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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Brief Summary

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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.

Detailed Description

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OBJECTIVES:

I. Determine the safety, tolerability, and toxicity of oral 3-AP in patients with advanced solid tumors.

II. Determine the maximum tolerated dose and recommended phase II dose of this drug in these patients.

III. Determine the oral bioavailability and pharmacokinetics of this drug. IV. Assess tumoral expression of genes involved in response and resistance to 3-AP.

V. Observe and record any tumor response in these patients.

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive a one time dose of 3-AP IV over 2 hours on day -7. Patients then receive oral 3-AP twice daily on days 1-3, 8-10, and 15-17. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of oral 3-AP until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Blood samples for pharmacokinetic analysis are collected periodically over 8 hours after the IV dose of 3-AP and after the first oral dose of 3-AP during course 1.

After completion of study treatment, patients are followed periodically.

Conditions

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Unspecified Adult Solid Tumor, Protocol Specific

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I

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.

Group Type EXPERIMENTAL

triapine

Intervention Type DRUG

Given IV and orally

pharmacological study

Intervention Type OTHER

correlative study

laboratory biomarker analysis

Intervention Type PROCEDURE

Correlative study

Interventions

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triapine

Given IV and orally

Intervention Type DRUG

pharmacological study

correlative study

Intervention Type OTHER

laboratory biomarker analysis

Correlative study

Intervention Type PROCEDURE

Other Intervention Names

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3-AP OCX-191 pharmacological studies

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yun Yen

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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City of Hope

Duarte, California, United States

Site Status

Countries

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United States