

Study Arms (2)

Group 1 (chemotherapy)

ACTIVE COMPARATOR

Patients receive decitabine IV over 1 hour on days 1-5 and 8-12. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients whose disease is not responding after the first course may crossover to group 2.

Drug: decitabine; Other: laboratory biomarker analysis

Group 2 (chemotherapy and antineoplastic agent)

EXPERIMENTAL

Patients receive decitabine as in group 1 and pegylated interferon alfa-2b subcutaneously on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Biological: peginterferon alfa-2b; Drug: decitabine; Other: laboratory biomarker analysis

Interventions

peginterferon alfa-2b BIOLOGICAL

Given SC

Also known as: PEG-IFN alfa-2b, pegylated interferon alfa-2b, polyethylene glycol IFN-A2b

Group 2 (chemotherapy and antineoplastic agent)

decitabine DRUG

Given IV

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

Group 1 (chemotherapy); Group 2 (chemotherapy and antineoplastic agent)

laboratory biomarker analysis OTHER

Correlative studies

Group 1 (chemotherapy); Group 2 (chemotherapy and antineoplastic agent)

Eligibility Criteria

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

You may qualify if:

• Biopsy-proven solid tumor
• Metastatic or unresectable disease
• Tumor amenable to biopsy
• No curative or more effective treatment for this disease exists, in the opinion of the investigator
• Measurable disease by scans as assessed by RECIST criteria
• No untreated brain metastasis
• No longer receiving steroid therapy for previously treated brain metastasis
• Zubrod performance status of 0-2
• Bilirubin ≤ 1.5 times upper limit normal (ULN)
• SGOT or SGPT ≤ 2.5 times ULN (≤ 5 ULN if hepatic metastases present)
• Serum creatinine ≤ 1.5 times ULN
• Creatinine clearance ≥ 50 mL/min
• ANC \> 1,500/μL
• Platelet count \> 100,000/μL
• Hemoglobin \> 9 g/dL (transfusion allowed)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Nevada Cancer Institute-Summerlin Campus

Las Vegas, Nevada, 89135, United States

Location

MeSH Terms

Interventions

peginterferon alfa-2b; Decitabine

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

• Wolfram Samlowski

  Nevada Cancer Institute-Summerlin Campus

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 18, 2008
• First Posted: June 19, 2008
• Study Start: April 1, 2009
• Primary Completion: October 1, 2010
• Last Updated: February 24, 2014

Record last verified: 2011-10

Locations

US (1)