NCT00024323

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining 3-AP with cisplatin in treating patients who have advanced cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2001

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2001

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 20, 2003

Completed
Last Updated

July 18, 2013

Status Verified

November 1, 2002

First QC Date

September 13, 2001

Last Update Submit

July 17, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

cisplatinDRUG
triapineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed progressive malignant disease that has failed at least 1 conventional treatment or is unlikely to respond to current therapy * Measurable or evaluable disease * Elevated serum tumor marker considered evaluable disease * No known active CNS metastases * Previously treated CNS metastases with no evidence of new CNS metastases allowed if stable for at least 2 months PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * More than 3 months Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL (transfusion allowed) * No active bleeding or coagulation disorder (except occult blood related to gastrointestinal cancer) Hepatic: * Bilirubin no greater than 2.0 mg/dL * ALT and AST no greater than 3 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 5 times ULN * PT and PTT no greater than 1.5 times ULN Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * No active heart disease * No myocardial infarction within the past 3 months * No symptomatic coronary artery disease * No uncontrolled arrhythmias * No uncontrolled congestive heart failure Pulmonary: * No moderate to severe compromise of pulmonary function Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active infectious process * No pre-existing severe hearing impairment * No grade 2 or greater neuropathy * No other life threatening illness * No prior severe allergic reaction to cisplatin * No mental deficits and/or psychiatric history that would preclude study * No persistent chronic toxic effects from prior chemotherapy greater than grade 1 PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 2 weeks since prior biologic therapy Chemotherapy: * More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * At least 3 months since prior cisplatin or platinum analogue * No prior 3-AP Endocrine therapy: * At least 2 weeks since prior hormonal therapy Radiotherapy: * More than 3 weeks since prior radiotherapy Surgery: * At least 3 weeks since prior major surgery and recovered Other: * No other concurrent investigational drugs * No other concurrent nephrotoxic drugs (e.g., aminoglycoside antibiotics)

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

Sponsors & Collaborators

Study Sites (2)

Arizona Clinical Research Center

Tucson, Arizona, 85712, United States

Location

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

Related Publications (1)

  • Kunos CA, Chu E, Beumer JH, Sznol M, Ivy SP. Phase I trial of daily triapine in combination with cisplatin chemotherapy for advanced-stage malignancies. Cancer Chemother Pharmacol. 2017 Jan;79(1):201-207. doi: 10.1007/s00280-016-3200-x. Epub 2016 Nov 22.

    PMID: 27878356DERIVED

MeSH Terms

Interventions

Cisplatin3-aminopyridine-2-carboxaldehyde thiosemicarbazone

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Mario Sznol, MD

    Vion Pharmaceuticals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2001

First Posted

June 20, 2003

Study Start

March 1, 2001

Study Completion

June 1, 2003

Last Updated

July 18, 2013

Record last verified: 2002-11

Locations

US(2)