3-AP in Treating Patients With Advanced or Metastatic Solid Tumors

NCT00390052 | Completed Phase 1

• 5 other identifiers: NCI-2009-00139PHI-52CDR00005077317225U01CA062505
• 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 3-AP in treating patients with advanced or metastatic solid tumors. 3-AP may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose of oral 3-AP determined by dose-limiting toxicities graded according to the NCI CTCAE version 3.0

  28 days

Secondary Outcomes (1)

• Serum pharmacokinetics of oral triapine

  Baseline, day 4, and day 8

Study Arms (1)

Arm I

EXPERIMENTAL

Patients will receive a 2-hour infusion of 3-AP once in week 1. Beginning in week 2, they will receive 3-AP by mouth twice a day 3 days a week for 3 weeks. Treatment with 3-AP by mouth may repeat every 4 weeks for as long as benefit is shown.

Drug: triapine; Other: pharmacological study; Procedure: laboratory biomarker analysis

Interventions

triapine DRUG

Given IV and orally

Also known as: 3-AP, OCX-191

Arm I

pharmacological study OTHER

correlative study

Also known as: pharmacological studies

Arm I

laboratory biomarker analysis PROCEDURE

Correlative study

Arm I

Eligibility Criteria

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

Criteria: * Must be able to swallow * Histologically confirmed solid tumor * Advanced or metastatic disease * Measurable or evaluable disease * No known active CNS metastases * ECOG performance status 0-1 * Life expectancy \> 3 months * Progressive disease during \>= 1 prior standard therapy OR disease unlikely to respond to any currently available therapies * Patients with previously treated CNS metastases who have no evidence of new CNS metastases AND are stable for \>= 2 months are eligible * Platelet count \>= 100,000/mm\^3 * Hemoglobin \>= 10 g/dL (transfusions allowed) * Absolute neutrophil count \>= 1,500/mm\^3 * ALT and AST =\< 2.5 times upper limit of normal (ULN) * Alkaline phosphatase =\< 2.5 times ULN * Creatinine =\< 1.5 mg/dL OR creatinine clearance \>= 50 mL/min * Bilirubin normal * PT/PTT =\< 1.5 times ULN * FEV1 \>= 1.2 L * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception 2 weeks prior to and during study treatment * No mental deficits and/or psychiatric history that may preclude study treatment * No active heart disease, including any of the following: myocardial infarction within the past 3 months, symptomatic coronary artery disease or heart block, uncontrolled congestive heart failure * No moderate to severe compromise of pulmonary function * No active infection * No other life-threatening illness * No active coagulation disorder other than occult blood * No known positivity for glucose-6-phosphate dehydrogenase (G6PD) deficiency * Recovered from prior treatment * Prior gemcitabine allowed * More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * More than 3 weeks since prior radiotherapy or any other treatment for this cancer * No prior 3-AP * No concurrent radiotherapy * No other concurrent investigational agent

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

City of Hope

Duarte, California, 91010, United States

Location

MeSH Terms

Interventions

3-aminopyridine-2-carboxaldehyde thiosemicarbazone

Study Officials

• Yun Yen

  City of Hope Medical Center

  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: October 18, 2006
• First Posted: October 19, 2006
• Study Start: December 1, 2006
• Primary Completion: February 1, 2011
• Last Updated: December 16, 2013

Record last verified: 2013-12

Locations

US (1)